CN105362671A - Medicinal preparation for treating hypomenorrhea with hyperinsulinemia - Google Patents
Medicinal preparation for treating hypomenorrhea with hyperinsulinemia Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicines, and discloses a medicinal preparation for treating hypomenorrhea with hyperinsulinemia and a preparation method of the medicinal preparation. The medicinal preparation is prepared by taking rhizoma polygonati, ficus lyrata, dried tangerine or orange peel, white atractylodes rhizome, acanthopanax root, astragalus membranaceus, herba lycopi, rhizoma cyperi, mucuna and levant cotton root as medicinal materials according to a certain weight ratio. The medicinal preparation has the efficacies of strengthening the spleen and nourishing stomach, nourishing the kidney and strengthening the essence, regulating qi-flowing for activating stagnancy, resolving dampness and eliminating phlegm, and regulating qi and blood, and can regulate the reproductive function, promote the menstruation to be regular and smooth, and enable the Chong-Ren blood sea has proper accumulation; the functions of the spleen and kidney are normal, the respiratoy metabolism is regular and smooth, dampness is removed and phlegm is eliminated, qi and blood are harmonious and smooth, and all the symptoms are eliminated. The medicinal preparation can be prepared into the oral preparation and is small in side effects, and a patient has good compliance and can take the medicinal preparation conveniently, so that the burden and pain of the patient are effectively alleviated, and the purpose of treating both symptoms and root causes is achieved.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of hypomenorrhea for the treatment of and accompany pharmaceutical composition of hyperinsulinemia and preparation method thereof.
Background technology
Menstruation is the outward manifestation of female reproduction physiological activity, and be also the most important physiological foundation of women, menoxenia is gynecological clinic commonly encountered diseases, comprises preceeded menorrhea, delayed menstrual cycle, menstruation successively irregular, menorrhagia, hypomenorrhea, menostaxis.Menstrual cycle is normal, and through measuring obvious minimizing, even drop is namely clean; Or menstrual period shorten less than two days, also lack person through amount, be all called " hypomenorrhea ", belong to menopathy.And for Hypomenorrhea, traditional theory thinks dialectical when point deficiency and excess, void is suffered from a deficiency of the kidney, blood deficiency, the deficiency of YIN, yang deficiency; There are cold coagulation, vapour lock, expectorant stagnant in fact.Hypomenorrhea and age, emotion are in close relations, can because of qi depression to blood stasis or cold, damp-phlegm of holding concurrently of holding concurrently, and retardance punching is appointed, and causes Hypomenorrhea, cyclomorphosis.Reality person mostly is young body and contains, and is not careful in one's diet or spirit is taken good care of oneself, and hinders in cold-damp or the stagnation of QI impairment of the spleen, biochemical unable, the excess syndrome of QI and blood diminuendo or the card of simulataneous insufficiency and excessive; Void person because of the age gradually long, plurimenorrhea, gestation and suckling trauma blood part, kidney qi degradation in addition, source deficiency stream is from few.
Insulin resistant can cause hyperinsulinemia, belong to metabolic disease, hyperinsulinism stimulates ovary synthetic androgen, reduce blood Sex Hormones white in conjunction with bladders, strengthen the effect that interstitialcellstimulating hormone (ICSH) (LH) stimulates thecacells synthetic androgen, excessive androgen suppresses follicle maturity at ovary, make follicular atresia in growth, can not dominant follicle be formed, cause ovulation failure, thus cause menoxenia.
At present, the medicine for the treatment of hypomenorrhea has Western medicine and the large class of Chinese medicine two, but this two classes medicine all can not prevent or treat hyperinsulinemia, and western medicine menoxenia administration time is long, curative effect is not thorough, not only easily cause gastrointestinal reaction, easily increase the weight of endocrine disturbance again, cause amenorrhea or menoxenia, even infertile, and although existing Chinese patent medicine preparation can treat female irregular menstruation, offer limited effectiveness, and the hyperinsulinemia occurred together to menoxenia is often invalid.The multiplex metformin of Modern medical therapy hyperinsulinemia, it can improve insulin sensitivity, reduce patient's blood insulin levels, and then the endocrine regulation that correction excessive androgen causes, thus recover there is ovulation menstruation, but recurrence or invalid problem after there is drug withdrawal, and metformin can make patient occur a series of gastrointestinal untoward reaction.
The traditional Chinese medical science is thought, hypomenorrhea companion hyperinsulinemia, insulin resistant etc. are Endocrine, belong to the disease category such as " delayed menstrual cycle ", " hypomenorrhea ", " amenorrhea ", " infertile ".The treatment of hypomenorrhea companion hyperinsulinemia is comparatively thorny, single pathogenesis is difficult to view and accurately embodies its complexity, multiformity in etiology and pathology, clinical manifestation many, how to play the advantage of Chinese medicine, inquire into effectively practical Therapeutic Method, improving clinical efficacy, is an important directions of this disease research.Combined by sick, card, find out rule, the traditional Chinese medical science or obtain good curative effect by its exclusive effect that is multi-faceted, Mutiple Targets.
Summary of the invention
For the deficiencies in the prior art, inventor is in conjunction with modern pharmacy on secret prescription handed down in the family from generation to generation basis, and hammer away, meticulous compatibility, provides a kind of pharmaceutical composition for the treatment of hypomenorrhea companion hyperinsulinemia.
For achieving the above object, the present invention adopts following technical scheme: a kind of pharmaceutical composition for the treatment of hypomenorrhea companion hyperinsulinemia, it is that medicinal raw material is according to certain weight distribution ratio elaborate by Rhizoma Polygonati, Caulis et Folium Fici beecheyanae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Herba Lycopi, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii.
Inventor sums up and thinks that clinical findings hypomenorrhea companion hyperinsulinemia female patient has the symptoms such as obesity, the soreness of waist are dizzy, weak, leucorrhea is many more.The traditional Chinese medical science thinks that the kidney being the origin of congenital constitution, the root of vigour, main store essential substances, main uterus, main reproduction; Congenital deficiency of kidney-QI, deficiency of kidney essence insufficiency of blood, rush conception vessel and decline, born of the same parents lose nourishing, and the sea of blood can not spill-over on time, and menstruation can not regularly and extremely; Insufficiency of kidney-YANG, decline of the fire from the gate of life, QI failing to transform into body fluid, gathers and wets into expectorant, blocks meridians, therefore causes hypomenorrhea.Disease is seen: menstruation is delayed menstrual period, hypomenorrhea, and the light matter of menstruation color is sticky, and gradually to amenorrhea, back is aching and limp, clear and thin leucorrhea, fear of cold, sleepy weak, light red tongue, and corpulent tongue is tender indentation, white and thin fur, deep-thready pulse or thin and delicate.This should blame in phlegm-damp of suffering from a deficiency of the kidney, control with invigorating the spleen and regulating the stomach, the kidney invigorating and essence nourishing with invigorating kidney qi, regulating qi-flowing for activating stagnancy, removing dampness expectorant, QI and blood regulating.Therefore Rhizoma Polygonati is apt to spleen invigorating tonify deficiency, the lung moistening and production of body fluid promoting, enriching kidney essence in side, flat benefit and not dry, Caulis et Folium Fici beecheyanae invigorating the spleen and replenishing QI, invigorating the spleen for eliminating dampness, bone and muscle strengthening, promoting blood circulation to remove obstruction in the collateral, two medicine 5 use, Liver and kidney is mended and muscle bone strengthening, and then blood stasis dispelling is stagnant to close taste, and QI and blood then passages through which vital energy circulates adjust, be monarch drug.Pericarpium Citri Reticulatae toil temperature, regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm; The Rhizoma Atractylodis Macrocephalae and middle QI invigorating, warming middle-JIAO, goes in taste wet, two medicine 5 drying dampness to eliminate phlegm, is especially applicable to weakness of the spleen and stomach and gives birth to damp-phlegm, the pungent micro-bitter temperature of Radix Et Caulis Acanthopanacis Senticosi, replenishing QI to invigorate the spleen, spleen reinforcing insufficiency of kidney-YANG, promoting blood circulation to remove obstruction in the collateral, both the kidney invigorating principal drug assistance enriching kidney essence, warming the spleen sun helps the Rhizoma Atractylodis Macrocephalae again, and Pericarpium Citri Reticulatae warming the spleenization is stagnant, is ministerial drug altogether.The sweet temperature of the Radix Astragali, invigorating QI to consolidate the body surface resistance, diuresis poison holding; Herba Lycopi and blood relax spleen, enter liver and control blood, can lead to nine orifices, can sharp joint, can adjust menstruation, can eliminating mass abdominal mass; Caulis Mucunae Wangii bone and muscle strengthening, tonifying blood and regulating menstruation, Radix Gossypii relieving cough and asthma, inducing menstruation to relieve menalgia; Rhizoma Cyperi acrid in the mouth can fall apart, and micro-hardship can be fallen, micro-sweet energy and, can QI and blood regulating, tool is adjuvant.All medicines close 5 scalable reproductive functions, impel menses to adjust suitable, and sea of blood accumulation degree of having is appointed in punching; Spleen normal renal function, the metabolism of water liquid is adjusted smooth, then wet eliminating the phlegm, QI and blood and suitable, and all diseases must be separated.
Preferably, treat a pharmaceutical composition for hypomenorrhea companion acne, it is made up of the medicinal raw material of following weight portion: Rhizoma Polygonati 15-30 part, Caulis et Folium Fici beecheyanae 30-50 part, Pericarpium Citri Reticulatae 10-20 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Et Caulis Acanthopanacis Senticosi 8-18 part, Radix Astragali 10-20 part, Herba Lycopi 11-16 part, Rhizoma Cyperi 8-13 part, Caulis Mucunae Wangii 20-30 part, Radix Gossypii 20-40 part.
Further preferably, treat a pharmaceutical composition for hypomenorrhea companion acne, it is made up of the medicinal raw material of following weight portion: Rhizoma Polygonati 18-26 part, Caulis et Folium Fici beecheyanae 38-46 part, Pericarpium Citri Reticulatae 12-17 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Et Caulis Acanthopanacis Senticosi 8-13 part, Radix Astragali 10-15 part, Herba Lycopi 11-16 part, Rhizoma Cyperi 8-13 part, Caulis Mucunae Wangii 20-30 part, Radix Gossypii 26-36 part.
Further preferably, treat a pharmaceutical composition for hypomenorrhea companion acne, it is made up of the medicinal raw material of following weight portion: Rhizoma Polygonati 20 parts, Caulis et Folium Fici beecheyanae 40 parts, Pericarpium Citri Reticulatae 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, the Radix Astragali 12 parts, Herba Lycopi 11 parts, Rhizoma Cyperi 10 parts, Caulis Mucunae Wangii 25 parts, Radix Gossypii 30 parts.
The pharmaceutical research present situation of the present invention's each medicinal raw material used is as described below.
Rhizoma Polygonati: [nature and flavor] are sweet is flat.[return through] returns spleen, lung, kidney channel.[function cures mainly] boosting qi and nourishing yin, spleen invigorating, lung moistening, kidney tonifying.For weakness of the spleen and stomach, fatigue and asthenia, xerostomia lack of appetite, deficiency of the lung cough caused by dryness, asthenia of essence and blood, interior-heat is quenched one's thirst.
Caulis et Folium Fici beecheyanae: [nature and flavor] are sweet; Light; Warm in nature.[return through] lung; Spleen; Kidney channel.[function cures mainly] invigorating middle warmer spleen invigorating; Wind-damp dispelling; Promoting blood circulation to remove obstruction in the collateral.The main deficiency of vital energy is weak; Extremity are aching and limp; Rheumatic arthralgia; Stiffness of the muscle and joint; Traumatic injury; Amenorrhea; Galactostasis.
Pericarpium Citri Reticulatae: [nature and flavor] are bitter, pungent, temperature.[return through] returns lung, spleen channel.[function cures mainly] regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
The Rhizoma Atractylodis Macrocephalae: [nature and flavor] are bitter, sweet, temperature.[return through] returns spleen, stomach warp.[function cures mainly] invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.
Radix Et Caulis Acanthopanacis Senticosi: [nature and flavor] pungent, micro-hardship, temperature.[return through] returns spleen, kidney, heart channel.[function cures mainly] replenishing kidney, strengthening waist; Benefiting vital QI for tranquillizing; Promoting blood circulation to remove obstruction in the collateral.Main kidney deficiency and bodily weakness; Soreness of the waist and knees; Children's's walking retardation in children; Insufficiency of the spleen weak; Deficiency of vital energy edema; Inappetence; Insomnia and dreamful sleep; Forgetful; Thoracic obstruction pain; Anemofrigid-damp arthralgia; Treating swelling and pain by traumatic injury.
The Radix Astragali: [nature and flavor] are sweet, temperature.[return through] returns lung, spleen channel.[function cures mainly] invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and burst for a long time and do not hold back, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.
Herba Lycopi: [nature and flavor] are bitter, pungent, tepor.[return through] returns liver, spleen channel.[function cures mainly] blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis is suffered from abdominal pain, edema.
Rhizoma Cyperi: [nature and flavor] pungent, micro-hardship, micro-sweet, flat.[return through] returns liver, spleen, tri-jiao channel.[function cures mainly] promoting QI circulation for relieving depression, menstruction regulating and pain relieving.For stagnation of QI due to depression of the liver, breast, the side of body, abdominal distention, dyspepsia, breast gastral cavity painful abdominal mass is vexed, and colic of cold type is suffered from abdominal pain, distending pain of the breast, menoxenia, amenorrhea dysmenorrhea.
Caulis Mucunae Wangii: [nature and flavor] are bitter, temperature.[function cures mainly] bone and muscle strengthening, menstruation regulating blood nourishing medicinal.Cure mainly poliomyelitis sequela, anemia, menoxenia, bones and muscles pain due to rheumatism.
Radix Gossypii: [nature and flavor] sweet in the mouth; Warm in nature.[return through] lung; Spleen; Liver Channel.[function cures mainly] relieving cough and asthma; Inducing menstruation to relieve menalgia.Main cough; Asthma; Have through uncomfortable; Metrorrhagia.
Pharmaceutical composition described above is that the Rhizoma Polygonati in above-mentioned prescription, Caulis et Folium Fici beecheyanae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Herba Lycopi, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii are extracted effective ingredient as active ingredient using proper method, this composition is independent or mix with medicine acceptable carrier, makes Chinese medicine preparation of the present invention according to galenic pharmacy routine techniques.
The present inventor finds under study for action, by optimized fabrication method, can when keeping active ingredient, remove impurity or the part without drug effect, reduce impurity to the interference of therapeutic effect, make this Chinese medicine preparation more effectively, effect is faster, and reduces the consumption of medicine thus, further reduces the misery of patient.The preparation method of this pharmaceutical composition provided by the invention, specifically comprises the steps:
(1) Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized, with 70% alcohol reflux 3 times, merge 3 extracting solution, concentrating under reduced pressure obtains rare extractum, upper polyamide column, 90% ethanol elution is used again after first colourless to effluent with 5% ethanol elution, collect ethanol elution, decompression recycling ethanol, to without alcohol taste, continues to be concentrated into the clear paste that relative density is 1.10-1.15 (60 DEG C of survey), lyophilization, obtains the dry cream of Chinese medicine;
(2) by Rhizoma Polygonati, Caulis et Folium Fici beecheyanae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii and Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi's second is extracted rear filtering residue and is decocted with water secondary, first time add water into medical material weight portion 4-8 doubly, decoct 1-2 hour, second time adds water as the 3-7 of medical material weight portion doubly decocts 1-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.08-1.12 (60 DEG C of survey), adding ethanol makes alcohol content reach 40%, leave standstill 12 hours, filter, filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.18-1.23 (60 DEG C of survey), lyophilization, obtain the dry cream of Chinese medicine,
(1) mixed homogeneously with the dry cream of Chinese medicine of (2) gained, be active ingredient of the present invention, this composition is independent or mix with medicine acceptable carrier, makes Chinese medicine preparation of the present invention according to galenic pharmacy routine techniques.
Those skilled in the art directly can be used as medicine on obtained pharmaceutical composition active ingredient basis of the present invention to take or add on pharmaceutics acceptable adjuvant routinely technique be prepared into required preparation.As the peroral dosage form of the solid dosage form such as conventional tablet, dispersible tablet, effervescent tablet, chewable tablet, capsule, granule, pill, powder can be made, the peroral dosage form of the liquid forms such as syrup, oral liquid, decoction also can be made.Therefore, in this pharmaceutical composition except effective ingredient, pharmaceutically acceptable adjuvant can also be contained.
Preferably, pharmaceutical composition of the present invention conveniently preparation technology is prepared into tablet, capsule, granule, most preferably is capsule.
The present invention be inventor through repeatedly studying, progressively improve, the good pharmaceutical composition of last successful a kind of curative effect, and demonstrated the curative effect of pharmaceutical composition of the present invention by clinical observation experiment further, particulars is as described below:
1 clinical data
1.1 physical data: include in May ,-2014 in October, 2013 my Out-patient Department in and be diagnosed as Hypomenorrhea companion hyperinsulinemia patient 116 example, Fasting insulin is higher than 18 μ U/mL (normal value 4 ~ 18 μ U/mL), fasting glucose is all at normal range (normal value 3.90 ~ 5.90mmol/L), 18 ~ 38 years old age, married 66 examples, unmarried 50 examples, the course of disease is the shortest 4 months, the longest 5.5 years, fat 64 example (BMI>=25kg/m
2), be divided into treatment group and matched group at random, each 58 examples.Year treatment group mean age (24.7 ± 3.7), average course of disease (1.6 ± 2.1) year; Year matched group mean age (25.1 ± 4.1), average course of disease (1.5 ± 2.2) year.Two groups of physical data, through statistical procedures difference nonsignificance (P > 0.05), have comparability.
1.2 diagnostic criteria
1.2.1 tcm diagnosis standard: the diagnostic criteria of the hypomenorrhea of " guideline of clinical investigations of new Chinese medicine treatment menoxenia " promulgated for 2002 according to Ministry of Health of the People's Republic of China;
Hypomenorrhea: hypomenorrhea refers to that menstrual cycle is normal, and menstrual blood loss comparatively constant obviously reduces, and even drop is namely clean, or through line time less than 2 days, through the menopathy that amount is also few.
Syndrome Differentiation of Traditional Chinese Medicine: the related content writing " guideline of clinical investigations of new Chinese medicine treatment menoxenia " of " Gynecology of Chinese Medicine " and Ministry of Health of the People's Republic of China promulgation in 2002 with reference to Zhang Yuzhen etc., formulate Standards of Chinese Medical Syndrome Differentiation, suffer from a deficiency of the kidney phlegm-damp disease type, disease is seen: menstrual blood volume is gradually few, or not enough through row, obesity, oppression sensation over the epigastrium, heavy sensation of the body is sleepy, waist soreness, irritable, color is dim, have clot; Tongue arteries and veins: the dark red or limit of tongue have petechia or corpulent tongue large, stringy and thready pulse or stringy and rolling pulse.
1.2.2 Western medicine diagnose standard: formulate according to " practical gynecologic endocrinology " the 2nd edition, " obstetrics and gynecology " the 7th edition teaching material related content.1. fasting insulin concentration >18 μ U/mL; 2. after oral 75g glucose, 30 ~ 60min reaches summit, exceedes 8 ~ 10 times of value on an empty stomach; 3. 3h returns to normal level not yet; 4. cardinal symptom: hypomenorrhea; 5. minor symptom: obesity, Hypomenorrhea etc.All meet above-mentioned 1. 2. one of 3. namely diagnosable with cardinal symptom person.Through B ultrasonic, gynecologial examination etc., to get rid of uterus and ovary organic disease.
1.3 exclusion standards: get rid of the diseases such as early pregnancy, Hypergonadotropic amenorrhea, low promoting sexual gland hormone amenorrhea, hyperprolactinemia, congenital adrenal cortical hyperplasia, pituitary tumor, hypothyroidism, hyperthyroidism.All not taking in before entering this research 1 month of all patients anyly may affect reproductive hormone and glycometabolic medicine.
1.4 Therapeutic Method:
Treatment group: the capsule that menstruation brings into use the embodiment of the present invention 1 to prepare on the 5th day, 2-4 grain, when taking to menstrual onset, subtracted clothes or withdrew, being a course for the treatment of, taking 3 months continuously with 3 months every day.
Matched group: oral administration of metformin, each 0.25g, day 3 times, takes before the meal half an hour, within 3 months, is 1 course for the treatment of.
1.5 treatment fore-and-aft observing indexs:
1.5.1 the change of menstruation--menstrual blood volume color, matter, passes through the time, menstrual cycle.
1.5.2 symptom score before and after treatment, standard: slight: less than 8 points, moderate: 8.5 ~ 12.5 points; Severe: more than 13 points.
Cardinal symptom standards of grading: spanomenorrhea 1/3 or less than 2d, whole menstrual cycle 7 ~ 10 pieces of paper washers 5 points; Reduce 1/2, share paper washer 3 ~ 6 pieces 6 points; Menstruation drop is namely clean, with paper washer 1 ~ 2 piece 7 points.Oppression sensation over the epigastrium 1 point, fat 1 point, sleepy 1 point of heavy sensation of the body, companion's clot 1 point, waist soreness 1 point, irritable 0.5 point, thready and rolling pulse 0.5 point, there is petechia 0.5 point on the dark red or limit of tongue.
1.5.3 the observation of adverse effect during medication: with or without occurring untoward reaction and record during observing medication, as gastrointestinal upset, anaphylaxis, vaginal bleeding time prolongation etc.As the person that occurs serious adverse reaction, discontinue medication immediately, exit this research.
1.6 statistical methods: adopt SPSS16.0 statistical software to calculate.Each numerical value with
represent, measurement data adopts t inspection, and enumeration data adopts χ
2inspection, with P < 0.05 for difference has statistical significance.
2 results
2.1 criterions of therapeutical effect: according to " guideline of clinical investigations of new Chinese medicine treatment menoxenia ", draft following criterion of therapeutical effect: recovery from illness: treat rear menstrual cycle, recover normal through amount, other transference cures, drug withdrawal 3 non-recidivists of menstrual cycle.Effective: menstrual blood volume increases by 1/3, and other transference cures alleviate, integration reduces 70% before comparatively treating, and drug withdrawal 3 menstrual cycle are without recidivist.Effective: treat rear menstrual cycle, through amount, comparatively treat front improvement menstrual period, other symptoms alleviate before comparatively treating, integration reduces 30 ~ 69% before comparatively controlling.Invalid: treatment after menstrual cycle, through amount and menstrual period without improvement, integration comparatively treat before reduce less than 30%.
2.2 observation of curative effect
2.2.1 two groups of patient's comparitive study: after above-mentioned 116 routine patient treatments, treatment group cures 21 examples, effective 27 examples, and take a turn for the better 9 examples, invalid 1 example, obvious effective rate 82.8%, total effective rate 98.3%; Matched group cures 11 examples, effective 13 examples, take a turn for the better 18 examples, do not heal 16 examples, obvious effective rate 41.4%, total effective rate 72.4%, treatment group compares with matched group obvious effective rate, total effective rate, and difference has statistical significance (being respectively P < 0.01 and P < 0.05).In table 1.
Table 1 liang group patient comparitive study (n%, example)
Note: compare with matched group, * P < 0.05, * * P < 0.01.
2.2.2 two groups of symptom integral compare: after treatment, two groups of symptom integral are all obviously less, statistical significance (P < 0.01) is had with comparing difference before treatment, compare between two groups after treatment, difference has statistical significance (P < 0.05), and treatment group symptom integral reduces more obvious.In table 2.
Table 2 is treated the two groups of symptom integral in front and back and is compared
Note: compare with before treatment, * P < 0.05, * * P < 0.01, compares with matched group after treatment,
#p < 0.05.
2.2.3 the observation of adverse effect during medication: have 3 routine patients to occur slight gastrointestinal reaction during matched group patient medication.18 routine patients are had to occur slight gastrointestinal reaction during matched group patient medication, 1 routine patient's upper abdomen dull pain; Treatment group compares with matched group, and difference has statistical significance, and treatment group less adverse effect, patient compliance is better.
In a word, compared with prior art, the present invention has following beneficial effect:
Selected by invention medicine, medical material compatibility is suitable, meets Chinese medicine and pharmacy and modern medicine theory, and comprehensively, medication is thoughtful, and all medicines close 5 scalable reproductive functions in legislation, impels menses to adjust suitable, and sea of blood accumulation degree of having is appointed in punching; Spleen normal renal function, the metabolism of water liquid is adjusted smooth, then wet eliminating the phlegm, QI and blood and suitable, then normally, menstruation comes at the appointed time menstrual blood volume.All diseases must be separated.
The present invention catches patient to suffer from a deficiency of the kidney originally, the mark of phlegm-damp, play pharmaceutical composition Mutiple Targets of the present invention, too many levels, multi-level comprehensive regulation effect, final eliminating pathogenic factor for supporting vital QI, treating both the principal and secondary aspects of a disease, side effect is less, patient compliance is better, and taking convenience, can alleviate patient's burden and misery effectively, the object for the treatment of both the principal and secondary aspects of a disease can be reached, wide popularization and application on clinic.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1
Prescription: Rhizoma Polygonati 20 parts, Caulis et Folium Fici beecheyanae 40 parts, Pericarpium Citri Reticulatae 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, the Radix Astragali 12 parts, Herba Lycopi 11 parts, Rhizoma Cyperi 10 parts, Caulis Mucunae Wangii 25 parts, Radix Gossypii 30 parts.
Preparation method:
(1) Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized, with 70% alcohol reflux 3 times, merge 3 extracting solution, concentrating under reduced pressure obtains rare extractum, upper polyamide column, 90% ethanol elution is used again after first colourless to effluent with 5% ethanol elution, collect ethanol elution, decompression recycling ethanol, to without alcohol taste, continues to be concentrated into the clear paste that relative density is 1.10-1.15 (60 DEG C of survey), lyophilization, obtains the dry cream of Chinese medicine;
(2) by Rhizoma Polygonati, Caulis et Folium Fici beecheyanae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii and Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi's second is extracted rear filtering residue and is decocted with water secondary, first time add water into medical material weight portion 4-8 doubly, decoct 1-2 hour, second time adds water as the 3-7 of medical material weight portion doubly decocts 1-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.08-1.12 (60 DEG C of survey), adding ethanol makes alcohol content reach 40%, leave standstill 12 hours, filter, filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.18-1.23 (60 DEG C of survey), lyophilization, obtain the dry cream of Chinese medicine,
(1) is mixed homogeneously with the dry cream of Chinese medicine of (2) gained, makes capsule according to galenic pharmacy routine techniques.
The present embodiment capsule every 0.45g is 2.2g containing crude drug.
Embodiment 2
Prescription: Rhizoma Polygonati 22 parts, Caulis et Folium Fici beecheyanae 45 parts, Pericarpium Citri Reticulatae 12 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, the Radix Astragali 12 parts, Herba Lycopi 15 parts, Rhizoma Cyperi 12 parts, Caulis Mucunae Wangii 20 parts, Radix Gossypii 35 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 3
Prescription: Rhizoma Polygonati 25 parts, Caulis et Folium Fici beecheyanae 45 parts, Pericarpium Citri Reticulatae 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, the Radix Astragali 10 parts, Herba Lycopi 12 parts, Rhizoma Cyperi 13 parts, Caulis Mucunae Wangii 30 parts, Radix Gossypii 26 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 4
Prescription: Rhizoma Polygonati 15 parts, Caulis et Folium Fici beecheyanae 30 parts, Pericarpium Citri Reticulatae 12 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, the Radix Astragali 15 parts, Herba Lycopi 12 parts, Rhizoma Cyperi 10 parts, Caulis Mucunae Wangii 30 parts, Radix Gossypii 31 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 5
Prescription: Rhizoma Polygonati 25 parts, Caulis et Folium Fici beecheyanae 30 parts, Pericarpium Citri Reticulatae 13 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, the Radix Astragali 16 parts, Herba Lycopi 16 parts, Rhizoma Cyperi 13 parts, Caulis Mucunae Wangii 25 parts, Radix Gossypii 30 parts.
Rhizoma Polygonati 15-30 part, Caulis et Folium Fici beecheyanae 30-50 part, Pericarpium Citri Reticulatae 10-20 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Et Caulis Acanthopanacis Senticosi 8-18 part, Radix Astragali 10-20 part, Herba Lycopi 11-16 part, Rhizoma Cyperi 8-13 part, Caulis Mucunae Wangii 26 parts, Radix Gossypii 34 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 6
Prescription: Rhizoma Polygonati 26 parts, Caulis et Folium Fici beecheyanae 40 parts, Pericarpium Citri Reticulatae 18 parts, the Rhizoma Atractylodis Macrocephalae 14 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, the Radix Astragali 15 parts, Herba Lycopi 12 parts, Rhizoma Cyperi 12 parts, Caulis Mucunae Wangii 26 parts, Radix Gossypii 28 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 7
Prescription: Rhizoma Polygonati 30 parts, Caulis et Folium Fici beecheyanae 45 parts, Pericarpium Citri Reticulatae 10 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, the Radix Astragali 15 parts, Herba Lycopi 12 parts, Rhizoma Cyperi 10 parts, Caulis Mucunae Wangii 24 parts, Radix Gossypii 36 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 8
Prescription: Rhizoma Polygonati 24 parts, Caulis et Folium Fici beecheyanae 44 parts, Pericarpium Citri Reticulatae 12 parts, the Rhizoma Atractylodis Macrocephalae 14 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, the Radix Astragali 12 parts, Herba Lycopi 11 parts, Rhizoma Cyperi 12 parts, Caulis Mucunae Wangii 24 parts, Radix Gossypii 35 parts.
Preparation method: carry out with reference to embodiment 1.
Embodiment 9
Prescription: Rhizoma Polygonati 20 parts, Caulis et Folium Fici beecheyanae 40 parts, Pericarpium Citri Reticulatae 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, the Radix Astragali 12 parts, Herba Lycopi 11 parts, Rhizoma Cyperi 10 parts, Caulis Mucunae Wangii 25 parts, Radix Gossypii 30 parts.
Preparation method:
(1) Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized, with 70% alcohol reflux 3 times, merge 3 extracting solution, concentrating under reduced pressure obtains rare extractum, upper polyamide column, 90% ethanol elution is used again after first colourless to effluent with 5% ethanol elution, collect ethanol elution, decompression recycling ethanol, to without alcohol taste, continues to be concentrated into the clear paste that relative density is 1.10-1.15 (60 DEG C of survey), lyophilization, obtains the dry cream of Chinese medicine;
(2) by Rhizoma Polygonati, Caulis et Folium Fici beecheyanae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii and Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi's second is extracted rear filtering residue and is decocted with water secondary, first time add water into medical material weight portion 4-8 doubly, decoct 1-2 hour, second time adds water as the 3-7 of medical material weight portion doubly decocts 1-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.08-1.12 (60 DEG C of survey), adding ethanol makes alcohol content reach 40%, leave standstill 12 hours, filter, filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.18-1.23 (60 DEG C of survey), lyophilization, obtain the dry cream of Chinese medicine,
(1) is mixed homogeneously with the dry cream of Chinese medicine of (2) gained, makes granule according to galenic pharmacy routine techniques.
Embodiment 10
Prescription: Rhizoma Polygonati 20 parts, Caulis et Folium Fici beecheyanae 40 parts, Pericarpium Citri Reticulatae 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, the Radix Astragali 12 parts, Herba Lycopi 11 parts, Rhizoma Cyperi 10 parts, Caulis Mucunae Wangii 25 parts, Radix Gossypii 30 parts.
Preparation method:
(1) Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized, with 70% alcohol reflux 3 times, merge 3 extracting solution, concentrating under reduced pressure obtains rare extractum, upper polyamide column, 90% ethanol elution is used again after first colourless to effluent with 5% ethanol elution, collect ethanol elution, decompression recycling ethanol, to without alcohol taste, continues to be concentrated into the clear paste that relative density is 1.10-1.15 (60 DEG C of survey), lyophilization, obtains the dry cream of Chinese medicine;
(2) by Rhizoma Polygonati, Caulis et Folium Fici beecheyanae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii and Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi's second is extracted rear filtering residue and is decocted with water secondary, first time add water into medical material weight portion 4-8 doubly, decoct 1-2 hour, second time adds water as the 3-7 of medical material weight portion doubly decocts 1-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.08-1.12 (60 DEG C of survey), adding ethanol makes alcohol content reach 40%, leave standstill 12 hours, filter, filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.18-1.23 (60 DEG C of survey), lyophilization, obtain the dry cream of Chinese medicine,
(1) is mixed homogeneously with the dry cream of Chinese medicine of (2) gained, makes tablet according to galenic pharmacy routine techniques.
Claims (10)
1. treat a pharmaceutical composition for hypomenorrhea companion hyperinsulinemia, it is characterized in that by Rhizoma Polygonati, Caulis et Folium Fici beecheyanae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Herba Lycopi, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii be that medicinal raw material is made.
2. pharmaceutical composition as claimed in claim 1, is characterized in that being made up of the medicinal raw material of following weight portion: Rhizoma Polygonati 15-30 part, Caulis et Folium Fici beecheyanae 30-50 part, Pericarpium Citri Reticulatae 10-20 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Et Caulis Acanthopanacis Senticosi 8-18 part, Radix Astragali 10-20 part, Herba Lycopi 11-16 part, Rhizoma Cyperi 8-13 part, Caulis Mucunae Wangii 20-30 part, Radix Gossypii 20-40 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: Rhizoma Polygonati 18-26 part, Caulis et Folium Fici beecheyanae 38-46 part, Pericarpium Citri Reticulatae 12-17 part, Rhizoma Atractylodis Macrocephalae 10-15 part, Radix Et Caulis Acanthopanacis Senticosi 8-13 part, Radix Astragali 10-15 part, Herba Lycopi 11-16 part, Rhizoma Cyperi 8-13 part, Caulis Mucunae Wangii 20-30 part, Radix Gossypii 26-36 part.
4. pharmaceutical composition as claimed in claim 3, is characterized in that being made up of the medicinal raw material of following preferred weight part: Rhizoma Polygonati 20 parts, Caulis et Folium Fici beecheyanae 40 parts, Pericarpium Citri Reticulatae 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, the Radix Astragali 12 parts, Herba Lycopi 11 parts, Rhizoma Cyperi 10 parts, Caulis Mucunae Wangii 25 parts, Radix Gossypii 30 parts.
5. the pharmaceutical composition as described in claim 1-4, is characterized in that preparation method comprises the steps:
(1) Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized, with 70% alcohol reflux 3 times, merge 3 extracting solution, concentrating under reduced pressure obtains rare extractum, upper polyamide column, 90% ethanol elution is used again after first colourless to effluent with 5% ethanol elution, collect ethanol elution, decompression recycling ethanol, to without alcohol taste, continues to be concentrated into the clear paste that relative density is 1.10-1.15 (60 DEG C of survey), lyophilization, obtains the dry cream of Chinese medicine;
(2) by Rhizoma Polygonati, Caulis et Folium Fici beecheyanae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Cyperi, Caulis Mucunae Wangii, Radix Gossypii and Pericarpium Citri Reticulatae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi's second is extracted rear filtering residue and is decocted with water secondary, first time add water into medical material weight portion 4-8 doubly, decoct 1-2 hour, second time adds water as the 3-7 of medical material weight portion doubly decocts 1-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.08-1.12 (60 DEG C of survey), adding ethanol makes alcohol content reach 40%, leave standstill 12 hours, filter, filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.18-1.23 (60 DEG C of survey), lyophilization, obtain the dry cream of Chinese medicine,
(1) mixed homogeneously with the dry cream of Chinese medicine of (2) gained, be active ingredient of the present invention, this composition is independent or mix with medicine acceptable carrier, makes Chinese medicine preparation of the present invention according to galenic pharmacy routine techniques.
6. pharmaceutical composition as claimed in claim 5, is characterized in that described pharmaceutical composition makes peroral dosage form.
7. pharmaceutical composition as claimed in claim 6, is characterized in that described peroral dosage form is tablet, dispersible tablet, effervescent tablet, chewable tablet, capsule, granule, pill, powder, syrup, oral liquid, decoction etc.
8. pharmaceutical composition as claimed in claim 7, is characterized in that described peroral dosage form is tablet, capsule or granule.
9. pharmaceutical composition as claimed in claim 8, is characterized in that described peroral dosage form is capsule.
10. the application of the arbitrary described pharmaceutical composition of claim 1-9 in the medicine of preparation treatment hypomenorrhea companion hyperinsulinemia.
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| Title |
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| 于跃 等: "抑囊助孕汤联合西药治疗多囊卵巢综合征随机平行对照研究", 《实用中医内科杂志》 * |
| 姚军 等: "多囊卵巢综合征与代谢综合征", 《中华糖尿病杂志》 * |
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