CN105943658A

CN105943658A - Medicine for treating polycystic ovarian syndrome, as well as preparation method and application thereof

Info

Publication number: CN105943658A
Application number: CN201610476727.6A
Authority: CN
Inventors: 张多加
Original assignee: First Affiliated Hospital Heilongjiang University Of Chinese Medicine
Current assignee: First Affiliated Hospital Heilongjiang University Of Chinese Medicine
Priority date: 2016-06-27
Filing date: 2016-06-27
Publication date: 2016-09-21
Anticipated expiration: 2036-06-27
Also published as: CN105943658B

Abstract

The invention relates to the field of traditional Chinese medicines, and particularly relates to a medicine for treating polycystic ovarian syndrome, as well as a preparation method and application thereof. The medicine is prepared from the following raw materials in parts by weight: 1-2 parts of rosa bella rehd and 1-2 parts of berberis amurensis. The medicine can be prepared into tablets, pills, powder, hard capsules, soft capsules, granules and oral solution. The preparation method comprises the following steps: soaking dried rosa bella rehd and berberis amurensis in water which is 11 times amount of the medicinal materials for 1 hour for the first time, and decocting for 1 hour; adding 4 times amount of water for the second time, and decocting for 1 hour; and mixing decoctions, filtering, concentrating filtrate, drying, grinding into fine powder, screening, uniformly mixing and filling hard capsules. According to the chromatographic condition of the drug quality detection method, HypersilDs chromatographic column is adopted, the mobile phase is acetonitrile-water in a proportion of 30:70, the detection wavelength is 200nm, the column temperature is 20 DEG C, the flow velocity is 1.0mL.min<-1>, and the sample size is 10mu L.

Description

A kind of medicine treating polycystic ovarian syndrome and preparation method thereof and purposes

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind of Rosa bella Rehd et wils and the active medicine of yellow calamite and preparation side thereof Method.

Background technology

Polycystic ovarian syndrome (PCOS) 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.PCOS sickness rate in Female in child bearing period is up to 6% ~ 10%.There are some researches show, have 75% fertility, the amenorrhea of 26% ~ 37%, 87% ~ 90% hypomenorrhea all may be with PCOS is relevant.For the treatment of PCOS, how improving ovulation rate, pregnancy rate and gestation is problem in the urgent need to address, is also In place of the difficult point for the treatment of primary disease, in recent years, Chinese medicine PCOS, from entirety, uses differential diagnosis of diseases and the dialectical method combined Carry out diagnosis and treatment, achieve the goodst clinical effectiveness.

1 etiology and pathogenesis research

PCOS is clinical, and with androgen, too much and chronic anovulation is as principal character, show as hypomenorrhea even amenorrhea, infertile, Hirsutism, obesity, acne, acanthosis nigricans etc., be to cause that Women of Childbearing Age is infertile, the modal cause of disease of menoxenia, be because of internal organs The series of complex syndrome that the pathological products such as functional disorder, qi-blood disharmony, the turbid damp expectorant stasis of blood are jammed uterus and skin is formed.Existing Think that its cause of disease relates to the many aspects such as heredity, endocrine, immunity, metabolism for medical science, with hyperandrogenism and high islets of langerhans Element mass formed by blood stasis is principal character, the two definite effect in PCOS falls ill, and it be not immediately clear.Consult traditional Chinese medical science ancient literature, send out Existing Chinese medical book there is no the relevant name of disease of " polycystic ovarian syndrome ", do not only have dysgenesia according to its clinical manifestation characteristic, And having Developmental and Metabolic Disorder i.e.: obesity, amenorrhea, hirsutism, infertile etc., according to the relevant discussion of ancient Chinese medicine doctor, primary disease belongs to the traditional Chinese medical science The category of " amenorrhea " " infertile " " abdominal mass ", sporadically appears in regulating menstruation, asks in the chapter such as heir, seed, and associated name of disease the most just compares Variation, such as: fertile people's amenorrhea, fertile people are infertile, amenorrhea, unsmooth menorrhea, moon water obstructed, metrorrhagia, loss of fecundity, sterilization, breaks, complete Not product etc..The etiology and pathogenesis analyzing PCOS according to tcm theory finds, kidney qi virtual loss is the substantially sick of polycystic ovarian syndrome Machine, the expert such as Penning well, You Zhaoling, Xia Gui city thinks that primary disease is because of congenital kidney water virtual loss, and menses is not enough, multiple condenses institute because of the expectorant stasis of blood Cause, either deficiency of the kidney yin or insufficiency of kidney-YANG, all by occurring because void causes the pathological change of the stasis of blood, cause punching and appoint stagnation of QI-blood, hinder ovum Discharging, or kidney yin water in the last of the ten Heavenly stems is not enough, egg development can not be ripe, and phlegm-damp accumulates resistance, and ovary is the change of many capsules sample and arrives infertile；Yang Yueya Deng it also holds that deficiency of suffering from a deficiency of the kidney, breeding weak, cause follicular development sluggish, the deficiency of vital energy promotes deficiency, causes 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-damp is jammed vessels of the uterus born of the same parents Palace, then can not become pregnant by consolidating semen；Stop up in skin then fat, hirsutism."Fu Qingzhu works on obstetric" is sayed: " woman is kind, and how strongly fragrant bosom is, Liver Channel one Sick ... difficult in fertility." " married woman advises son class " cloud: " feelings are smooth, then punching times is not filled, then tire is pregnant is not subject to." therefore it is believed that Depression 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 road, blood 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 is appointed obstructed, and biochemical function is not Foot, phlegm-damp adipose membrane bets, accumulates stagnant uterus, then see infrequent menstruation, amenorrhea, infertile etc., or the accumulation of phlegm-damp adipose membrane, pent up internal, impregnate four Limb, muscle, then obesity, hirsutism.Be thus PCOS with weakness of the spleen and kidney for this, phlegm-damp for mark, insufficiency of the spleen phlegm-damp is the morbidity of PCOS Crucial.Blood-stasis internal-depression is then the common inducement of this disease, and Thousand Golden Prescriptions points out that " stopping in blood stasis, stagnant blood internal hemorrhage due to trauma " is the former of loss of fecundity One of because of；Errors in Medicine Corrected is sayed: " vigour is the most empty, can not reach in blood vessel, blood vessel depletion of QI, must stop and be the stasis of blood.Stagnation of blood stasis, Punching is appointed deficient logical, and the sea of blood can not overflow as scheduled, delayed menstrual cycle；Stagnation of blood stasis in CHONG and REN meridians, blood must not under, then see amenorrhea；In blood stasis Resistance, escape of blood from meridian and absurd row, it is seen that metrorrhagia；Uterus silt resistance vessels of the uterus then causes infertile.

In sum, PCOS many because suffering from a deficiency of the kidney, stagnation of phlegm-damp, dampness-heat of the liver etc. and cause qi depression to blood stasis, retention of water-damp in the body, metaplasia Turbid damp, blood stasis dispelling of with the passing of time reducing phlegm, the phlegm-damp stasis of blood ties mutually, and the uterus that is jammed, punching are appointed, and punching is appointed and lost money, dirty

Internal organs function and menoxenia due to dysfunction of CHONG meridian and various clinical symptom occurs, its etiology and pathogenesis always with stagnation of liver-QI, insufficiency of the spleen, kidney asthenia as the principal aspect, With blood stasis, phlegm-damp, damp and hot for mark, clinical manifestation is common with syndrome of intermingled deficiency and excess.

2 therapeutic rule researchs

To suffer from a deficiency of the kidney, the pathogenesis such as phlegm-damp, blood stasis, yin deficiency, yang deficiency, deficiency of vital energy, use more the kidney invigorating, reduce phlegm, dampness removing, blood stasis dispelling, QI invigorating, Enrich blood, the therapeutic rules such as warming YANG, kidney deficiency blood stasis type control invigorate blood circulation with nourishing kidney, Chong and Ren Meridians regulating, spleen emptiness and wet sputum type is controlled with drying dampness to eliminate phlegm, reason Controlled atmosphere warp, a lot of scholar of phlegm and blood stasis thinks that PCOS is mainly relevant with kidney,liver,spleen functional disorder, and Qin Zhu etc. passes through literature research Finding, the traditional Chinese medical science treats PCOS in recent years

Type is controlled with kidney-replenishing blood-nourishing, dispersing the stagnated live-QI to relieve the stagnation of QI.Chinese traditional treatment focus on benefit, adjust, logical, but PCOS cause of disease complexity pathogenesis changes various, Clinical manifestation is the most various, and normal many diseases are also seen, therefore should note accompanied symptoms while holding main symptom clinically, needs determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs and differential diagnosis of diseases Opinion is controlled and is combined, and follows the treatment of women distinctive physiological period, over the course for the treatment of, Nervous and Mental Factors to be paid special attention to simultaneously Impact, based on long-time conditioning, haste brings no success.Tcm treatment method about PCOS is studied, and clinical doctor passes through clinical observation The Symptoms of PCOS, uses traditional Chinese medical science organic conception Coryza Treated by Syndrome Differentiation PCOS, sums up various effective Therapeutic Method.Disease Control the prevailing model of always Chinese medicine diagnosis in conjunction with opinion, for PCOS difference pathogenesis, clinical doctor sums up the kidney invigorating especially and reduces phlegm The different Therapeutic Method such as method, invigorating kidney, promoting blood circulation method, liver heat removing and kidney replenishing method, clearing away heat-damp and promoting diuresis method, strengthening spleen and nourishing blood tonneau method.Zhong Xiaoling etc. adopt With the kidney warming nourish blood, blood stasis dispelling tonneau ruling by law treat insufficiency of kidney-YANG, dampness part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels type PCOS patient 30 example, treat 3 cycles, total effective rate It is 86.67%, higher than the 76.67% of the treatment of matched group clomiphene.Liu Ying etc. are respectively adopted the kidney invigorating and adjust liver method and the kidney invigorating Circulation Resolving Phlegm Treatment is suffered from a deficiency of the kidney liver energy stagnation type and is suffered from a deficiency of the kidney phlegm-damp type patient 62 example, and result the kidney invigorating adjusts liver method cure-remarkable-effectiveness rate to be 60.46%, and effective percentage is 88.37%；The kidney invigorating Circulation Resolving Phlegm cure-remarkable-effectiveness rate is 52.64%, and effective percentage is 84.21%.Tan Yong etc. are according to using Chinese medicine adjustment menstruation for many years The experience of circadian rhythm, proposes Chinese medicine and adjusts Zhou Fazhi to treat PCOS, and YIN nourishing postmenstruation is followed in medication, premenstruum YANG invigorating dialectical former Then, YIN nourishing side, YANG invigorating side are made in the side's of sending medication, and according to physiological activity rule in menstrual cycle, simplify medication by stages, sequential fortune PCOS menoxenia main symptom, satisfactory effect is treated with YIN nourishing side and YANG invigorating side.Chinese medicine cycling therapy refers to according to the kidney invigorating-invigorate blood circulation Blood stasis dispelling-the kidney invigorating-promoting blood flow to regulate menstruation, order periodically Selection drug, copy menstrual cycle to treat.Hao Lanzhi uses artificial cycle Therapy, uses the kidney invigorating Gu Chong, helps the method with blood stasis dispelling regulating menstruation, from intending oral medicinal herb side, is divided into Kaohsiung in 4 stage plus-minus treatment PCOS Hormone mass formed by blood stasis patient, result fully recovers 30 examples, effective 10 examples, invalid 6 examples；Recovering ovulation rate is 56.52%, and pregnancy rate reaches 41.67%, Total effective rate 86.96%.Patient 60 example that symbol rosy clouds Artificial menstrual cycle with Chinese herbal medicine therapy for treating polycystic ovarian syndrome is infertile, result is controlled More 41 examples, effective 12 examples, invalid 7 examples, effective percentage 88.33%.In addition, Chinese traditional treatment PCOS also has acupuncture and moxibustion therapy, Chinese medicine to add The therapies such as acupuncture therapeutic alliance and plantar reflecting region massage treatment, all obtain preferable curative effect in clinic.

3 side's medicine applied researcies

The most the more commonly used by side medicine application for the treatment of PCOS, mainly include that compound recipe adds and subtracts treatment, classical prescription treatment, Chinese patent medicine Treatment, famous physician face card experience.Li Qiaofen etc. are by dialectical for PCOS 4 types that are divided into: spleen emptiness and wet sputum type, control with invigorating the spleen and benefiting QI, eliminate the phlegm logical Warp, foshousan plus-minus closes with grey attached expectorant ball of leading in side；Kidney-yang deficiency type, controls with the kidney warming drying dampness to eliminate phlegm, and side's Gui-shen pill is added and subtracted；The stagnation of QI Phlegm retention, controls with depressed liver-energy dispersing and QI regulating, promoting the circulation of QI and reducing phlegm, and side's XIAOYAO POWDER is added and subtracted；Intermingled phlegm and blood stasis type, controls with blood circulation promoting and blood stasis dispelling, drying dampness to eliminate phlegm, Side's Ramulus Cinnamomi Poria pill closes DANGGUI SHAOYAO SAN plus-minus.Sang Xia uses classical prescription Decoction of Gentiana for Purging the Liver-fire plus-minus treatment Liver Channel stagnated fire type PCOS Treat, within 3 months, be 1 course for the treatment of, treat altogether 1 ~ 2 course for the treatment of, observe clinical symptoms before and after treatment, menstrual cycle and serum FSH, LH, E2, T level changes, and result serum Lh, T, LH/FSH lower punching, 25 examples before the most relatively treating, and clinical observation is evident in efficacy.Must justice Chastity etc. gives 60 example patients with polycystic ovary syndrome kidney tonifying Huatan Formulas and controls

Fall (P < 0.01)；3 month to dates recover to pass through 51 examples, and clinical efficacy is good.Xie Jinghong etc. use the many capsules of Chinese medicine preparation Drink (Semen Cuscutae, the Radix Paeoniae Alba, Herba Epimedii, Radix Bupleuri etc.) treatment PCOS suffers from a deficiency of the kidney patients with TCM liver depression 30 example, and 6 months effective percentage for the treatment of are continuously 86.7%, pregnancy rate is 62.5%, and the moon, improved effective percentage was 83.3%, before and after treatment difference be respectively provided with statistical significance (P < 0.05).Liu Yun etc. are found by clinical observation, danzhi xiaoyao pills can improve PCOS companion IR anovulatory sterility patient's ovulation rate and Pregnancy rate, and tcm syndrome, relatively single use of western medicine can be significantly improved there is clear superiority.Chen Hehong etc. sum up the good Experience in Treating of Qin Yue PCOS experience, selects five ability Hydrargyri Oxydum Rubrum soup, Longdan Xiegan Tand Jiawei, red Cape jasmine free and unfettered the patient of different pattern of syndrome according to physiological period respectively Distant dissipate add taste, Gexia Zhuyu Tang adds taste, grey attached Daotan Tang adds taste, three sub-SANHUANG menstruation-regulating soups, removing blood stasis Dang Bao regulating menstruation Tonga taste, pink SIWU TANG adds side's medicines such as taste and treats, and sets up man-made drugs's cycle, and clinical efficacy is notable.

4 modern studies

Along with the development of medical science, a lot of scholars have done for the decoction for the treatment PCOS mechanism of action and have probed into further.Tao Lili etc. lead to Crossing research to find, plus-minus Decoction of Gentiana for Purging the Liver-fire can obviously improve Liver Channel stagnated fire type PCOS patient's hyperandrogenism symptom and endocrine Situation, it is possible to be effectively improved the clinical manifestation of PCOS, the islets of langerhans of Liver Channel stagnated fire type PCOS patient can be corrected the most to a certain extent Element opposing situation, for may play the thecacells pigment of pivotal role in Liver Channel stagnated fire type PCOS develops P450C17 enzymatic activity, plus-minus Decoction of Gentiana for Purging the Liver-fire also has dual regulation effect, and it can be changed by the activity reducing P450C17 enzyme Kind hyperandrogenism, thus play the effect for the treatment of PCOS.Yu Anqi is it has also been found that soothing the liver pathogenic fire purging Chinese medicine can obviously improve Liver Channel Stagnated fire symptom, reduces free testosterone, androstenedione, thus treats hyperandrogenism, can improve body peripheral tissues to islets of langerhans Element sensitivity, improves insulin resistance condition, reduces the serum leptin level raised, and by improving hypothalamo pituitary The function of hypothalamic pituitary ovarium axis, reduces patient LH/FSH, LH, thus improves ovary ovulatory dysfunction, adjusts menstrual cycle, makes part not Pregnant patient becomes pregnant.The research such as Xu Lianwei etc., Wen Jiong shows that invigorating kidney, promoting blood circulation, blood stasis dispelling prescription treatment PCOS can pass through increasing serum SHBG With reduce serum FAI, reduce androgen levels, improve lipid metabolism, improve insulin level, and achieve preferable curative effect. Zhou Lulu research finds that damp abundance due to splenic asthenia type polycystic ovarian syndrome can effectively be treated by invigorating the spleen to clear away damp pathogen medicine, it is possible to improve in serum Hormonal readiness, make the clinical symptoms of patient and sign well be improved.Zhai Jun etc. find Jianpi Bushen associating diformazan Biguanide can obviously reduce metabolic abnormalities of obese women with obese polycystic ovary syndrome LH, T level, improves the sensitivity of insulin, reduces blood fat water Flat, reduce metformin side effect, improve patient compliance, the especially improvement to blood fat and be substantially better than metformin alone Group.Lin Min research is thought and is used the Chinese medicine of dispelling phlegm and eliminating dampness, can reduce phlegm-dampness constitution fat generation in the patient, change lipid generation Thank, reduce blood viscosity, improve apolipoprotein content in blood, thus reach dispelling phlegm and eliminating dampness, lively atmosphere blood, the purpose of Disperse hepatic depression, Phlegm-damp, blood stasis gone, and QI and blood passages through which vital energy circulates is unobstructed, rushes wantonly two arteries and veins and adjusts and reach, then the light body of body is good for, and menses can be able at present.White horse with a black mane Generation is deposited research and is also indicated that TCM Recipe medicine can reduce T, FT, A, thus can be used for treating hyperandrogenism, adjusts LH/FSH ratio Example, nurses one's health Liver and kidney, adjusts menstrual cycle, makes equilibrium between yin and yang make part infertile patient become pregnant.

5 brief summaries

In sum, for a long time PCOS the cause of disease and treatment all in the exploratory development stage, be appreciated that, in middle treatment Applying of all sides of Chinese medicine under then instructing can substantially regulate all cards of PCOS in clinic, but due to for TCM Therapy Related Mechanism and effect link research be scarcely out of swaddling-clothes, in terms of mechanism elaboration shortage Unified Explanation.Along with medical science Development, explores Chinese medicine PCOS preferred plan and verifies that its Related Mechanism will be becoming of future studies Chinese traditional treatment PCOS To.

Medicine of the present invention is the most meticulously to develop through inventor, is mainly used in treating polycystic ovarian syndrome.After deliberation Showing, medicine of the present invention has preferable therapeutic effect to polycystic ovarian syndrome.

In medicine of the present invention, the Ji Yuan of crude drug is as follows:

Rosa bella Rehd et wils is Rosaceae gul Mei QiangwieRosa bella Rehd. et WilsFruit.

Yellow calamite is Berberidaceae berberis Huang calamiteBerberis amurensis Rupr.Root and stem, branch.

Summary of the invention

It is an object of the invention to provide the medicine of a kind of Rosa bella Rehd et wils and yellow calamite.

It is a further object of the present invention to provide the preparation method of this medicine.

Present invention also offers the quality determining method of this medicine.

Present invention also offers the pharmaceutical applications of this medicine.

It is an object of the invention to be realized by the following manner:

A kind of medicine is made up of the raw material of following weight portion: Rosa bella Rehd et wils 1～2 weight portion, yellow calamite 1～2 weight portion.

This medicine is preferably made up of the raw material of following weight portion: Rosa bella Rehd et wils 1 weight portion, yellow calamite 2 weight portion.

This medicine is preferably made up of the raw material of following weight portion: Rosa bella Rehd et wils 2 weight portion, yellow calamite 1 weight portion.

This medicine is preferably made up of the raw material of following weight portion: Rosa bella Rehd et wils 1 weight portion, yellow calamite 1 weight portion.

Described medicine can be prepared as tablet, pill, powder, hard capsule, soft capsule, granule, oral liquid.

Described medicine is adopted and is prepared with the following method: takes Rosa bella Rehd et wils, yellow calamite, mixing, adds the water logging of 3～15 times amount Steeping 0.5～2 hour, decoct 0.5～2 hour, decoct 2～4 times, each 0.5～2 hour, extracting solution merged, and filtered, and filtrate is dense Contracting, dry, pulverize into fine powder, adds adjuvant, mixing, loads hard capsule, to obtain final product.

Described medicine preferably employs following method to be prepared: takes dry Rosa bella Rehd et wils, yellow calamite, adds 11 times amount for the first time Water soaking 1 hour, decocts 1 hour, and second time adds 4 times amount soak by water 1 hour, merges decocting liquid, filters, and filtrate concentrates, and is dried, It is ground into fine powder, sieves, mixing, load hard capsule, to obtain final product.

Detection with the following method adopted by described medicine: use high performance liquid chromatography to carry out the assay of euscaphic acid Jacaric acid:

(1) chromatographic condition: use HypersilDs chromatographic column；Flowing phase: ratio is the acetonitrile-water of 20～40:60～80；Detection Wavelength: 190～210nm；Column temperature: 15～25 DEG C；Flow velocity: 0.5～1.5mL min^-1；Sample size: 5～20 μ L；

(2) prepared by reference substance solution: it is appropriate that precision weighs the euscaphic acid Jacaric acid reference substance being dried to constant weight, adds methanol dissolving and makes comparison Product solution；

(3) preparation of need testing solution: precision weighs medicine of the present invention, adds methanol, is heated to reflux, extracting solution reflux solvent is the denseest Being reduced to do, residue is dissolved in water, and extracts with the shaking of water saturated n-butyl alcohol, merges n-butanol extracting liquid, washs with ammonia solution, just Butyl alcohol extraction liquid recycling design is to dry, and residue adds methanol and dissolves, and shakes up, and filters, takes filtrate, obtain need testing solution；

(4) measure: precision measures above-mentioned need testing solution, reference substance solution each 5～20 μ L respectively, inject high performance liquid chromatography Instrument, detects.

Described medicine preferably employs the detection of following method: use high performance liquid chromatography to carry out measuring containing of euscaphic acid Jacaric acid Fixed:

(1) chromatographic condition: use HypersilDs chromatographic column；Flowing phase: ratio is the acetonitrile-water of 30:70；Detection wavelength: 200nm；Column temperature: 20 DEG C；Flow velocity: 1.0mL min^-1；Sample size: 10 μ L；

(2) prepared by reference substance solution: precision weighs 80 DEG C and is dried to the euscaphic acid Jacaric acid reference substance of constant weight appropriate, adds methanol dissolving and makes Every 1mL reference substance solution containing 0.2mg；

(3) preparation of need testing solution: precision weighs medicine 10g of the present invention, adds methanol 40mL, is heated to reflux 4h, and extracting solution returns Stream solvent is also concentrated to dryness, and the residue 10mL that adds water dissolves, and extracts 5 times with the shaking of water saturated n-butyl alcohol, each 20mL, and merging is just Butyl alcohol extraction liquid, washs 3 times with ammonia solution, each 15mL, and n-butanol extracting liquid recycling design is to dry, and residue adds methanol and dissolves also It is transferred in 10mL volumetric flask, adds methanol to scale, shake up, filter, take filtrate, obtain need testing solution；

(4) measure: precision measures above-mentioned need testing solution, each 10 μ L of reference substance solution respectively, inject high performance liquid chromatograph, enter Row detection.

Described medicine can be used for preparation treatment polycystic ovarian syndrome, the medicine of ovarian cyst or health product.

Experiment one: the medicine of the present invention impact on Model of Polycystic Ovarian Syndrome rat

This experimentation uses progestogen and HCG associating molding method to prepare rats with polycystic ovary syndrome model, before comparing medication Rear hormone serum level changes, to providing experimental data and effect side's medicine for traditional Chinese medical herbal treatment PCOS.

1 experiment material

1.1 laboratory animal

24d age teenage SD female rats, body weight 30 ~ 40g, Heilongjiang University of Chinese Medicine's Experimental Animal Center provide.

1.2 medicines and reagent

Medicine of the present invention: prepare according to the embodiment 1 in description of the invention detailed description of the invention；

Drugs compared first: prepare according to the embodiment 2 in description of the invention detailed description of the invention；

Drugs compared second: prepare according to the embodiment 3 in description of the invention detailed description of the invention；

Metformin: dissolve with distilled water, after converting by people's Mus weight ratio, with 0.018g/d dosed administration.

Test kit: Beijing North great achievement Development Co., Ltd, lot number: RT110371.

2 experimental techniques

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, metformin comparison Group, model control group and negative control group, totally 6 groups, often 10 rats of group.

2.2 experimental technique

0.5mg LNG day 1 subcutaneous injection, when 27d age, add with 2 subcutaneous injections of HCG 1.5IU day, altogether Injection 21d.

After modeling success, (1) medicine of the present invention group: 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) metformin group: give diformazan Biguanide 0.018g/d.Every day 1 gavage, successive administration 15d.

3 experimental results

In each treated animal serum, FSH, LH, T Concentration Testing result, is shown in Table 1-l.Negative control group and the serum of model control group All there were significant differences for the content of FSH, LH and T (P < 0.05), prompting modeling success.

After treatment, in medicine group of the present invention and negative control group serum FSH, the content of LH and T there was no significant difference (P > 0.05), Drug therapy of the present invention is pointed out can to affect the level of FSH, LH and T of PCOS patient so that it is close to normal, and to contrast The effect of medicine first group and drugs compared second group is the best.

In table 1-1 each treated animal serum FSH, LH, T concentration (± S)

Note: compare with model control group, #P < 0.05, ##P < 0.01；Compare with negative control group, ☆ P > 0.05.

4 discuss

Polycystic ovarian syndrome clinical manifestation is the endocrinic syndrome of polymorphism, with Hyperandrogenism and chronic anovulation for facing Bed principal character, is to cause one of modal reason of women at fertile age menoxenia.Its Pathophysiology feature generally acknowledged is: male Hormone generates too much, and high LH is with normal or low-level FSH, hyperinsulinemia-insulin resistant.Polycystic ovarian syndrome LH and T of rat model substantially relatively negative control group raises, and FSH is slightly lower, is because the hypophysis of patients with polycystic ovary syndrome GnRH sensitivity is increased, secretion excess LH and ovary are formed as androgen the cytochrome (cytochromep-of enzyme Functional disorder 450c17), causes stroma of ovary, thecacells to produce excessive androgens.Excessive androgen suppression ovum in ovary Soak ripe, cause developmental follicular atresia, it is impossible to form dominant follicle, so that the normal secretions interrupt of estrogen, but A lot of little follicles still secrete estrogen.The estradiol effect of the certain level of the estrone of continuous release and the secretion of ovary little follicle In hypothalamus and hypophysis, the secretion to LH is positive feedback, makes LH secretion amplitude and frequency increase, and LH is continual high levels, and FSH Level of relative reduces.

5 conclusions

Medicine of the present invention may interfere with the hormonal readiness of patients with polycystic ovary syndrome, thus reaches to cure the purpose of this disease.Especially It is that the action effect of medicine of the present invention is substantially better than drugs compared first and drugs compared second, and two kinds of medicines in medicine of the present invention are described Compatibility between taste is superior, indispensable, and the combination between two kinds of flavour of a drug creates obvious synergistic function, creates one The technique effect adding one more than two.

Experiment two: the effect observation of Drug therapy 40 example polycystic ovarian syndrome of the present invention

The main mode using oral promoting ovulation drug of the treatment of doctor trained in Western medicine polycystic ovarian syndrome (PCOS) in the past, but along with medication The prolongation of time, there is difficult gestation, the phenomenon of easily miscarriage in patient.In recent years, operative treatment, peritoneoscope coagulation have been carried out clinically The modes such as punching art, Effect value must be affirmed, but the wound causing women is the biggest.Research worker application medicine pair of the present invention PCOS patient treats, and achieves good effect.Now report is as follows.

1. data and method

1.1 clinical data

In patients with polycystic ovary syndrome 75 example that my institute is medical during in March, 2015 in February, 2016, all meet " department of obstetrics and gynecology Learn " in about the diagnostic criteria of polycystic ovarian syndrome.Primary symptom: irregular menstruation, occurs that hypomenorrhea or amenorrhea are infertile；Laboratory Check: interstitialcellstimulating hormone (ICSH) (LH)/FSH (FSH) ＞ 3 and (or) testosterone (T) ＞ 2.2nmol/L and (or) androstene Diketone (A) ＞ 9.0nmol/L.Ultrasound diagnosis: side or bilateral ovaries increase, polycystic change.

Rejecting standard: the androgen that 1. other endocrinopathyes cause raises；2. the infertility that other factors cause；③ Psychological problem or the patient of cognitive dysfunction；Within the nearlyest 3 months, took the endocrine medicine of impact or contraceptive person；5. merge The organic diseases such as severe cardiac, kidney, liver.

Age 23～36 years old, the course of disease 1～8 years.Wherein menoxenia 61 example, infertile person 58 example, overweight people 31 example.

Different according to Therapeutic Method, it is divided into observation group and matched group, matched group 35 example, observation group 40 example.2 groups of patient's years Age, the course of disease compare no significant difference (P ＞ 0.05), have comparability.

1.2 Therapeutic Method

Matched group employing regular western medicine treatment spironolactone sheet 40mg, 2 times/d, successive administration 20d.Diformin tablet 0.5g, 3 Secondary/d, to drug withdrawal during normal ovulation.Clomiphene capsule 50mg/d, is used in conjunction 5d.Vitamin C 200mg, 3 times/d, is used in conjunction 20d.

Observation group adds with medicine of the present invention (with reference in description of the invention detailed description of the invention on the basis of matched group Prepared by embodiment 4), each 2, every day 2 times, a point morning and evening takes for 2 times.From menstrual cycle the 7th day, take 3d, drug withdrawal continuously 1d.The course for the treatment of 3 menstrual cycle.

1.3 observation index

Treatment 2 groups of patient clinical symptom variation of fore-and-aft observing, lab testing follicule-stimulating hormone (FSH) (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；

Minimum blood flow rate in PI=(peak systolic velocity-cardiac cycle) time average of/peak veloity,PV.

1.4 efficacy assessment standard

With reference to the standard of polycystic ovarian syndrome in Ministry of Public Health " new Chinese medicine guideline of clinical investigations ":

Recovery from illness: continuous 3 months menstruation recovery normal cycles after drug withdrawal, menstrual period, blood volume are all normal, recover normal ovulation, BBT two-phase Or gestation, tcm syndrome therapeutic index >=90%；

Effective: after treatment, menstruation is close to normal cycle (within 40d), and blood volume is normal, menstrual period 8～10d, 90% ＞ Syndrome in TCM Wait therapeutic index >=66.67%；

Effective: menstrual onset 1 time in treating 3 months, improve in various degree before relatively treating in blood volume, menstrual period, 66.67% ＞ Syndrome in TCM Wait therapeutic index >=33.33%；

Invalid: treatment 3 months continuously, menstrual cycle has no improvement, tcm syndrome therapeutic index ＜ 33.33%.

1.5 statistical method

Use SPSS 15.0 statistical software that data are carried out statistical analysis, enumeration data and measurement data and be respectively adopted χ²Inspection Test, t checks.For difference, there is statistical significance with P ＜ 0.05.

2 results

2.1 2 groups of patient's comparitive study

Observation group's treatment total effective rate is 92.5%, and matched 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.

Therapeutic effect contrast (example) of 2 groups of patients with polycystic ovary syndrome of table 2-1

After 2.2 2 groups of patient treatments, induced ovulation, recovery ovulation, Pregnancy compare

Observation group's follicle maturity rate, recovery ovulation, pregnancy rate are all significantly better than matched group (χ²=9.099,6.857,12.538, P ＜ 0.01), it is shown in Table 2-2.

After 2 groups of patients with polycystic ovary syndrome treatments of table 2-2, induced ovulation, Pregnancy compare ［ example (%) ］

Hormonal readiness change before and after 2.3 treatments

Compared with before treatment, LH, T and LH/FSH all decrease before relatively treating.After treatment, each hormonal readiness phase ratio between group Different statistically significant (t=5.324,6.254,3.413,13.580, P ＜ 0.05), are 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

There is no saying of " polycystic ovarian syndrome " in traditional medicine, it is subordinate to categories such as " amenorrhea " " delayed menstrual cycle " " infertile ".In Doctor thinks, " going out all kidneys through water ", in place of i.e. kidney is store essential substances, is the essential condition risen of feminine menstrual.Deficiency of kidney-QI, the stagnant blood of deficiency and coldness Being primary disease basis, QI and blood expectorant is turbid for folder pathogenesis of holding concurrently.Suffer from a deficiency of the kidney can not rising part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels body fluid, insufficiency of the spleen can not transmitting and distributing the fluids, body fluid water is wet Gathering and form expectorant, phlegm-damp of suffering from a deficiency of the kidney is mingled with, and damages negative and positive mutually.Then induction "-uterus is appointed in kidney-sky decyl-punching " Reproductive Axis dysfunction, i.e. PCOS。

The growth promoter of ovum is by hormone regulating and controllings such as FSH, LH.FSH acts on ovary, promotes developing into of primordial follicle Ripe.When FSH concentration deficiency in follicular fluid, mitosis is obstructed, and follicle cannot continue to grow.Having research to point out, FSH level exists In the selection of dominant follicle most important.LH is the characteristic change that PCOS patient lab checks extremely, is also reproduction merit The basic reason of energy obstacle.Internal too high LH can promote that thecacells, Interstitial cell produce a large amount of androgens, and converts For estrone.Estrone can upset the formation at LH peak in menstrual cycle, affects maturation and the discharge of follicle.This research shows, observation group LH/FSH ratio after treatment significantly reduces, and T hormonal readiness declines, and contributes to the growth of mature follicle and increases intrauterine The growth of film.Prompting, medicine of the present invention can warming and recuperating the 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 show, observation group's treatment total effective rate is 92.5%, and simple western medicine only 71.4%.Additionally, observation group's recovery ovulation situation, Pregnancy rate is significantly better than matched group, say, that PCOS patient is ovulated by medicine of the present invention, gestation is the most useful.

Experiment three: the experimentation of Drug therapy ovarian cyst of the present invention

Ovarian cyst (OvarianCyst, OC) is one of common benign tumor of modern gynecological, accounts for the 75% of ovarian tumor.It Refer to that ovary is internally generated Cystic lesions, Non-cancerous and tumprigenicity two class can be divided into, be equal to the traditional Chinese medical science " abdominal mass " " accumulation " " intestinal Deep " etc. sick category, be mainly in the young women of 20～50 years old, sickness rate accounts for the 15% of the women of child-bearing age.During research worker is used Theory of medicine inquires into basic pathogenesis and the Therapeutic Principle of OC, it is believed that this disease many ignorance in menstrual period or puerperal because of women nurses one's health, because of seven Invade in the heresy of feelings internal injury or six climate exopathogens, visceral dysfunction, raw in causing turbid damp phlegm retention, stagnation of blood stasis vessels of the uterus, accumulation with the passing of time shape Become cyst.Its pathogenesis core is stagnation of liver-QI with deficiency of the spleen, phlegm and blood stasis.Treat suitable invigorating the spleen and relieving depression of liver-QI, dampness removing reduces phlegm, blood circulation promoting and dispersing pathogen accumulation.

Medicine of the present invention has extraordinary therapeutic effect to polycystic ovarian syndrome, and research worker is predicted, medicine of the present invention Ovarian cyst also should be had certain therapeutic effect, the most just carried out trial row experimentation, observe medicine of the present invention On interleukin-6(IL-6 in OC rat model blood), estradiol (E2), progesterone (P) content impact.

1 material

1.1 experimental animal

SPF level healthy adult female wistar rat 75, at two monthly ages, body weight (200 ± 10) g, experimental animal is by Heilungkiang Medical pharmaceutical university Experimental Animal Center provides.

1.2 medicines and preparation

Medicine of the present invention: prepare with reference to the embodiment 1 in description of the invention detailed description of the invention.It is condensed into every milliliter respectively to contain Crude drug 1, two kinds of medicinal liquids of 2g, as low dose group and high dose group.Put 4 DEG C of preservations in refrigerator.

Positive control drug: Ramulus Cinnamomi Poria pill (poplar Wenshui, Shanxi pharmaceutical Co. Ltd, traditional Chinese medicines quasi-word Z14020791), every ball Weight 6g.

1.3 main agents

10% chloral hydrate, 10% mustard oil, paraffin oil, injection normal saline, medical povidone iodine.Operating theater instruments a set of (scalpel, Big staight scissors, big curved scissors, tissue clamps, ophthalmic tweezers, mosquito forceps, stitching needlework, aseptic cotton balls, medical gloves, disposable syringe Deng).

1.4 main equipment

Full-automatic chemiluminescence apparatus, ADVIAXP(Siemens)；(biological limited public affairs are built up in Nanjing to gonadal hormone test kit Department)；Rat, IL-6ELISA, ERC003(Xin Bosheng bio tech ltd)；Freezing microtome, Finesse325(Britain three Bio tech ltd)；Analytical balance, BS110S(Beijing Sai Duolisi balance company limited)；White mouse complete set cage (Soviet Union Tremble with fear mountain metal product plant in state).

2 methods

2.1 test packets

Animal is randomly divided into 5 groups, often group 15.It is respectively normal group, model group, Ramulus Cinnamomi Poria pill group, low dose of medicine of the present invention Amount group, medicine high dose group of the present invention.

2.2 modeling method

With reference to the refined chastity of Wesselmann(king. practical obstetrics and gynecology [M]. Beijing: People's Health Publisher, 2000:707) cause for big Mus " ovarian cyst " model, after using 10% chloral hydrate abdominal cavity (0.35/100g) injecting anesthetic, making rat is dorsal position, fixing On dissecting table, Ventral Midline shaves off Mus hair routine disinfection, makees the otch of 1.5cm length and vertical direction in Ventral Midline, cuts Being pubic symphysis at 0.5cm above mouth lower end, herein, chorista and the liparitosis held, find defeated ovum on rear side of bladder Pipe, finds out left ovary along ampulla of uterine tube, notes by the mustard oil (the mustard oil paraffin oil of 95% dilutes) of 0.1mL10% Enter ovary, with soft wax, injection pinprick is sealed, prevent overflow of drug fluid.Layering suture operation otch, terminal disinfection otch, by white mouse Put back in cage.The acute congestion edema of internal organs can be caused after general injection mustard oil 2h, occur that inflammatory reaction forms cyst.At note Win rats with left ovary after penetrating 2h, after 10% formaldehyde fixes 48h, ethanol serial dehydration, carry out the frozen section system of 15 μm Make, carry out HE dyeing.Form at two groups of ovaries of low power Microscopic observation, it can be seen that after injection mustard oil, the ovary of rat is obvious Congested, edema.With ovarian cyst > 10mm is for modeling successfully.

2.3 medication

Modeling success each group random assortment completes i.e. to start to be administered.Medicine high dose group of the present invention, medicine low dose group of the present invention Gavage medicine decocting liquid of the present invention respectively, be respectively equivalent to containing crude drug 50g kg^-1·d^-1With 25g kg^-1·d^-1；Cassia twig tuckahoe Ball group gavages isometric Ramulus Cinnamomi Poria pill suspension；Normal group and model group fill with isometric normal saline.All press for each group 0.25mL·10g^-1·d^-1Gavage.1 time/d, continuous 6 weeks.

2.4 method of drawing material

After being grouped, blood will be taken by rat tail, put in labelling clearly EP pipe.Gavage uses same method to take after 6 weeks Blood.Measure before and after often group processes IL-6 and the content of gonadal hormone (estradiol, progesterone) in rat blood.

2.5 statistical procedures

Measured data acquisition statistic software SPSS 13.0 is analyzed, and measurement data uses (sx ±) to carry out statistics and describes.Warp After homogeneity test of variance, between each group, carry out the analysis of variance F.Comparing between group and check with t, P < 0.05 represents that difference has statistics Meaning.

3 results

Comparing with Normal group, IL-6 and the content of gonadal hormone (estradiol, progesterone) in model group are significantly raised, are shown in Table 3- 1。

IL-6, estradiol, the content of progesterone in rat blood serum is respectively organized before table 3-1 treatment

After medicine of the present invention and Guizhi Fuling Pills in Treating, it was observed that big in Ramulus Cinnamomi Poria pill group of IL-6, estradiol, progesterone Content in Mus blood all decreases (P < 0.05), and IL-6, estradiol, progesterone medicine high dose group of the present invention, this The content in rat blood in bright medicine low dose group the most substantially reduces (P ＞ 0.05), is shown in Table 3-2.

IL-6, estradiol, the content of progesterone in rat blood serum is respectively organized after table 3-2 treatment

4 conclusions

This experimentation shows, medicine of the present invention can not reduce the level of IL-6, it is impossible to suppression local fibroblasts hypertrophy, fibre Fibrillarin is formed and collagen deposition, can not alleviate ovarian cyst focus inflammatory adhesion and fibrosis, the growth to ovarian cyst There is no inhibitory action, so, drugs on ovarian cyst of the present invention is without therapeutical effect, it is impossible to make cyst atrophy.

Experiment four: the quality determining method research of medicine of the present invention

1 instrument and reagent

1.1 instrument

High performance liquid chromatograph (examine for Agilent110 high performance liquid chromatograph and work station, G1311Aquat pump by G1314 ultraviolet Survey device).

1.2 reagent

Euscaphic acid Jacaric acid reference substance (China pharmaceutical biological product calibrating academy)；Chinese medicine composition of the present invention；Chinese crude drug (Harbin Pharmaceutical Group The people provide with safe chain pharmacy)；Methanol (chromatograph alcohol, biochemistry work auxiliary reagent factory, Shanghai)；Other reagent are analytical pure.

2 methods and result

2.1 prescription

Rosa bella Rehd et wils 500g, yellow calamite 500g.

2.2 preparation

Take dry Rosa bella Rehd et wils 500g, yellow calamite 500g, add 11000mL water soaking 1 hour for the first time, decoct 1 hour, second The secondary 4000mL that adds, decocts 1 hour, merges decocting liquid, filters, and filtrate concentrates, and is dried, to obtain final product.

The assay of 2.3 euscaphic acid Jacaric acids

2.3.1 HPLC chromatogram condition

Use HypersilDs(4.0mm × 125mm, 5 μm) chromatographic column；Flowing phase: ratio is the acetonitrile-water of 30:70；Detection ripple Long: 200nm；Column temperature: 20 DEG C；Flow velocity: 1.0mL min^-1；Sample size: 10 μ L；Under this chromatographic condition, reference substance and sample color Spectral peak is good, noiseless to measuring without Rosa bella Rehd et wils negative control.

2.3.2 the preparation of reference substance solution

Precision weighs 80 DEG C and is dried to the euscaphic acid Jacaric acid reference substance of constant weight appropriate, adds methanol and makes every 1mL solution containing 0.2mg.

2.3.3 need testing solution and the preparation of negative controls

Precision weighs medicine 10g of the present invention, adds methanol 40mL, is heated to reflux 4h, and extracting solution reflux solvent is also concentrated to dryness, residue The 10mL that adds water dissolves, and extracts 5 times with the shaking of water saturated n-butyl alcohol, each 20mL, merges n-butanol extracting liquid, wash with ammonia solution Washing 3 times, each 15mL, n-butanol extracting liquid recycling design is to dry, and residue adds methanol and dissolves and be transferred in 10mL volumetric flask, adds Methanol, to scale, shakes up, and filters, takes filtrate and get final product；The negative controls of Rosa bella Rehd et wils, same method is not separately contained in the preparation of prescription ratio Make negative controls.

2.3.4 the drafting of standard curve

Precision weighs 80 DEG C and is dried to the euscaphic acid Jacaric acid reference substance of constant weight appropriate, makes 10.4 with methanol, and 20.8,41.6,83.2, 166.4μgmL^-1The solution of series concentration, precision measures each 10 μ L of above-mentioned 5 kinds of strength solution respectively, injects high performance liquid chromatograph It is measured.

Carrying out linear regression with peak area ratio and concentration, obtaining regression equation is: A=21.2763C-0.1391, r= 0.9999.Show that euscaphic acid Jacaric acid is at 10.4～166.4 μ gmL^-1In good linear relationship in concentration range.

2.3.5 stability test

Accurate absorption need testing solution 10 μ L, respectively at 0,1,2,4,8h sample introduction, and calculate euscaphic acid Jacaric acid content.RSD in result 8h For 0.45%(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, measure euscaphic acid Jacaric acid content in accordance with the law and calculate.Result records Flos Rosae Multiflorae Acid average content is 0.12mg g^-1, RSD is 1.3%.

2.3.7 Precision Experiment

Accurate euscaphic acid Jacaric acid reference substance solution of drawing, repetition sample introduction 5 times, measure peak area in accordance with the law.Result RSD is 0.23%(n=5). Show that precision is preferable.

2.3.8 response rate experiment

Precision weighs 6 parts of the sample of the same lot number of known euscaphic acid Jacaric acid content, adds appropriate by high, medium and low concentration precision respectively Euscaphic acid Jacaric acid reference substance solution, by under sample determination item operate, measure in accordance with the law, calculate the response rate.Result average recovery rate is 100.3%, RSD are 0.45%(n=5).

2.3.9 sample size measures

Measuring reference substance solution respectively and need testing solution is appropriate, filter with microporous filter membrane, each sample introduction 10 μ L, by above-mentioned chromatostrip Part measures 3 batch samples, parallel assay 5 times.By external standard method with the content of calculated by peak area need testing solution euscaphic acid Jacaric acid.This product contains rose Common vetch acid should be and indicates the 95%～105% of content, contains in terms of euscaphic acid Jacaric acid by every 1g sample, must not be less than 0.12mg.3 batch sample content divide Wei 100.8%(RSD=1.2%), 101.7%(RSD=1.3%), 99.2%(RSD=1.1%).

Detailed description of the invention:

Embodiment 1: medicine of the present invention

Prescription: Rosa bella Rehd et wils 50g, yellow calamite 50g

Preparation method: take dry Rosa bella Rehd et wils 50g, yellow calamite 50g adds 1100mL water soaking 1 hour for the first time, decocts 1 little Time, second time adds 400mL, decocts 1 hour, merges decocting liquid, filters, and filtrate concentrates, and is dried, obtains medicine of the present invention.

Embodiment 2: drugs compared first

Prescription: Rosa bella Rehd et wils 100g

Preparation method: take dry Rosa bella Rehd et wils 100g, adds 1100mL water soaking 1 hour for the first time, decocts 1 hour, for the second time Adding 400mL, decoct 1 hour, merge decocting liquid, filter, filtrate concentrates, and is dried, obtains drugs compared first.

Embodiment 3: drugs compared second

Prescription: yellow calamite 100g

Preparation method: take dry yellow calamite 100g, adds 1100mL water soaking 1 hour for the first time, decocts 1 hour, and second time adds 400mL, decocts 1 hour, merges decocting liquid, filters, and filtrate concentrates, and is dried, obtains drugs compared second.

Embodiment 4: pharmaceutical hard capsule agent of the present invention

Drug prescription: Rosa bella Rehd et wils 500g, yellow calamite 500g

Preparation method: take dry Rosa bella Rehd et wils 500g, yellow calamite 500g, add 11000mL water soaking 1 hour for the first time, decoct 1 Hour, second time adds 4000mL, decocts 1 hour, merges decocting liquid, filters, and filtrate concentrates, and dry, pulverize into fine powder, adds auxiliary Material, mixing, load hard capsule, make 1000..

Use high performance liquid chromatography that euscaphic acid Jacaric acid carries out assay:

(2) prepared by reference substance solution: precision weighs 80 DEG C and is dried to the euscaphic acid Jacaric acid reference substance of constant weight appropriate, adds methanol and makes often The 1mL solution containing 0.2mg；

(4) measure: precision measures above-mentioned need testing solution, each 10 μ L of reference substance solution respectively, inject high performance liquid chromatograph, enter Row detection, testing result be the content of euscaphic acid Jacaric acid be 0.1823mg/g.

Although moreover, it will be appreciated that this specification is been described by according to embodiment, but the most each embodiment only wraps Containing an independent technical scheme, this narrating mode of description is only that for clarity sake those skilled in the art should Description can also be formed those skilled in the art through appropriately combined as an entirety, the technical scheme in each embodiment May be appreciated other embodiments.

Claims

1. the medicine treating polycystic ovarian syndrome, it is characterised in that this medicine is made up of the raw material of following weight portion : Rosa bella Rehd et wils 1～2 weight portion, yellow calamite 1～2 weight portion.

2. medicine as claimed in claim 1, it is characterised in that this medicine is made up of the raw material of following weight portion: Mei Qiangwie Really 1 weight portion, yellow calamite 2 weight portion.

3. medicine as claimed in claim 1, it is characterised in that this medicine is made up of the raw material of following weight portion: Mei Qiangwie Really 2 weight portion, yellow calamite 1 weight portion.

4. such as claim 1 medicine, it is characterised in that this medicine is made up of the raw material of following weight portion: Rosa bella Rehd et wils 1 weight Amount part, yellow calamite 1 weight portion.

5. the medicine as described in any one in Claims 1 to 4, it is characterised in that this medicine is prepared as tablet, pill, dissipates Agent, hard capsule, soft capsule, granule, oral liquid.

6. medicine as claimed in claim 5, it is characterised in that this medicine is adopted and prepared with the following method: take Rosa bella Rehd et wils, Huang Lu Wood, mixing, the water soaking 0.5 of addition 3～15 times amount～2 hours, decoct 0.5～2 hour, decoct 2～4 times, each 0.5～2 Hour, extracting solution merges, and filters, and filtrate concentrates, and dry, pulverize into fine powder, adds adjuvant, mixing, loads hard capsule, to obtain final product.

7. medicine as claimed in claim 6, it is characterised in that this medicine is adopted and prepared with the following method: take dry Mei Qiangwie Really, yellow calamite, add 11 times amount water soaking 1 hour for the first time, decoct 1 hour, second time adds 4 times amount soak by water 1 hour, merging water Decocting liquid, filters, and filtrate concentrates, and dry, pulverize into fine powder, sieves, and mixing loads hard capsule, to obtain final product.

8. a quality determining method for medicine, this medicine is made up of the raw material of following weight portion: Rosa bella Rehd et wils 1～2 weight Amount part, yellow calamite 1～2 weight portion, it is characterised in that detection with the following method adopted by this medicine: use high performance liquid chromatography to enter The assay of row euscaphic acid Jacaric acid:

9. the quality determining method of as claimed in claim 8 medicine, this medicine is made up of the raw material of following weight portion: U.S. rose Common vetch fruit 1～2 weight portions, yellow calamite 1～2 weight portion, it is characterised in that detection with the following method adopted by this medicine: use high-efficient liquid Phase chromatography carries out the assay of euscaphic acid Jacaric acid:

10. the medicine as described in any one in Claims 1 to 4 is in the medicine or health product of preparation treatment ovarian cyst Application.