CN106237027B - It is a kind of to treat pharmaceutical composition of gynecological disease and preparation method thereof - Google Patents
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/287—Chrysanthemum, e.g. daisy
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- Immunology (AREA)
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- Medicines Containing Plant Substances (AREA)
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Abstract
The present invention relates to the field of Chinese medicines, and in particular to a kind of to treat pharmaceutical composition of gynecological disease and preparation method thereof.The medicine is made up of the raw material of following parts by weight：Flat bamboo joins 1~2 parts by weight, the naked parts by weight of post chrysanthemum 1~2.Medicine preparation piece agent, pill, powder, hard capsule, soft capsule, granule, the oral liquid.Preparation method is：Dry flat bamboo is joined, naked post chrysanthemum, and first time adds 11 times of amount water to soak 1 hour, decoction 1 hour, is added 4 times of amount decoctings to boil for the second time 1 hour, is merged decocting liquid, filter, filtrate concentrates, and dry, pulverize into fine powder, sieving is mixed, and loads hard shell capsules.The chromatographic condition of drug quality detection method is：Using HypersilDs chromatographic columns；Mobile phase：Ratio is 30：70 acetonitrile water；Detection wavelength：200nm；Column temperature：20℃；Flow velocity：1.0mL·min‑1；Sample size：10μL.
Description
Technical field
The present invention relates to the field of Chinese medicines, and in particular to a kind of flat bamboo participates in active medicine of naked post chrysanthemum and preparation method thereof.
Background technology
Stein-Leventhal syndrome（PCOS）It is the Female Genital Endocrine systemic disease of a kind of many causes, polymorphism, is blue or green
Phase in spring and Female in child bearing period clinic is multiple, common, one of difficult disease.The incidences of disease of the PCOS in Female in child bearing period be up to 6% ~
10%.There are some researches show have 75% anovulatory infertility, 26% ~ 37% amenorrhoea, 87% ~ 90% oligomenorrhea all may be with
PCOS is relevant.For PCOS treatment, the problem of ovulation rate, pregnancy rate and gestation are in the urgent need to address how is improved, is also
Treat in place of this sick difficult point, in recent years, Chinese medicine PCOS is from entirety, using the differentiation of disease with the dialectical method being combined
Diagnosis and treatment are carried out, very good clinical effectiveness is achieved.
1st, etiology and pathogenesis is studied
PCOS is clinical excessive and chronic anovulation is principal character using male sex hormone, show as oligomenorrhea or even amenorrhoea,
Infertile, crinosity, obesity, acne, acanthosis nigricans etc., are to cause that Women of Childbearing Age is infertile, the most common cause of disease of paramenia, be because
The pathological products such as visceral dysfunction, qi-blood disharmony, wet turbid phlegm-blood stasis are jammed a series of complex disease that uterus and skin are formed
Group.Modern medicine thinks that its cause of disease is related to many aspects such as heredity, endocrine, immune, metabolism, with hyperandrogenism and height
Insulinemia is principal character, the two PCOS morbidity in definite effect, it is not immediately clear.Consult traditional Chinese medical science ancient times text
Offer, find to have no the relevant name of disease of " Stein-Leventhal syndrome " in Chinese medical book, reproduction is not only had according to its clinical manifestation characteristic
Obstacle, and have metabolic disorder i.e.：Obesity, amenorrhoea, crinosity, infertile etc., according to the relevant discussion of ancient Chinese medicine doctor, this disease is belonged to
The category of the traditional Chinese medical science " amenorrhoea " " infertile ” " Disorder lumps in the abdomen ", sporadically appears in menstruation regulating, asks in the chapters such as heir, seed, and associated name of disease is also
Compare diversified, such as：Fertile people's amenorrhoea, infertile fertile people, amenorrhea, unsmooth menorrhea, the moon water it is obstructed, through collapsing, it is s.m.p, sub, disconnected absolutely
Thread, do not produce entirely.The etiology and pathogenesis for analyzing PCOS according to tcm theory finds that kidney qi virtual loss is the base of Stein-Leventhal syndrome
This interpretation of the cause, onset and process of an illness, the expert such as Penning well, You Zhaoling, Xia Gui city thinks that this disease is that, because of congenital kidney water virtual loss, menses is not enough, multiple because phlegm-blood stasis is solidifying
Caused by poly-, either kidney-yin deficiency or kidney-yang deficiency, will all occur because of the pathological change of the empty cause stasis of blood, cause punching to appoint stagnation of QI-blood, hinder
Ovum is discharged, or kidney yin last of the ten Heavenly stems water is not enough, and egg development can not be ripe, and phlegm wet accumulates resistance, and ovary changes in many capsule samples and arrived infertile；Poplar
Yue Ya etc. breeds weak it also holds that kidney deficiency is not enough, causes follicular development sluggish, the deficiency of vital energy promotes not enough, causes ovarian follicle to be difficult to pass through
Ovary and the locking that arrives, therefore cause infertile.Liver is viscus attriguted to wind and wood, easy perverse and unreasonable manner gram soil, then taste are restricted, transporting mistake department, and phlegm wet is jammed born of the same parents
Arteries and veins uterus, then can not take the photograph smart into pregnant；Stop up in skin then fat, crinosity.《Fu Qingzhu works on obstetrics and gynecology》Speech：" woman is kind to cherish how strongly fragrant, Liver Channel one
Disease ... is difficult in fertility.”《Married woman advises son class》Cloud：" feelings are not smooth, then punching appoint do not fill, then tire it is pregnant not by." therefore be believed that
Stagnation of liver qi is the topmost cause of disease of PCOS patient.The spleen being the foundation of acquired constitution, the strong fortune of temper, Xue Xunchang roads, blood it is prosperous and through adjusting.If spleen
Gas virtual loss, the biochemical weary source of qi and blood, or hypoactivity of spleen-YANG, transformation failure of spleen, accumulatively wet raise phlegm, functional activity of QI being not smooth, punching times are obstructed, and biochemical function is not
Foot, phlegm wet adipose membrane bet, accumulates stagnant uterus, then see through less, amenorrhoea, infertile etc., or phlegm wet adipose membrane accumulation, pent up in vivo, dipping four
Limb, muscle, then body is fat, crinosity.It is event PCOS weak for this with spleen kidney deficiency, phlegm wet is mark, and insufficiency of the spleen phlegm wet is PCOS morbidity
It is crucial.Blood-stasis internal-depression is then the common inducement of the disease,《Qianjin Yao Fang》Point out the original that " stopping in hemostasis, leaked in extravesated blood " is s.m.p
Therefore one；《The correction of the errors of medical works》Speech：" vigour was both empty, can not must reach in blood vessel, blood vessel must stop without gas and be the stasis of blood.Stagnation of blood stasis,
Punching, which is appointed, owes logical, and the sea of blood can not be overflowed as scheduled, delayed menstrual cycle；Blood stasis in the Chong and Ren Channels, blood must not under, then see amenorrhea；In hemostasis
Resistance, the escape of blood from vessels and channels and absurd row, it is seen that uterine bleeding；Uterus silt resistance vessels of the uterus then causes infertile.
In summary, PCOS is more causes qi depression to blood stasis because of kidney deficiency, phlegm stagnation, dampness-heat of liver channel etc., retention of water-damp in the body, metaplasia
Wet turbid, with the passing of time resolving sputum stagnation resolvation, the phlegm wet stasis of blood is mutually tied, and the uterus that is jammed, punching are appointed, and punching, which is appointed, loses money, dirty
Internal organs function and dysfunction of thoroughfare vessel and there is various clinical symptom, its etiology and pathogenesis always using liver depression, insufficiency of the spleen, kidney deficiency as
This, with blood stasis, phlegm wet, it is damp and hot for mark, clinical manifestation is using syndrome of intermingled deficiency and excess to be common.
2nd, therapeutic rule is studied
Based on the interpretation of the cause, onset and process of an illness such as kidney deficiency, phlegm wet, blood stasis, yin deficiency, the deficiency of yang, the deficiency of vital energy, more using kidney tonifying, resolving sputum, dampness removing, dissolving stasis,
QI invigorating, enrich blood, the therapeutic rules such as warm sun, kidney deficiency blood stasis type controlled with nourshing kidney promoting blood circulation, coordinating Chong and Conception Vessels, and spleen emptiness and wet sputum type is controlled with eliminating dampness
Phlegm, qi-regulating menstruation regulating, many scholars of phlegm and blood stasis think that PCOS is main relevant with kidney,liver,spleen functional disturbance, and Qin Zhu etc. passes through text
Offer research to find, the traditional Chinese medical science treats PCOS in recent years
Type is controlled with kidney-replenishing blood-nourishing, soothing liver-qi stagnation.Chinese traditional treatment focuses on benefit, tune, led to, but the complicated interpretation of the cause, onset and process of an illness of the PCOS causes of disease changes many
Sample, clinical manifestation is also various, and normal many diseases are simultaneously seen, therefore clinically should note accompanying symptoms while main symptom is held, need diagnosis and treatment with
Treatment based on disease differentiation is combined, while follow the treatment of women distinctive physiological period, over the course for the treatment of, also to pay special attention to it is spiritual because
The influence of element, based on long-time conditioning, haste brings no success.Tcm treatment method on PCOS is studied, and clinical doctor is seen by clinic
PCOS Symptoms are examined, with traditional Chinese medical science organic conception Coryza Treated by Syndrome Differentiation PCOS, various effective treatment methods are summed up.Disease
Card controls the prevailing model of always Chinese medicine diagnosis with reference to opinion, and for the different interpretation of the cause, onset and process of an illness of PCOS, clinical doctor is even more to sum up kidney tonifying
The different treatment methods such as phlegm method, invigorating kidney, promoting blood circulation method, liver heat removing and kidney replenishing method, clearing heat and promoting diuresis method, strengthening spleen and nourishing blood tonneau method.Zhong Xiaoling etc.
Burnt type PCOS patient 30 under the insufficiency of the kidney yang, dampness is treated using warm kidney blood-nourishing, the ruling by law of dissolving stasis tonneau, treated 3 cycles, always effectively
Rate is 86.67%, 76.67% treated higher than control group clomiphene.Liu Ying etc. is respectively adopted kidney tonifying and adjusts liver method and kidney tonifying resolving sputum
Kidney deficiency liver energy stagnation type and kidney deficiency phlegm-damp type patient 62 are treated in ruling by law, and it is 60.46% that liver method cure-remarkable-effectiveness rate is adjusted in as a result kidney tonifying, and effective percentage is
88.37%；Kidney tonifying Circulation Resolving Phlegm cure-remarkable-effectiveness rate is 52.64%, and effective percentage is 84.21%.Talk the basis such as brave and adjust menstruation with Chinese medicine for many years
The experience of circadian rhythm, proposes that Chinese medicine adjusts Zhou Fazhi to treat PCOS, medication follows postmenstruation enriching yin, the dialectical original of premenstruum (premenstrua) yang-tonifying
Then, enriching yin side, yang-tonifying side is made in the side's of sending medication, and according to physiological activity rule in the menstrual cycle, simplifies medication by stages, sequential fortune
With enriching yin side and yang-tonifying side's treatment PCOS menstrual disorder main symptoms, satisfactory effect.Chinese medicine cycling therapy refers to according to kidney tonifying-promoting blood circulation
Stagnation resolvation-kidney tonifying-promoting blood circulation for regulating menstruation, order periodicity Selection drug, copies the menstrual cycle to be treated.Hao Lanzhi uses artificial cycle
Therapy, uses kidney tonifying Gu Chong, helps with the method for stagnation resolvation menstruation regulating, from oral medicinal herb side is intended, and is divided into Kaohsiung in 4 stage plus-minus treatment PCOS
Hormone mass formed by blood stasis patient, as a result fully recovers 30, effective 10, invalid 6；Recover ovulation rate be 56.52%, pregnancy rate up to 41.67%,
Total effective rate 86.96%.The infertile patient 60 of rosy clouds Artificial menstrual cycle with Chinese herbal medicine therapy for treating Stein-Leventhal syndrome is accorded with, is as a result controlled
More 41, effective 12, invalid 7, effective percentage 88.33%.In addition, Chinese traditional treatment PCOS also has acupuncture and moxibustion therapy, Chinese medicine to add
The therapy such as acupuncture therapeutic alliance and plantar reflecting region massage treatment, obtains preferable curative effect in clinic.
3rd, prescription application study
It is clinically the more commonly used by prescription application for the treatment of PCOS, mainly include compound plus-minus treatment, classical prescription treatment, in
Patent medicine treatment, famous physician face card experience.Li Qiaofen etc. is divided into 4 types by PCOS is dialectical：Spleen emptiness and wet sputum type, controls with invigorating the spleen 25, faces
Bed observation is evident in efficacy.Must adopted chastity etc. give 60 patients with polycystic ovary syndrome kidney-nourishing Huatan Formulas and control QI invigorating, eliminating the phlegm and stimulate the menstrual flow, side
Foshousan plus-minus is closed with grey attached phlegm ball of leading；Kidney-yang deficiency type, control with warm kidney adjust punching, it is eliminating dampness and eliminating phlegm, side added and subtracted with Gui-shen pill；The stagnation of the circulation of vital energy
Phlegm retention, is controlled with dispersing stagnated hepatoqi, promoting the circulation of qi resolving sputum, side is added and subtracted with Xiaoyao San；Intermingled phlegm and blood stasis type, is controlled with promoting blood circulation and removing blood stasis, eliminating dampness and eliminating phlegm,
DANGGUI SHAOYAO SAN is closed with guizhi fuling pill and is added and subtracted in side.Sang Xia is with classical prescription Longdan Xiegan Tang plus-minus treatment Liver Channel stagnated fire type PCOS
Treat, be within 3 months 1 course for the treatment of, clinical symptoms, menstrual cycle and serum before and after 1 ~ 2 course for the treatment of, observation and treatment are treated altogether
FSH, LH, E2, T level change, and as a result serum Lh, T, LH/FSH relatively treat front lower
Drop（ P <0.01）；3 month to dates recover to pass through 51, and clinical efficacy is good.Xie Jinghong etc. uses Chinese medicine preparation
Many capsule drinks（Semen Cuscutae, the root of herbaceous peony, barrenwort, radix bupleuri etc.）PCOS kidney deficiency patients with TCM liver depression 30 is treated, it is continuous to treat 6 months effectively
Rate is 86.7%, and pregnancy rate is 62.5%, and the moon, improved effective percentage was 83.3%, and difference is respectively provided with statistical significance before and after treatment（ P
<0.05）.Liu Yun etc. has found that danzhi xiaoyao pills can improve PCOS with IR anovulatory sterility patient's ovulation rates by clinical observation
And pregnancy rate, and tcm syndrome can be significantly improved, had a clear superiority compared with single use of western medicine.Chen Hehong etc. summarizes professor Qin Yuehao and controlled
PCOS experiences are treated, according to physiological period to the patient of different syndrome type respectively from the celestial soup of five ability three, Longdan Xiegan Tand Jiawei, red Cape jasmine
Modified ease powder, Gexia Zhuyu Tang add taste, grey attached Daotan Tang plus taste, the yellow menstruation-regulating soups of three son three, by Yu Dangbao menstruation regulatings Tonga taste, peach
Red Siwu Tang adds the prescriptions such as taste to give to treat, and sets up man-made drugs' cycle, and clinical efficacy is notable.
4th, modern study
With the development of medical science, many scholars have done for the decoction for the treatment PCOS mechanisms of action and further probed into.Tao Lili
Found Deng by studying, plus-minus Longdan Xiegan Tang can obviously improve Liver Channel stagnated fire type PCOS patient's hyperandrogenism symptom and interior
Secretion situation, can be effectively improved PCOS clinical manifestation, can also correct Liver Channel stagnated fire type PCOS patient's to a certain extent
Insulin resistance condition, the thecacells pigment for pivotal role may be played in Liver Channel stagnated fire type PCOS develops
Also there is P450C17 enzymatic activitys, plus-minus Longdan Xiegan Tang dual regulation to act on, and it can be changed by reducing the activity of P450C17 enzymes
Kind hyperandrogenism, so as to play a part for the treatment of PCOS.Yu Anqi is it has also been found that soothing the liver purging intense heat Chinese medicine can obviously improve Liver Channel
Stagnated fire symptom, reduction free testosterone, androstenedione, so as to treat hyperandrogenism, can improve body peripheral tissues to pancreas islet
Plain sensitiveness, improves insulin resistance condition, reduces elevated serum leptin levels, and by improve hypothalamus-hypophysis-
The function of hypothalamic pituitary ovarium axis, reduces patient LH/FSH, LH, so as to improve ovary ovulatory dysfunction, adjusts the menstrual cycle, makes part not
Pregnant patient becomes pregnant.The research such as bright of Xu Lianwei etc., text shows invigorating kidney, promoting blood circulation, change
Stasis of blood prescription treatment PCOS can be by raising serum SHBG and reduction serum FAI, reduction androgen levels, improvement lipid
Metabolism, improvement insulin level, and achieve preferable curative effect.Zhou Lulu researchs find that invigorating the spleen to clear away damp pathogen medicine can effectively treat spleen
Empty wetness hyperactivity type Stein-Leventhal syndrome, it is possible to improve the hormonal readiness in serum, obtains the clinical symptoms and sign of patient
Improve well.Zhai Jun etc. has found that Jianpi Bushen joint melbine can obviously reduce metabolic abnormalities of obese women with obese polycystic ovary syndrome
LH, T level, improve the sensitiveness of insulin, reduce blood lipid level, reduce melbine side effect, improve patient compliance, especially
It is that improvement to blood fat is substantially better than metformin alone group.The Chinese medicine with dispelling phlegm and eliminating dampness is thought in Lin Min researchs, can reduce
Phlegm-dampness constitution patient body fat is gathered, and changes lipid-metabolism, reduces blood viscosity, improves apolipoprotein content in blood, from
And dispelling phlegm and eliminating dampness, lively atmosphere blood, the purpose of Disperse hepatic depression are reached, phlegm wet, hemostasis is gone, and qi and blood passages through which vital energy circulates is unobstructed, punching wantonly two
Arteries and veins, which is adjusted, to be reached, then the light body of body is good for, and menses can be able at present.Luo Shicun researchs also indicate that traditional Chinese medical science prescription can reduce T, FT, A, so that
Available for treatment hyperandrogenism, LH/FSH ratios are adjusted, liver kidney is nursed one's health, the menstrual cycle is adjusted, makes equilibrium between yin and yang and make portion
Infertile patient is divided to become pregnant.
5th, brief summary
In summary, for a long time the PCOS cause of disease and treat all in the exploratory development stage, it is appreciated that, in
The applying for all sides of traditional Chinese medicine cured under then instructing can substantially adjust all cards of PCOS in clinic
, but due to the Related Mechanism and effect link research for TCM Therapy are scarcely out of swaddling-clothes, in mechanism
Lack Unified Explanation in terms of elaboration.With the development of medical science, explore Chinese medicine PCOS preferred plans and verify that it is related
Mechanism by be future studies Chinese traditional treatment PCOS trend.
Medicine of the present invention is developed meticulously for many years through inventor, is mainly used in treating Stein-Leventhal syndrome.Through research
Show, medicine of the present invention has preferable therapeutic effect to Stein-Leventhal syndrome.
The Ji Yuan of bulk drug is as follows in medicine of the present invention：
Flat bamboo ginseng is Liliaceae purple bergenia rhizome platymiscium crutch purple bergenia rhizomeTofieldia divergens Bur. Et Franch.[T.yunnanensis Franch.]Herb.
Naked post chrysanthemum is naked post chrysanthemum Soliva anthemifolia (Juss.) the R. Br. of the naked post Dendranthema of composite family
The herb of [Gymnostyles anthemifolia Juss.].
The content of the invention
It is an object of the invention to provide the medicine that a kind of flat bamboo participates in naked post chrysanthemum.
It is a further object of the present invention to provide the preparation method of the medicine.
Present invention also offers the quality determining method of the medicine.
Present invention also offers the pharmaceutical applications of the medicine.
The purpose of the present invention is realized by the following manner：
A kind of medicine is made up of the raw material of following parts by weight：Flat bamboo joins 1~2 parts by weight, the naked parts by weight of post chrysanthemum 1~2.
The medicine is preferably what is be made up of the raw material of following parts by weight：Flat bamboo joins 1 parts by weight, the naked parts by weight of post chrysanthemum 2.
The medicine is preferably what is be made up of the raw material of following parts by weight：Flat bamboo joins 2 parts by weight, the naked parts by weight of post chrysanthemum 1.
The medicine is preferably what is be made up of the raw material of following parts by weight：Flat bamboo joins 1 parts by weight, the naked parts by weight of post chrysanthemum 1.
Piece agent, pill, powder, hard capsule, soft capsule, granule, oral liquid can be prepared in described medicine.
Described medicine is adopted to be prepared with the following method：Flat bamboo ginseng, naked post chrysanthemum are taken, mixing adds the water immersion of 3~15 times of amounts
0.5~2 hour, decoct 0.5~2 hour, decoct 2~4 times, 0.5~2 hour every time, extract solution merged, filtration, filtrate concentration,
Fine powder is dry, pulverize into, auxiliary material is added, mixed, loads hard shell capsules, produces.
Described medicine is preferred to use following method and prepared：Take dry flat bamboo to join, naked post chrysanthemum, for the first time plus 11 times amount water
Immersion 1 hour, is decocted 1 hour, is added 4 times of amount decoctings to boil for the second time 1 hour, is merged decocting liquid, filtration, filtrate concentrates, dry, powder
Fine powder is broken into, is sieved, is mixed, loads hard shell capsules, produces.
Described medicine is adopted to be detected with the following method：Containing for sweet-scented osmanthus olive glycosides dimethyl esters is carried out using high performance liquid chromatography
It is fixed to measure：
（1）Chromatographic condition：Using HypersilDs chromatographic columns；Mobile phase：Ratio is 20~40：60~80 acetonitrile-water；
Detection wavelength：190~210nm；Column temperature：15~25 DEG C；Flow velocity：0.5~1.5mLmin-1；Sample size：5~20 μ L；
（2）It is prepared by reference substance solution：Precision weighs the dry sweet-scented osmanthus olive glycosides dimethyl esters reference substance to constant weight in right amount, plus first
Reference substance solution is made in alcohol dissolving；
（3）The preparation of need testing solution：Precision weighs medicine of the present invention, plus methanol, is heated to reflux, extract solution reflux solvent
And be concentrated to dryness, residue is dissolved in water, and is shaken and extracted with water saturated n-butanol, merges n-butanol extracting liquid, is washed with ammonia solution
Wash, n-butanol extracting liquid recycling design is to doing, and residue adds methanol to dissolve, and shakes up, filtration takes filtrate, produces need testing solution；
（4）Determine：Precision measures each 5~20 μ L of above-mentioned need testing solution, reference substance solution respectively, injects high-efficient liquid phase color
Spectrometer, is detected.
Described medicine is preferred to use following method detection：Sweet-scented osmanthus olive glycosides dimethyl esters are carried out using high performance liquid chromatography
Assay：
（1）Chromatographic condition：Using HypersilDs chromatographic columns；Mobile phase：Ratio is 30：70 acetonitrile-water；Detect ripple
It is long：200nm；Column temperature：20℃；Flow velocity：1.0mL·min-1；Sample size：10μL；
（2）It is prepared by reference substance solution：It is appropriate to the sweet-scented osmanthus olive glycosides dimethyl esters reference substance of constant weight that precision weighs 80 DEG C of dryings,
Plus reference substance solutions of every 1mL containing 0.2mg is made in methanol dissolving；
（3）The preparation of need testing solution：Precision weighs medicine 10g of the present invention, plus methanol 40mL, is heated to reflux 4h, extracts
Liquid reflux solvent is simultaneously concentrated to dryness, residue add water 10mL dissolving, with water saturated n-butanol shaking extract 5 times, each 20mL, close
And n-butanol extracting liquid, washed with ammonia solution 3 times, each 15mL, n-butanol extracting liquid recycling design is to doing, and residue adds methanol molten
Solve and be transferred in 10mL volumetric flasks, plus methanol is to scale, shakes up, filtration, takes filtrate, produces need testing solution；
（4）Determine：Precision measures each 10 μ L of above-mentioned need testing solution, reference substance solution respectively, injects high performance liquid chromatography
Instrument, is detected.
Described medicine can be used for preparing treatment Stein-Leventhal syndrome, the medicine or health products of ovarian cyst.
Experiment one：Influence of the medicine of the present invention to Model of Polycystic Ovarian Syndrome rat
This experimental study prepares rats with polycystic ovary syndrome model using progestational hormone and HCG joint molding methods, compares use
Hormone serum level changes before and after medicine, to provide experimental data and effect prescription for traditional Chinese medical herbal treatment PCOS.
1 experiment material
1.1 experimental animals
24d ages teenage SD female rats, 30 ~ 40g of body weight is provided by Heilongjiang University of Chinese Medicine's Experimental Animal Center.
1.2 medicines and reagent
Medicine of the present invention：Prepared according to the embodiment 1 in description of the invention embodiment；
Drugs compared first：Prepared according to the embodiment 2 in description of the invention embodiment；
Drugs compared second：Prepared according to the embodiment 3 in description of the invention embodiment；
Melbine：With distillation water dissolves, after being converted by people mouse weight ratio, it is administered with 0.018g/d dosage.
Kit：Beijing North great achievement Development Co., Ltd, lot number：RT110371.
2 experimental methods
2.1 experiment packets
60 rats are randomly divided into medication therapy groups of the present invention, drugs compared first group, drugs compared second group, melbine
Control group, model control group and negative control group, totally 6 groups, every group of 10 rats.
2.2 experimental methods
1 hypodermic injection of 0.5mg LNGs day, is subcutaneously noted for 2 times at 27d ages, plus with HCG 1.5IU days
Penetrate, co-injection 21d.
After modeling success,（1）Medicine group of the present invention：Give medicine 1.8g/d of the present invention；（2）Drugs compared first group：Give
Drugs compared first 1.8g/d；（3）Drugs compared second group：Give drugs compared second 1.8g/d；（4）Melbine group：Give diformazan
Biguanides 0.018g/d.Gavage that one time a day, successive administration 15d.
3 experimental results
FSH, LH, T Concentration Testing result, are shown in Table 1-l in each group animal blood serum.The blood of negative control group and model control group
There were significant differences for clear FSH, LH and T content（P<0.05）, point out modeling success.
After treatment, there was no significant difference for the content of serum FSH, LH and T in medicine group and negative control group of the present invention（P>
0.05）, point out drug therapy of the present invention to influence FSH, LH and T level of PCOS patient, be close to normally, and contrast
The effect of medicine first group and drugs compared second group is not then good.
FSH, LH, T concentration in table 1-1 each group animal blood serums（±S）
Note：Compared with model control group, #P<0.05, ##P<0.01；Compared with negative control group, ☆ P>0.05.
4 discuss
Stein-Leventhal syndrome clinical manifestation is in the endocrinic syndrome of polymorphism, with Hyperandrogenism and chronic anovulation
It is to cause one of most common reason of women at fertile age paramenia for clinical principal character.Its generally acknowledged pathologic, physiologic feature
It is：Androgen generation is excessive, and high LH is with normal or low-level FSH, hyperinsulinemia-insulin resistance.Polycystic ovary
The LH and T of syndrome rat model are substantially compared with negative control group rise, and FSH is slightly lower, is because patients with polycystic ovary syndrome
Hypophysis to GnRH sensitiveness increase, secretion excess LH and ovary in as androgen formed enzyme cytochromes
（cytochromep-450c17）Functional disturbance, cause stroma of ovary, thecacells produce excessive androgens.It is high in ovary
Androgen suppresses follicle maturity, causes developmental follicle atresia, it is impossible to form dominant follicle, so that the normal secretions of estrogen
Interrupt, but many small ovarian follicles still secrete estrogen.The certain level of the small ovarian follicle secretion of oestrone and ovary of continuous release
Estradiol act on hypothalamus and hypophysis, be in positive feedback to LH secretion, LH is secreted amplitude and frequency increase, LH is in continuing
High level, and the horizontal relative reductions of FSH.
5 conclusions
Medicine of the present invention may interfere with the hormonal readiness of patients with polycystic ovary syndrome, so as to reach the healing sick purpose.
Particularly, the action effect of medicine of the present invention is substantially better than drugs compared first and drugs compared second, illustrates two in medicine of the present invention
The compatibility planted between flavour of a drug is superior, and indispensable, the combination between two kinds of flavour of a drug generates obvious synergistic function, produces
One-plus-one is more than two technique effect.
Experiment two：The effect observation of 40 Stein-Leventhal syndromes of drug therapy of the present invention
Conventional doctor trained in Western medicine Stein-Leventhal syndrome（PCOS）Treatment mainly by the way of oral promoting ovulation drug, but with
The extension of administration time, the phenomenon that patient difficult gestation occurs, easily miscarried.In recent years, operative treatment, laparoscope have clinically been carried out
The modes such as Ovarian electrocoagulation drilling, Effect value must be affirmed, but the wound caused to women is also very big.Researcher applies medicine of the present invention
Thing is treated to PCOS patient, achieves good effect.Now report as follows.
1. data and method
1.1 clinical datas
The patients with polycystic ovary syndrome 75 gone to a doctor during in March, 2015 to 2 months 2016 in our hospital, meets《Woman
Obstetrics》In about Stein-Leventhal syndrome diagnostic criteria.Primary symptom：, there is oligomenorrhea in menoxenia or amenorrhoea is infertile；It is real
Test room inspection：Interstitialcellstimulating hormone (ICSH)（LH）/ FSH（FSH）The Hes of ＞ 3（Or）Testosterone（T）＞ 2.2nmol/L and（Or）
Androstenedione（A）＞ 9.0nmol/L.Ultrasound diagnosis：Side or bilateral ovaries increase, polycystic change.
Rejecting standard：1. male sex hormone caused by other endocrine system diseases is raised；2. infertility caused by other factors；③
The patient of insanity or cognition dysfunction；4. the endocrine medicine of influence or contraceptive person were taken within nearly 3 months；5. merge
The organic diseases such as severe cardiac, kidney, liver.
23~36 years old age, the course of disease 1~8 year.Wherein menstrual disorder 61, infertile person 58, overweight people 31.
It is different according to treatment method, it is divided into observation group and control group, control group 35, observation group 40.2 groups of patients year
Age, the course of disease compare no significant difference（P ＞ 0.05）, with comparativity.
1.2 treatment methods
Control group uses regular western medicine treatment antisterone piece 40mg, 2 times/d, successive administration 20d.Diformin tablet
0.5g, 3 times/d, is discontinued during to normal ovulating.Clomiphene capsule 50mg/d, is used in conjunction 5d.Vitamin C 200mg, 3 times/d, connects
Use 20d.
Observation group adds on the basis of control group uses medicine of the present invention（With reference in description of the invention embodiment
It is prepared by embodiment 4）, 2 every time, 2 times a day, point takes for 2 times sooner or later.From the menstrual cycle 7th, 3d is continuously taken, is discontinued
1d.3 menstrual cycles of the course for the treatment of.
1.3 observation index
Treat 2 groups of patient clinical symptom changes of fore-and-aft observing, laboratory examination follicular stimulating hormone（FSH）, lutropin
（LH）, testosterone（T）Level changes.
Ultrasound diagnosis ovary becomes with uterine blood flow：
RI=（Peak systolic velocity-blood flow speed at the end of vasodilation）/ peak systolic velocity；
PI=（Minimum VPV in peak systolic velocity-cardiac cycle）The time of/peak veloity,PV puts down
Average.
1.4 efficacy assessment standards
With reference to the Ministry of Public Health《New Chinese medicine guideline of clinical investigations》The standard of middle Stein-Leventhal syndrome：
Recovery from illness：Continuous 3 months menstruation recovery normal cycles after drug withdrawal, menstrual period, blood volume are normal, recover normal ovulation, BBT
Two-phase or gestation, tcm syndrome therapeutic index >=90%；
It is effective：Menstruation is close to normal cycle after treatment（Within 40d）, blood volume is normal, 8~10d of menstrual period, in 90% ＞
Cure therapeutic effect of syndrome index >=66.67%；
Effectively：Menstrual onset 1 time in 3 months is treated, blood volume, menstrual period are relatively treated in preceding improvement in various degree, 66.67% ＞
Cure therapeutic effect of syndrome index >=33.33%；
It is invalid：Continuous treatment 3 months, the menstrual cycle has no improvement, tcm syndrome therapeutic index ＜ 33.33%.
1.5 statistical methods
Statistical analysis is carried out to data using the statistical softwares of SPSS 15.0, enumeration data and measurement data are respectively adopted
χ2Examine, t is examined.There is statistical significance for difference with P ＜ 0.05.
2 results
2.1 2 groups of patient's comparitive studies
Observation group's treatment total effective rate is 92.5%, and control group total effective rate is 71.4%, and difference has statistics
Meaning（χ2=5.784, P ＜ 0.01）, it is shown in Table 2-1.
The therapeutic effect contrast of 2 groups of patients with polycystic ovary syndrome of table 2-1（Example）
Ovulation induction, recovery ovulation, Pregnancy compare after 2.2 2 groups of patient's treatments
Observation group's follicle maturity rate, recovery ovulation, pregnancy rate are significantly better than control group（χ2=9.099,6.857,
12.538, P ＜ 0.01）, it is shown in Table 2-2.
Ovulation induction, Pregnancy compare ［ example after 2 groups of patients with polycystic ovary syndrome treatments of table 2-2（%）
Hormonal readiness change before and after 2.3 treatments
Compared with pre-treatment, LH, T and LH/FSH decrease before relatively treating.After treatment, each hormonal readiness phase between group
It is more statistically significant than difference（T=5.324,6.254,3.413,13.580, P ＜ 0.05）, it is shown in Table 2-3.
The change of hormonal readiness before and after 2 groups of patients with polycystic ovary syndrome treatments of table 2-3
3 discuss and conclusion
Saying for " Stein-Leventhal syndrome " is had no in traditional medicine, it is subordinate to models such as " amenorrhoea " " delayed menstrual cycle " " infertile "
Farmland.The traditional Chinese medical science thinks that " going out all kidneys through water ", i.e. kidney are store essential substances part, are the essential conditions that feminine menstrual is risen.Deficiency of kidney-QI, it is empty
Tremble with fear stagnant blood be this disease this, qi and blood phlegm it is turbid for and press from both sides the interpretation of the cause, onset and process of an illness.Kidney deficiency can not rising lower burnt body fluid, it is insufficiency of the spleen to be unable to transmitting and distributing the fluids, Tianjin
Liquid water is wet poly- into phlegm, and kidney deficiency phlegm wet is mingled with, and mutually damages negative and positive."-uterus is appointed in kidney-day decyl- punching " Reproductive Axis dysfunction is then induced,
That is PCOS.
Egg cell grows by hormone regulating and controllings such as FSH, LH.FSH acts on ovary, promotes developing into for primordial follicle
It is ripe.When FSH concentration is not enough in liquor folliculi, mitosis is obstructed, and ovarian follicle can not continue development.There is research to point out, FSH levels exist
It is most important in the selection of dominant follicle.LH is the characteristic change that PCOS patient labs check extremely, is also reproduction work(
The basic reason of energy obstacle.Too high LH can promote thecacells, interstitial cell to produce a large amount of androgens in vivo, and convert
For oestrone.Oestrone can upset the formation at LH peaks in the menstrual cycle, the maturation of influence ovarian follicle and discharge.This research display, observation group
LH/FSH ratios after treatment are significantly reduced, and T hormonal readinesses decline, and contribute to development and the increase intrauterine of graaffian follicle
The growth of film.Prompting, medicine of the present invention can warming and invigorating kidney Yang, increase Progesterone Secretion, strengthen luteal function, irregular menstrual rises,
Good environment is built for Embryo implantation.Kidney yin must be supported, and kidney yang must be changed, and benefiting essence-blood is appointed originally with Gu Chong, therefore essential substance for reproduction is abundant.
Data display, observation group's treatment total effective rate is 92.5%, and simple western medicine only 71.4%.In addition, observation group's recovery ovulation situation,
Pregnancy rate is significantly better than control group, that is to say, that medicine of the present invention is ovulated to PCOS patient, gestation is beneficial.
Experiment three：The experimental study of drug therapy ovarian cyst of the present invention
Ovarian cyst（OvarianCyst, OC）It is one of common benign tumour of modern gynaecology, accounts for ovarian neoplasm
75%.It refers to generation Cystic lesions inside ovary, can be divided into Non-cancerous and the class of tumprigenicity two, be equal to traditional Chinese medical science " Disorder lumps in the abdomen " " product
It is poly- " category of the disease such as " ovarian cyst ", the young women for being mainly in 20~50 years old, the incidence of disease accounts for the 15% of the women of child-bearing age.Researcher
OC basic pathogenesis and principle of reatment is inquired into tcm theory, it is believed that the disease is more to be adjusted because women ignores in menstrual period or postpartum
Reason, because being invaded in the heresy of inernal injuries caused by seven emotions or the six external factors which cause diseases, visceral dysfunction causes raw in wet turbid phlegm and retained fluid, stagnation of blood stasis vessels of the uterus accumulates day
Form tumour long.Its interpretation of the cause, onset and process of an illness core is stagnation of liver-QI with deficiency of the spleen, phlegm and blood stasis.Treat suitable invigorating spleen and soothing liver, dampness removing resolving sputum, blood circulation promoting and dispersing pathogen accumulation.
Medicine of the present invention has extraordinary therapeutic effect, researcher's prediction, medicine of the present invention to Stein-Leventhal syndrome
Should also have certain therapeutic effect to ovarian cyst, then just carry out trial row experimental study, observe medicine of the present invention
To interleukin-6 in OC rat model blood（IL-6）, estradiol（E2）, progesterone（P）Content influence.
1 material
1.1 experimental animals
SPF grades of healthy adult female wistar rats 75, two monthly ages, body weight（200±10）G, experimental animal is by black dragon
River university of TCM Experimental Animal Center is provided.
1.2 medicines and preparation
Medicine of the present invention：Prepared with reference to the embodiment 1 in description of the invention embodiment.Every milli is condensed into respectively
Two kinds of decoctions containing crude drug 1,2g are risen, low dose group and high dose group is used as.Put 4 DEG C of preservations in refrigerator.
Positive control drug：Guizhi fuling pill（Shanxi poplar Wenshui pharmaceutical Co. Ltd, Chinese medicines quasi-word Z14020791）, per ball
Weight 6g.
1.3 main agents
10% chloraldurate, 10% mustard oil, paraffin oil, injection physiological saline, medical Iodophor.Operating theater instruments is a set of（Hand
Art knife, big staight scissors, big curved scissors, tissue clamps, ophthalmic tweezers, haemostatic clamp, suture needlework, sterile cotton balls, medical gloves, disposable note
Emitter etc.）.
1.4 main equipment
Full-automatic chemiluminescence apparatus, ADVIAXP（Siemens）；Sex hormone kit（Biology is built up in Nanjing to be had
Limit company）；Rat, IL-6ELISA, ERC003（Xin Bosheng bio tech ltd）；Freezing microtome, Finesse325（English
Three bio tech ltd of state）；Assay balance, BS110S（Beijing Sai Duolisi balances Co., Ltd）；White mouse full set cage
Frame（Suzhou Han Shan metal product plants）.
2 methods
2.1 experiment packets
Animal is randomly divided into 5 groups, every group 15.Respectively normal group, model group, guizhi fuling pill group, medicine of the present invention
Low dose group, medicine high dose group of the present invention.
2.2 modeling methods
With reference to Wesselmann（Refined loyal practicalities gynecotokology [M] the Beijing of king:People's Health Publisher, 2000:707）Cause
Standby rat " ovarian cyst " model, using 10% chloraldurate abdominal cavity（0.35/100g）After injecting anesthetic, it is in dorsal position to make rat,
It is fixed on autopsy table, Ventral Midline shaves off mouse hair and routine disinfection, and cutting for 1.5cm length and vertical direction is made in Ventral Midline
Mouthful, it is pubic symphysis, here chorista and the cellulite of wrapping at the 0.5cm of otch lower end top, through being found on rear side of bladder
Fallopian tubal, left ovary is found out along ampulla of uterine tube, by 0.1mL10% mustard oil（95% mustard oil is dilute with paraffin oil
Release）Ovary is injected, is sealed with soft wax by pinprick is injected, prevents overflow of drug fluid.Layering suture operation otch, terminal disinfection otch,
White mouse is put back in cage.The acute congestion oedema of internal organs can be caused after general injection mustard oil 2h, inflammatory reaction occurs and forms capsule
It is swollen.Rats with left ovary is won after injection 2h, after fixing 48h, alcohol serial dehydration through 10% formaldehyde, 15 μm of frost is carried out
Microsection manufacture, carries out HE dyeing.In the form of two groups of ovaries of low power Microscopic observation, it can be seen that the ovary of rat after injection mustard oil
Obvious congested, oedema.With ovarian cyst>10mm is modeling success.
2.3 medications
Modeling success each group is randomly assigned to complete to start administration.Medicine high dose group of the present invention, low dose of medicine of the present invention
Amount group gavages medicine decocting liquid of the present invention respectively, is respectively equivalent to 50gkg containing crude drug-1·d-1And 25gkg-1·d-1；Cassia twig
Fuling pill group gavages the guizhi fuling pill suspension of isometric(al)；Normal group and model group are filled with the physiological saline of isometric(al).Each group
Press 0.25mL10g-1·d-1Gavage.1 time/d, continuous 6 weeks.
2.4 method of drawing material
After the completion of packet, i.e., rat tail is taken into blood, be put into the clear EP pipes of mark.Gavage uses same sample prescription after 6 weeks
Method takes blood.To determine after every group of before processing IL-6 and sex hormone in rat blood（Estradiol, progesterone）Content.
2.5 statistical procedures
Measured data are analyzed using statistic software SPSS 13.0, and measurement data is used（sx±）Statistics is carried out to retouch
State.After homogeneity test of variance, variance F analyses are carried out between each group.Compare between group and examined with t, P<0.05 expression difference has
Statistical significance.
3 results
Compared with Normal group, IL-6 and sex hormone in model group（Estradiol, progesterone）Content it is significantly raised, see
Table 3-1.
IL-6, estradiol, the content of progesterone in the preceding each group rat blood serum of table 3-1 treatments
After medicine of the present invention and Guizhi Fuling Pills in Treating, it was observed that IL-6, estradiol, progesterone are in guizhi fuling pill group
Rat blood in content decrease（P<0.05）, and IL-6, estradiol, progesterone medicine high dose group of the present invention,
The content in rat blood in medicine low dose group of the present invention is not substantially reduced（P ＞ 0.05）, it is shown in Table 3-2.
IL-6, estradiol, the content of progesterone in each group rat blood serum after table 3-2 treatments
4 conclusions
This experimental study shows that medicine of the present invention can not reduce IL-6 level, it is impossible to suppress local fibroblasts increasing
Raw, fibrin formation and collagen deposition, can not mitigate the inflammatory adhesion of ovarian cyst focus and fibrosis, to ovarian cyst
No inhibitory action is grown, so, drugs on ovarian tumour of the present invention is without therapeutic action, it is impossible to make tumour atrophy.
Experiment four：The quality determining method research of medicine of the present invention
1 instrument and reagent
1.1 instruments
High performance liquid chromatograph（Agilent110 high performance liquid chromatographs and work station, G1311Aquat pumps, G1314 are purple
External detector）.
1.2 reagents
Sweet-scented osmanthus olive glycosides dimethyl esters reference substance（Chinese pharmaceutical biological product examines and determine research institute）；Chinese medicine composition of the present invention；
Chinese medicine（The Harbin Pharmaceutical Group people provide with safe chain pharmacy）；Methanol（Chromatogram alcohol, Shanghai biochemistry work auxiliary reagent factory）；Other reagents are
Analysis is pure.
2 methods and result
2.1 prescriptions
Flat bamboo joins 500g, naked post chrysanthemum 500g.
2.2 prepare
Take dry flat bamboo to join 500g, naked post chrysanthemum 500g, add 11000mL water to soak for the first time 1 hour, decoct 1 hour, the
Secondary plus 4000mL, is decocted 1 hour, merges decocting liquid, and filtration, filtrate concentration is dried, produced.
The assay of 2.3 sweet-scented osmanthus olive glycosides dimethyl esters
2.3.1 HPLC chromatogram condition
Using HypersilDs（4.0mm × 125mm, 5 μm）Chromatographic column；Mobile phase：Ratio is 30：70 acetonitrile-water；Inspection
Survey wavelength：200nm；Column temperature：20℃；Flow velocity：1.0mL·min-1；Sample size：10μL；Under the chromatographic condition, reference substance and sample
Product chromatographic peak is good, and it is noiseless to determining to join negative control without flat bamboo.
2.3.2 the preparation of reference substance solution
It is appropriate to the sweet-scented osmanthus olive glycosides dimethyl esters reference substance of constant weight that precision weighs 80 DEG C of dryings, plus methanol is made every 1mL and contained
0.2mg solution.
2.3.3 the preparation of need testing solution and negative controls
Precision weighs medicine 10g of the present invention, plus methanol 40mL, is heated to reflux 4h, and extract solution reflux solvent is simultaneously concentrated to dryness,
Residue add water 10mL dissolving, with water saturated n-butanol shaking extract 5 times, each 20mL, merge n-butanol extracting liquid, tried with ammonia
Liquid is washed 3 times, each 15mL, and n-butanol extracting liquid recycling design is to doing, and residue adds methanol to dissolve and is transferred to 10mL volumetric flasks
In, plus methanol is to scale, shakes up, filtration, takes filtrate to produce；It is another that the negative controls joined without flat bamboo are prepared in prescription ratio,
It is made in the same way of negative controls.
2.3.4 the drafting of standard curve
It is appropriate to the sweet-scented osmanthus olive glycosides dimethyl esters reference substance of constant weight that precision weighs 80 DEG C of dryings, and 10.4 are made with methanol,
20.8,41.6,83.2,166.4 μ gmL-1The solution of series concentration, respectively precision measure above-mentioned each 10 μ L of 5 kinds of strength solutions, note
Enter high performance liquid chromatograph to be measured.
Linear regression is carried out with peak area ratio and concentration, obtaining regression equation is：A=21.2763C-0.1391, r=
0.9999.Show sweet-scented osmanthus olive glycosides dimethyl esters in 10.4~166.4 μ gmL-1It is in good linear relationship in concentration range.
2.3.5 stability test
Precision draws the μ L of need testing solution 10, respectively at 0,1,2,4,8h sample introduction, and calculates sweet-scented osmanthus olive glycosides dimethyl esters and contain
Amount.As a result RSD is 0.45% in 8h（n=5）.Show that sample solution is stable in 8h.
2.3.6 replica test
By 5 parts of need testing solution preparation method parallel processing sample, sweet-scented osmanthus olive glycosides dimethyl esters content is determined in accordance with the law and is counted
Calculate.As a result sweet-scented osmanthus olive glycosides dimethyl esters average content is measured for 0.12mgg-1, RSD is 1.3%.
2.3.7 Precision Experiment
Precision draws sweet-scented osmanthus olive glycosides dimethyl esters reference substance solution, repeats sample introduction 5 times, and peak area is determined in accordance with the law.As a result RSD
For 0.23%（n=5）.Show that precision is preferable.
2.3.8 the rate of recovery is tested
Precision weighs 6 parts of the sample of the same lot number of known sweet-scented osmanthus olive glycosides dimethyl esters content, by high, medium and low concentration point
It is inaccurate to add appropriate sweet-scented osmanthus olive glycosides dimethyl esters reference substance solution, determine and operated under item by sample, determine, calculate back in accordance with the law
Yield.As a result average recovery rate is 0.45% for 100.3%, RSD（n=5）.
2.3.9 sample size is determined
Reference substance solution and appropriate need testing solution are measured respectively, are filtered with miillpore filter, each μ L of sample introduction 10, by above-mentioned color
Spectral condition determines 3 batches of samples, parallel determination 5 times.By external standard method with calculated by peak area need testing solution sweet-scented osmanthus olive glycosides dimethyl esters
Content.This product olive containing sweet-scented osmanthus glycosides dimethyl esters should be the 95%~105% of sign content, with every 1g samples glycosides diformazan of olive containing sweet-scented osmanthus
Base ester meter, must not be less than 0.12mg.3 batches of sample sizes are respectively 100.8%（RSD=1.2%）, 101.7%（RSD=1.3%）,
99.2%（RSD=1.1%）.
Embodiment：
Embodiment 1：Medicine of the present invention
Prescription：Flat bamboo joins 50g, naked post chrysanthemum 50g
Preparation method：Take dry flat bamboo to join 50g, naked post chrysanthemum 50g adds 1100mL water to soak 1 hour for the first time, decocts 1 small
When, second plus 400mL, decoct 1 hour, merge decocting liquid, filtration, filtrate concentration is dried, obtains medicine of the present invention.
Embodiment 2：Drugs compared first
Prescription：Flat bamboo joins 100g
Preparation method：Take dry flat bamboo to join 100g, add 1100mL water to soak for the first time 1 hour, decoct 1 hour, second
Secondary plus 400mL, is decocted 1 hour, merges decocting liquid, and filtration, filtrate concentration is dried, obtains drugs compared first.
Embodiment 3：Drugs compared second
Prescription：Naked post chrysanthemum 100g
Preparation method：Dry naked post chrysanthemum 100g is taken, adds 1100mL water to soak for the first time 1 hour, decocts 1 hour, second
Secondary plus 400mL, is decocted 1 hour, merges decocting liquid, and filtration, filtrate concentration is dried, obtains drugs compared second.
Embodiment 4：Pharmaceutical hard capsule agent of the present invention
Drug prescription：Flat bamboo joins 500g, naked post chrysanthemum 500g
Preparation method：Take dry flat bamboo to join 500g, naked post chrysanthemum 500g, add 11000mL water to soak for the first time 1 hour, decoct
Boil 1 hour, second plus 4000mL, decoct 1 hour, merge decocting liquid, filtration, filtrate concentration dry, pulverize into fine powder, plus
Enter auxiliary material, mix, load hard shell capsules, be made 1000..
Assay is carried out to sweet-scented osmanthus olive glycosides dimethyl esters using high performance liquid chromatography：
（1）Chromatographic condition：Using HypersilDs chromatographic columns；Mobile phase：Ratio is 30：70 acetonitrile-water；Detect ripple
It is long：200nm；Column temperature：20℃；Flow velocity：1.0mL·min-1；Sample size：10μL；
（2）It is prepared by reference substance solution：It is appropriate to the sweet-scented osmanthus olive glycosides dimethyl esters reference substance of constant weight that precision weighs 80 DEG C of dryings,
Plus solution of every 1mL containing 0.2mg is made in methanol；
（3）The preparation of need testing solution：Precision weighs medicine 10g of the present invention, plus methanol 40mL, is heated to reflux 4h, extracts
Liquid reflux solvent is simultaneously concentrated to dryness, residue add water 10mL dissolving, with water saturated n-butanol shaking extract 5 times, each 20mL, close
And n-butanol extracting liquid, washed with ammonia solution 3 times, each 15mL, n-butanol extracting liquid recycling design is to doing, and residue adds methanol molten
Solve and be transferred in 10mL volumetric flasks, plus methanol is to scale, shakes up, filtration, takes filtrate, produces need testing solution；
（4）Determine：Precision measures each 10 μ L of above-mentioned need testing solution, reference substance solution respectively, injects high performance liquid chromatography
Instrument, is detected, testing result is that the content of sweet-scented osmanthus olive glycosides dimethyl esters is 0.1823mg/g.
Moreover, it will be appreciated that although the present specification is described in terms of embodiments, not each embodiment is only wrapped
Containing an independent technical scheme, this narrating mode of specification is only that for clarity, those skilled in the art should
Using specification as an entirety, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
It may be appreciated other embodiment.
Claims (6)
1. a kind of medicine for treating Stein-Leventhal syndrome, it is characterised in that the medicine is made up of the raw material of following parts by weight
's：Flat bamboo joins 1 parts by weight, the naked parts by weight of post chrysanthemum 1.
2. medicine as claimed in claim 1, it is characterised in that the medicine preparation piece agent, pill, powder, hard capsule, soft
Capsule, granule, oral liquid.
3. medicine as claimed in claim 2, it is characterised in that the medicine is adopted to be prepared with the following method：Take flat bamboo ginseng, naked post
Chrysanthemum, mixing, the water for adding 3~15 times of amounts soak 0.5~2 hour, decoct 0.5~2 hour, decoct 2~4 times, every time 0.5~2
Hour, extract solution merges, filtration, filtrate concentration, dry, pulverize into fine powder, adds auxiliary material, mix, loads hard shell capsules, produce.
4. medicine as claimed in claim 3, it is characterised in that the medicine is adopted to be prepared with the following method：Take dry flat bamboo to join,
Naked post chrysanthemum, first time adds 11 times of amount water to soak 1 hour, decocts 1 hour, adds 4 times of amount decoctings to boil for the second time 1 hour, merges decocting
Liquid, filtration, filtrate concentration dry, pulverize into fine powder, sieve, mix, loads hard shell capsules, produce.
5. a kind of quality determining method of medicine, the medicine is made up of the raw material of following parts by weight：Flat bamboo joins 1 parts by weight,
The naked parts by weight of post chrysanthemum 1, it is characterised in that the medicine is adopted to be detected with the following method：Sweet-scented osmanthus olive is carried out using high performance liquid chromatography
The assay of glycosides dimethyl esters：
（1）Chromatographic condition：Using HypersilDs chromatographic columns；Mobile phase：Ratio is 20~40：60~80 acetonitrile-water；Detection
Wavelength：190~210nm；Column temperature：15~25 DEG C；Flow velocity：0.5~1.5mLmin-1；Sample size：5~20 μ L；
（2）It is prepared by reference substance solution：Precision weighs the dry sweet-scented osmanthus olive glycosides dimethyl esters reference substance to constant weight in right amount, plus methanol is molten
Reference substance solution is made in solution；
（3）The preparation of need testing solution：Precision weighs medicine, plus methanol, is heated to reflux, and extract solution reflux solvent is simultaneously concentrated into
Dry, residue is dissolved in water, and is shaken and extracted with water saturated n-butanol, merges n-butanol extracting liquid, is washed with ammonia solution, n-butanol
Extract solution recycling design is to doing, and residue adds methanol to dissolve, and shakes up, and filtration takes filtrate, produces need testing solution；
（4）Determine：Precision measures each 5~20 μ L of above-mentioned need testing solution, reference substance solution respectively, injects high performance liquid chromatography
Instrument, is detected.
6. the quality determining method of medicine as claimed in claim 5, the medicine is made up of the raw material of following parts by weight：Flat bamboo
Join 1 parts by weight, the naked parts by weight of post chrysanthemum 1, it is characterised in that the medicine is adopted to be detected with the following method：Using high performance liquid chromatography
Carry out the assay of sweet-scented osmanthus olive glycosides dimethyl esters：
（1）Chromatographic condition：Using HypersilDs chromatographic columns；Mobile phase：Ratio is 30：70 acetonitrile-water；Detection wavelength：
200nm；Column temperature：20℃；Flow velocity：1.0mL·min-1；Sample size：10μL；
（2）It is prepared by reference substance solution：It is appropriate to the sweet-scented osmanthus olive glycosides dimethyl esters reference substance of constant weight that precision weighs 80 DEG C of dryings, plus first
Reference substance solutions of every 1mL containing 0.2mg is made in alcohol dissolving；
（3）The preparation of need testing solution：Precision weighs medicine 10g, plus methanol 40mL, is heated to reflux 4h, extract solution reflux solvent
And be concentrated to dryness, residue add water 10mL dissolving, with water saturated n-butanol shaking extract 5 times, each 20mL, merge n-butanol carry
Liquid is taken, is washed with ammonia solution 3 times, each 15mL, n-butanol extracting liquid recycling design is to doing, and residue adds methanol to dissolve and be transferred to
In 10mL volumetric flasks, plus methanol is to scale, shakes up, filtration, takes filtrate, produces need testing solution；
（4）Determine：Precision measures each 10 μ L of above-mentioned need testing solution, reference substance solution respectively, injects high performance liquid chromatograph, enters
Row detection.
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| CN105796782A (en) * | 2016-05-31 | 2016-07-27 | 彭艳 | Traditional Chinese medicine composition for preventing and/or treating polycystic ovarian syndrome and preparation method and application thereof |
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| CN105796782A (en) * | 2016-05-31 | 2016-07-27 | 彭艳 | Traditional Chinese medicine composition for preventing and/or treating polycystic ovarian syndrome and preparation method and application thereof |
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| Title |
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| 多囊卵巢综合征辨治体会;王杰等;《中国中医药信息杂志》;20150228;第22卷(第2期);第98页左栏第1段以及第99页左栏倒数第2段 * |
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Effective date of registration: 20180131 Address after: 150040 Heping Road, Xiangfang District, Heilongjiang, Harbin, China, 24 Patentee after: Heilongjiang University of Chinese Medicine Address before: 154007 clinical discipline of Jiamusi college, Heilongjiang University Of Chinese Medicine, Guanghua Street, Jiamusi, Jiamusi, Heilongjiang Patentee before: Zhou Yanli |
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