CN105497262A - Medicine composition for treating liver-yin and kidney-yin deficiency type polycystic ovarian syndrome - Google Patents
Medicine composition for treating liver-yin and kidney-yin deficiency type polycystic ovarian syndrome Download PDFInfo
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Abstract
The invention belongs to the technical field of medicine and relates to a medicine composition for treating liver-yin and kidney-yin deficiency type polycystic ovarian syndrome and a preparation method thereof. The medicine composition is formed by elaborately compounding ten types of crude drugs, namely glossy privet fruits, prepared rehmannia roots, Chinese dodder seeds, acanthopanax roots, all grass of serissa serissoides (DC.) druce, stellaria yunnanensis roots, herba leonuri, roots of faber galeola, roots of boerhaavia diffusa L.[B. repens L.] and Chinese holly leaves, and other medicinal materials, the effects of tonifying kidney, nourishing the liver, invigorating the spleen, supplementing qi, invigorating blood circulation to dispersing blood stasis and nourishing blood for regulating menstruation are achieved, no cold and heat deviation exists, tonifying is conducted without causing stagnation, and a great targeting effect is achieved for liver-yin and kidney-yin deficiency type polycystic ovarian syndrome.
Description
Technical field
The invention belongs to medical art, relate to and a kind ofly treat pharmaceutical composition of liver-kidney yin deficiency polycystic ovarian syndrome and preparation method thereof.
Background technology
Polycystic ovarian syndrome (Polycysticovariansyndrome, PCOS) is a kind of clinical common endocrine regulation syndrome, and clinical multilist is now deposited for reproductive dysfunction and abnormal carbohydrate metabolism.Clinical have irregular menstruation (most of patients shows as hypomenorrhea or amenorrhea, and minority can show as polymenorrhea or menstruation rule), hirsutism more, fat, the performances such as acanthosis nigricans.PCOS often causes Women of Childbearing Age Ovulation barrier sterile, and in relevant report at home, in infertile crowd, PCOS prevalence accounts for 30%-40%, not ovulatoryly infertile accounts for about 75%.
At present large quantifier elimination is done to PCOS, its basic feature mostly is long-term anovulation, insulin resistant and hyperinsulinemia, the metabolism syndromes such as hyperandrogenism, diabetes, hypertension are the common complications of PCOS, and PCOS is also the focus studied in gynecological endocrine field in recent years.Western medical treatment PCOS still the androgen antagonist such as Bian Diane-35, metformin, oral contraceptive, improve insulin resistant and regulate the treatments such as menstrual cycle, have that untoward reaction is many, the easy shortcoming such as repeatedly, curative effect is still not fully up to expectations.
PCOS discusses without disease that calls for specialized treatment in Chinese medicine, according to its clinical manifestation, sporadically appears in " menoxenia ", " infertile ", " metrorrhagia ", “ mass in the abdomen " etc. in chapter, differentiation of tcm is with a long history, and method is various, many tools characteristic in treatment.The research of motherland's medical science to this disease deepens continuously, treatment has obtained gratifying curative effect, there are some researches show that Chinese medicine is strangled point (comprising ovary, hypophysis, the ovary internal regulation factor etc.) by multiple effect and played therapeutical effect, there is certain advantage, seem be even more important so seek the therapeutic regimen of Chinese medicine to this disease.
Summary of the invention
In order to solve the problem, the present invention aims to provide one, and to have prescription rigorous, compatibility science, evident in efficacy, curative effect of medication can be played to greatest extent, and easy to prepare, patient compliance is good, the pharmaceutical composition and preparation method thereof of the treatment polycystic ovarian syndrome had no side effect especially liver-kidney yin deficiency polycystic ovarian syndrome.
An object of the present invention is to provide a kind of pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome.
Another object of the present invention is to provide a kind of preparation method for the treatment of the pharmaceutical composition of liver-kidney yin deficiency polycystic ovarian syndrome.
Inventor combines theory and the clinical experience of oneself of the sage of the past at all times, doctor trained in Western medicine differential diagnosis of diseases, distinguish because of microcosmic detection to treat with traditional Chinese medical science macroscopic syndrome and combine, a kind of pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome provided, its by Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., old come the ten taste crude drug elaborates such as blue or green, Folium Mahoniae.
The consumption of medicinal raw material of the present invention is groped to sum up to draw through inventor in a large number, preferably, treat a pharmaceutical composition for liver-kidney yin deficiency polycystic ovarian syndrome, it is made up of the crude drug of following weight: Fructus Ligustri Lucidi 13-26 part, Radix Rehmanniae Preparata 10-20 part, Semen Cuscutae 6-26 part, Radix Et Caulis Acanthopanacis Senticosi 5-15 part, Serissa foetida 10-20 part, Radix Stellariae Yunnanensis 10-30 part, Herba Leonuri 5-15 part, Galeola faberi Rolfe. 5-15 part, old next blue or green 10-25 part, Folium Mahoniae 10-25 part.
Further preferably, treat a pharmaceutical composition for liver-kidney yin deficiency polycystic ovarian syndrome, it is made up of the crude drug of following weight: Fructus Ligustri Lucidi 16-21 part, Radix Rehmanniae Preparata 12-17 part, Semen Cuscutae 13-18 part, Radix Et Caulis Acanthopanacis Senticosi 8-13 part, Serissa foetida 13-18 part, Radix Stellariae Yunnanensis 15-20 part, Herba Leonuri 7-12 part, Galeola faberi Rolfe. 5-9 part, old next blue or green 13-18 part, Folium Mahoniae 16-21 part.
Further preferably, treat a pharmaceutical composition for liver-kidney yin deficiency polycystic ovarian syndrome, it is made up of the crude drug of following weight: Fructus Ligustri Lucidi 20 parts, Radix Rehmanniae Preparata 15 parts, Semen Cuscutae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, Serissa foetida 16 parts, Radix Stellariae Yunnanensis 15 parts, Herba Leonuri 10 parts, Galeola faberi Rolfe. 7 parts, old next blue or green 18 parts, Folium Mahoniae 20 parts.
Fang Zhong: Radix Rehmanniae Preparata is sweet, tepor, nourishing YIN and supplementing blood, beneficial essence fills out marrow; Fructus Ligustri Lucidi sweet, bitter, cold, replenishing YIN to strengthen the kidney, QI invigorating soothing liver-QI; Semen Cuscutae is sweet, the kind kidney-replenishing of temperature, mends and not high, temperature and not dry, cold can temperature, heat can be cool, in fact can be in order to, and the kidney invigorating nourishing the liver, warming the spleen helps stomach, the three medicines 5 cloudy blood of nourishing the liver and kidney, and YANG invigorating tonifying YIN, in treating YIN within YANG, is monarch drug.Pungent, the micro-hardship of Radix Et Caulis Acanthopanacis Senticosi, temperature, kind replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, promoting blood circulation to remove obstruction in the collateral; Serissa foetida is light, micro-pungent, cool in nature, invigorating spleen to remove dampness, and soothing liver-QI is invigorated blood circulation; Radix Stellariae Yunnanensis is sweet, and property is put down, and strengthening spleen and nourishing blood, the liver and the kidney tonifying, three medicine 5 Yishen Jianpis, Huoxue Shugan, nourishing blood and invigorating qi, QI and blood interpromoting relation in five elements, essence and blood are changed mutually.Herba Leonuri is bitter, pungent, and be slightly cold, promoting the circulation of blood is nourished blood, promoting the circulation of blood and do not hinder fresh blood, nourishes blood and not stagnant blood stasis; Old come blue or green hardship, pungent, temperature, promoting blood circulation to remove blood stasis, bone and muscle strengthening, regulating menstruation; Galeola faberi Rolfe., heat-clearing and toxic substances removing, regulating menstruation; Folium Mahoniae is bitter, cool, and take a tonic or nourishing food to build up one's health cloudy gas, clearing away heat and nourishing YIN, suppressing the hyperactive liver kidney tonifying is clear; Four medicines are adjuvant drug.All medicines interact, and combined into it, have the merit of the kidney invigorating nourishing the liver, invigorating the spleen and benefiting QI, promoting blood circulation to remove blood stasis, nourishing blood for regulating menstruation, partially without cold and heat, and tonify without causing stagnation is evident in efficacy.
The pharmaceutical research present situation of the present invention's each medicinal raw material used is as follows:
Fructus Ligustri Lucidi: [nature and flavor] sweet, bitter, cold.[return through] returns liver, kidney channel.[function cures mainly] nourishing the liver and kidney, improving eyesight black hair.For vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision." book on Chinese herbal medicine is new again ": " replenishing YIN to strengthen the kidney, QI invigorating soothing liver-QI.Control lumbago and skelalgia, stimulate the menstrual flow and blood.”
Radix Rehmanniae Preparata: [nature and flavor] are sweet, tepor.[return through] returns liver, kidney channel.[function cures mainly] nourishing YIN and supplementing blood, beneficial essence fills out marrow.For the hepatic and renal YIN deficiency, soreness of the waist and knees, osteopyrexia and fever, night sweat is passed out semen, and interior-heat is quenched one's thirst, blood deficiency and yellow complexion, severe palpitation, menoxenia, and metrostaxis is dizzy, tinnitus, early whitening of beard and hair.[usage and dosage] 9 ~ 15g.
Semen Cuscutae: [nature and flavor] are sweet, temperature.[return through] returns liver,kidney,spleen warp.[function cures mainly] nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.For impotence and seminal emission, dripping urination, enuresis frequent micturition, soreness of the waist and knees, blurred vision tinnitus, vaginal bleeding due to deficiency of the kidney during pregnancy, frequent fetal movement, spleen is suffered from a deficiency of the kidney and is rushed down; Externally treating leucoderma.[usage and dosage] 6 ~ 12g; Suitable amount used externally.
Radix Et Caulis Acanthopanacis Senticosi: [nature and flavor] pungent, micro-hardship, temperature.[return through] returns spleen, kidney, heart channel.[function cures mainly] replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization.For deficiency of spleen-YANG and kidneyYANG, body void is weak, inappetence, soreness of waist and knee joint, insomnia and dreamful sleep.[usage and dosage] 9 ~ 27g.
Serissa foetida: [nature and flavor] are lightly seasoned, micro-pungent, cool in nature.[function cures mainly] invigorating spleen to remove dampness, soothing liver-QI is invigorated blood circulation.For infantile malnutrition, acute, chronic hepatitis, amenorrhea, leucorrhea, lumbago due to pathogenic wind-dampness.
Radix Stellariae Yunnanensis: be the root of pinkwort Yunnan Herba stellariae mediae.[nature and flavor] are sweet; Property is put down.[return through] liver; Spleen; Kidney channel.[function cures mainly] strengthening spleen and nourishing blood; The liver and the kidney tonifying; Detumescence.Main anemia; Spirit is deficient; Dizzy nervous; Tinnitus dim eyesight; Hectic fever; Seminal emission; Menoxenia; Leukorrhagia; Fracture; Mastitis.[usage and dosage] takes orally: decoct soup, 15-30g; Or fricassee clothes.External: appropriate, fresh goods is smash deposited.
Herba Leonuri: [nature and flavor] are bitter, pungent, are slightly cold.[return through] returns liver, pericardium channel.[function cures mainly] promoting blood flow to regulate menstruation, inducing diuresis to remove edema.For menoxenia, dysmenorrhea, amenorrhea, lochiorrhea, edema oliguria; Acute nephritis edema.[usage and dosage] 9 ~ 30g; Fresh goods 12 ~ 40g.
Old next blue or green: [nature and flavor] are bitter, pungent, temperature.[function cures mainly] promoting blood circulation to remove blood stasis, bone and muscle strengthening, regulating menstruation, disappear infantile malnutrition; For bones and muscles pain, lumbago and skelalgia, menoxenia, leucorrhea, anorexia, spleen is suffered from a deficiency of the kidney edema, and void is coughed, infantile malnutrition.
Galeola faberi Rolfe.: [nature and flavor] acid; Micro-hardship; Cold.[return through] heart; Liver; Spleen; Large intestine channel.[function cures mainly] heat-clearing and toxic substances removing; Regulating menstruation, hemostasis; Convergence is solid de-.Main jaundice due to damp-heat; Dysentery pus and blood; Sore and toxic; Venom; Menoxenia; Metrorrhagia; Uterine prolapse; Proctoptosis.[usage and dosage] takes orally: decoct soup, 6-9g.External: appropriate, smashes deposited." Xinhua's book on Chinese herbal medicine outline ": the effect having eliminating inflammation and expelling toxin, regulating menstruation, hemostasis.For uterine prolapse, proctoptosis, neurasthenia, paratyphoid fever, hepatitis, sore, venom.
Folium Mahoniae: [nature and flavor] are bitter; Cool.[return through] liver; Kidney channel.[function cures mainly] clearind deficient heat; Liver and kidney tonifying; Wind-damp dispelling.Main hectic fever due to deficiency of YIN; Cough spitting of blood; Have a dizzy spell; Soreness of the waist and knees; Rheumatic arthralgia; Vitiligo.[usage and dosage] takes orally: decoct soup, 9-15g.External: appropriate, smashes juice or endures cream coating.
The pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome provided by the present invention, directly by Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., old next blue or green, Folium Mahoniae pulverizing, pulvis can be prepared into oral; Also each component directly can be mixed and made into coarse powder, the effective ingredient extracted in coarse powder makes extractum, extractum is utilized to be prepared into peroral dosage form, as tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution etc., other dosage form being suitable for treating liver-kidney yin deficiency polycystic ovarian syndrome can also be prepared into.
Inventor considers the factors such as recipe quantity, pharmaceutical properties, medication object, easy to use, cost of manufacture, preferably makes capsule, tablet, granule; Most preferably make capsule, be directly mixed and made into coarse powder by each component, the effective ingredient extracted in coarse powder makes extractum, and this effective ingredient is independent or mix with medicine acceptable carrier, is prepared from according to galenic pharmacy routine techniques.
Present invention also offers the preparation method of this pharmaceutical composition, it comprises the steps: described Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., always next blue or green, Folium Mahoniae to mix in prescription ratio, add the water relative to mixture quality 4 ~ 10 times, decoct 2 ~ 3 hours, filter acquisition first extracting solution; The medicinal residues that filtration obtains add the water relative to described medicinal residues quality 2 ~ 4 times again, decoct 1 ~ 2 hour, filter acquisition second extracting solution; First extracting solution and the second extracting solution are merged, adding ethanol makes alcohol content be 30%v/v, leave standstill after 24 hours, obtain supernatant, be the ultrafiltration post ultrafiltration of 7500-9000 again through the molecular weight that dams, ultrafiltrate subtracts and is concentrated into relative density 1.05-1.10 (60 DEG C record), inlet temperature 140 ~ 150 DEG C, carry out spraying dry under leaving air temp 75 ~ 80 DEG C of conditions, obtain active constituents of medicine; This composition is independent or mix with medicine acceptable carrier, makes pharmaceutical composition of the present invention according to galenic pharmacy routine techniques.
The component of the present composition all adopts natural raw material of Chinese medicine, and its preparation is easy, medicine source is wide, cost is low.It follows the prescriptions principle of the traditional Chinese medical science, and verify through clinical observation test example 9, it is evident in efficacy, reliable effect, mild in medicine property and, there is not toxic and side effects; Chinese drug-treated group obvious effective rate 58.3%, total effective rate 97.2%; Western medicine group obvious effective rate 33.3%, total effective rate 77.8%, Chinese drug-treated group compares with Western medicine group obvious effective rate, total effective rate, and difference has statistical significance (P < 0.05); After treatment, Chinese drug-treated group TCM symptom score is all than obviously less before treatment, statistical significance (P < 0.01) is had with comparing difference before treatment, Chinese drug-treated group is improving dysphoria with feverish sensation in the chest palms and soles, dizziness and tinnitus, the aspects such as soreness of the waist and knees are better than Western medicine group, in 3rd cycle after drug withdrawal, Western medicine group symptom integral returns to again the front level for the treatment of and Chinese drug-treated group still keeps the level (P < 0.01) after treating.Therefore, the present invention also asks the purposes of protection aforementioned pharmaceutical compositions in the medicine of preparation treatment polycystic ovarian syndrome especially liver-kidney yin deficiency polycystic ovarian syndrome.
The present invention relatively and prior art, there is following clear superiority: first, pharmaceutical composition prescription of the present invention mainly develops according to the pathogenic characteristic of polycystic ovarian syndrome particularly liver-kidney yin deficiency polycystic ovarian syndrome, the merit of full side's the kidney invigorating nourishing the liver, invigorating the spleen and benefiting QI, promoting blood circulation to remove blood stasis, nourishing blood for regulating menstruation, partially without cold and heat, tonify without causing stagnation, has extremely strong specific aim curative effect to liver-kidney yin deficiency polycystic ovarian syndrome.
Chinese medicine preparation of the present invention adopts advanced extraction equipment and technique, abundant effective component extracting, can be made into and facilitates Chinese medicine preparation that is oral or that carry, as tablet, capsule or granule.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 capsule
Prescription: Fructus Ligustri Lucidi 20 parts, Radix Rehmanniae Preparata 15 parts, Semen Cuscutae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, Serissa foetida 16 parts, Radix Stellariae Yunnanensis 15 parts, Herba Leonuri 10 parts, Galeola faberi Rolfe. 7 parts, old next blue or green 18 parts, Folium Mahoniae 20 parts.
Preparation method: described Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., always next blue or green, Folium Mahoniae are mixed in prescription ratio, add the water relative to mixture quality 4 ~ 10 times, decoct 2 ~ 3 hours, filter acquisition first extracting solution; The medicinal residues that filtration obtains add the water relative to described medicinal residues quality 2 ~ 4 times again, decoct 1 ~ 2 hour, filter acquisition second extracting solution; First extracting solution and the second extracting solution are merged, adding ethanol makes alcohol content be 30%v/v, leave standstill after 24 hours, obtain supernatant, then be the ultrafiltration post ultrafiltration of 7500-9000 through the molecular weight that dams, ultrafiltrate subtracts and is concentrated into relative density 1.05-1.10 (60 DEG C record), inlet temperature 140 ~ 150 DEG C, carry out spraying dry under leaving air temp 75 ~ 80 DEG C of conditions, obtain active constituents of medicine, make according to galenic pharmacy routine techniques.
The present embodiment capsule, every containing crude drug 0.7g.
Embodiment 2 capsule
Prescription: Fructus Ligustri Lucidi 16 parts, Radix Rehmanniae Preparata 13 parts, Semen Cuscutae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Serissa foetida 12 parts, Radix Stellariae Yunnanensis 20 parts, Herba Leonuri 7 parts, Galeola faberi Rolfe. 5 parts, old next blue or green 20 parts, Folium Mahoniae 15 parts.
Preparation method: with reference to embodiment 1.
Embodiment 3 capsule
Prescription: Fructus Ligustri Lucidi 15 parts, Radix Rehmanniae Preparata 10 parts, Semen Cuscutae 10 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, Serissa foetida 12 parts, Radix Stellariae Yunnanensis 15 parts, Herba Leonuri 6 parts, Galeola faberi Rolfe. 5 parts, old next blue or green 12 parts, Folium Mahoniae 10 parts.
Preparation method: with reference to embodiment 1.
Embodiment 4 capsule
Prescription: Fructus Ligustri Lucidi 21 parts, Radix Rehmanniae Preparata 18 parts, Semen Cuscutae 13 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Serissa foetida 15 parts, Radix Stellariae Yunnanensis 20 parts, Herba Leonuri 12 parts, Galeola faberi Rolfe. 8 parts, old next blue or green 13 parts, Folium Mahoniae 16 parts.
Preparation method: with reference to embodiment 1.
Embodiment 5 capsule
Prescription: Fructus Ligustri Lucidi 20 parts, Radix Rehmanniae Preparata 12 parts, Semen Cuscutae 18 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, Serissa foetida 18 parts, Radix Stellariae Yunnanensis 30 parts, Herba Leonuri 8 parts, Galeola faberi Rolfe. 9 parts, old next blue or green 15 parts, Folium Mahoniae 25 parts.
Preparation method: with reference to embodiment 1.
Embodiment 6 capsule
Prescription: Fructus Ligustri Lucidi 15 parts, Radix Rehmanniae Preparata 20 parts, Semen Cuscutae 18 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Serissa foetida 16 parts, Radix Stellariae Yunnanensis 20 parts, Herba Leonuri 10 parts, Galeola faberi Rolfe. 5 parts, old next blue or green 15 parts, Folium Mahoniae 21 parts.
Preparation method: with reference to embodiment 1.
Embodiment 7 granule
Prescription: Fructus Ligustri Lucidi 18 parts, Radix Rehmanniae Preparata 15 parts, Semen Cuscutae 13 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Serissa foetida 16 parts, Radix Stellariae Yunnanensis 18 parts, Herba Leonuri 10 parts, Galeola faberi Rolfe. 7 parts, old next blue or green 25 parts, Folium Mahoniae 16 parts.
Preparation method: described Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., always next blue or green, Folium Mahoniae are mixed in prescription ratio, add the water relative to mixture quality 4 ~ 10 times, decoct 2 ~ 3 hours, filter acquisition first extracting solution; The medicinal residues that filtration obtains add the water relative to described medicinal residues quality 2 ~ 4 times again, decoct 1 ~ 2 hour, filter acquisition second extracting solution; First extracting solution and the second extracting solution are merged, adding ethanol makes alcohol content be 30%v/v, leave standstill after 24 hours, obtain supernatant, then be the ultrafiltration post ultrafiltration of 7500-9000 through the molecular weight that dams, ultrafiltrate subtracts and is concentrated into relative density 1.05-1.10 (60 DEG C record), inlet temperature 140 ~ 150 DEG C, carry out spraying dry under leaving air temp 75 ~ 80 DEG C of conditions, obtain active constituents of medicine, make according to galenic pharmacy routine techniques.
The present embodiment granule, every bag containing crude drug 3.0g.
Embodiment 8 tablet
Prescription: Fructus Ligustri Lucidi 18 parts, Radix Rehmanniae Preparata 13 parts, Semen Cuscutae 18 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Serissa foetida 15 parts, Radix Stellariae Yunnanensis 20 parts, Herba Leonuri 10 parts, Galeola faberi Rolfe. 7 parts, old next blue or green 18 parts, Folium Mahoniae 20 parts.
Preparation method: described Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., always next blue or green, Folium Mahoniae are mixed in prescription ratio, add the water relative to mixture quality 4 ~ 10 times, decoct 2 ~ 3 hours, filter acquisition first extracting solution; The medicinal residues that filtration obtains add the water relative to described medicinal residues quality 2 ~ 4 times again, decoct 1 ~ 2 hour, filter acquisition second extracting solution; First extracting solution and the second extracting solution are merged, adding ethanol makes alcohol content be 30%v/v, leave standstill after 24 hours, obtain supernatant, then be the ultrafiltration post ultrafiltration of 7500-9000 through the molecular weight that dams, ultrafiltrate subtracts and is concentrated into relative density 1.05-1.10 (60 DEG C record), inlet temperature 140 ~ 150 DEG C, carry out spraying dry under leaving air temp 75 ~ 80 DEG C of conditions, obtain active constituents of medicine, make according to galenic pharmacy routine techniques.
The present embodiment tablet, every sheet contains crude drug 0.5g.
Embodiment 9 clinical observation is tested
1 data and method
1.1 case selection
1.1.1 Western medicine diagnose standard: the standard formulated in the PCOS seminar that 2003 combine initiation in Rotterdam with reference to European human reproduction association and reproduction association of the U.S.: (1) accidental ovulation and (or) anovulatory symptom, irregular menstruation (rare, amount less, amenorrhea, anovulatory dysfunctional uterine hemorrhage); (2) there is the performance of hyperandrogenism: clinical (comprise acne, hirsutism, bald) and (or) biochemical indicator (get rid of adrenal,congenital hyperplasia, the factor that the tumor that secretes androgen and Cushing syndrome etc. may be caused a disease; (3) B ultrasonic prompting bilateral ovaries polycystic change: bilateral ovaries volume increases, respectively have >=10 diameters are at the little follicle of 2 ~ 8mm.(the menolipsis person of rising all detects without during dominant follicle in B ultrasonic prompting bilateral ovaries).More than possess any two or more person, and within nearly 3 months, do not use steroid hormone class medicine person.
1.1.2 Standards of Chinese Medical Syndrome Differentiation: for meeting above-mentioned Western medicine diagnose standard person, " Chinese medical disease Standardization of diagnosis and curative effect " and " new Chinese medicine guideline of clinical investigations " with reference to State Administration of Traditional Chinese Medicine's promulgation in 1994 belongs to liver-kidney yin deficiency.
Primary symptom: menstrual cycle shifts to an earlier date or delays; Hypomenorrhea or amenorrhea; Dysphoria with feverish sensation in the chest palms and soles; Dizziness and tinnitus; Soreness of the waist and knees;
Secondary disease: breast side of body distending pain of the breast; Facial acne; Hirsutism; Month red menses, matter is thick; Irascible temperament; Bitter taste in the mouth and dry throat; Constipation with dry stool;
Tongue arteries and veins: red tongue or dark red, less fur or Huang; Thready and rapid pulse or stringy and rapid pulse.
Primary symptom must possess, and secondary disease needs possesses 1-2 item, and with reference to typical tongue arteries and veins performance, syndrome of yin deficiency of liver and kidney is both diagnosable.
Tcm symptom is marked: cardinal symptom standards of grading are with reference to " tcm clinical practice Illnesses Diagnoses criterion of therapeutical effect ", and primary symptom and secondary disease are by nothing, slight, moderate, severe 0,1,2,3 point respectively.
From plan standards of grading: every sign is carried out scoring and added up, and 0-10 is divided into slightly; 11-19 is divided into moderate; Running summary of the points scored person more than 20 points is severe.
1.1.3 case inclusive criteria: meet above-mentioned diagnostic criteria person; Voluntary participation treatment also can regular further consultation person.
1.1.4 case exclusion standard: the dialectical person that do not meet syndrome of yin deficiency of liver and kidney; There is other endocrinopathyes, as the person such as congenital adrenal cortical hyper plasia, Cushing's syndrome, ovary or adrenal gland neoplasms, high prolactin hyperandrogenism, diabetes; Nearly 3 months with crossing hormone medicine person; Allergic constitution or those who are allergic to this drug; Meet inclusive criteria, but do not take medicine by regulation, cannot judge that curative effect or data carry out therapeutic evaluation persons completely without method.
1.2 physical data: select in January, 2014 to 2014 my institute's Out-patient Clinic of Department of Gynecology of year December be diagnosed as PCOS patient 108 example, the age, between 18 ~ 35 years old, by random digits table, is divided into two groups at random.Western medicine group 36 example, the mean age (23.8 ± 2.6) year; The course of disease 6 months ~ 4 years, average (1.65 ± 0.62) year.Chinese drug-treated group 72 example, the mean age (24.2 ± 2.8) year; The course of disease 6 months ~ 4 years, average (1.62 ± 0.60) year.Two groups of physical data compare no difference of science of statistics (P > 0.05), have comparability.
1.3 Therapeutic Method
Western medicine group: (every sheet is containing cyproterone acetate 2mg and ethinylestradiol 35 μ g to start oral Diane-35 on the 5th day in natural menstrual or withdrawal bleeding, Schering Corp of Germany produces), every day 1, serve on 21d, withdrawal bleeding the 5th day lifting taking another dose use is treated, totally 3 cycles after drug withdrawal.
Chinese drug-treated group: capsule prepared by the oral embodiment of the present invention 1, every day 2 times, each 2-4 grain, takes after meal half an hour, and a menstrual cycle is a course for the treatment of, meets stop using menstrual period, treats 3 courses for the treatment of altogether.
1.4 observation index:
1.4.1 before observing treatment, after treatment 3 all after dates and drug withdrawal, the menstruation of the 3rd cycle patient improves situation (main inquiry patient menstrual is risen the time, menstrual blood volume, color, matter situation), and ovulation situation and B ultrasonic measure uterus size;
1.4.2 observe treatment before, treatment 3 all after dates and drug withdrawal after the 3rd cycle patient tcm symptom scoring situation;
1.4.3 liver function level is detected before and after treatment, to observe the toxicity situation of two groups.
1.5 criterions of therapeutical effect: work out with reference to " new Chinese medicine guideline of clinical investigations " standard.Effective: menstrual cycle recovers normal, in menstruation rule 3 cycles of > continuously after drug withdrawal, clinical symptoms obviously alleviates, basal body temperature two-phase, and physiological hormone level is normal, and B ultrasonic prompting ovary recovers normal size; Effective: menstrual cycle recovers normal substantially, after drug withdrawal, 3 cycle state of an illness occasionally have recurrence, and clinical symptoms alleviates to some extent, and physiological hormone level is tending towards normal, and B ultrasonic prompting ovary reduces before comparatively treating to some extent; Invalid: menoxenia, even still amenorrhea, clinical symptoms and physiological hormone level are not improved, and ultrasound diagnosis is not improved.Total effective rate=(effective number of cases+effectively number of cases)/total number of cases × 100%.
1.6 statistical methods: adopt SPSS15.0 statistical software to calculate.Each numerical value with
represent, measurement data adopts t inspection, and enumeration data adopts χ
2inspection, with P < 0.05 for difference has statistical significance.
2 results
2.1 liang of group patient polycystic ovarian syndrome comparitive study: effective 42 examples of Chinese drug-treated group after treatment, effective 28 examples, invalid 2 examples, obvious effective rate 58.3%, total effective rate 97.2%; Effective 12 examples of Western medicine group, effective 16 examples, invalid 8 examples, obvious effective rate 33.3%, total effective rate 77.8%, Chinese drug-treated group compares with Western medicine group obvious effective rate, total effective rate, and difference has statistical significance (P < 0.05), illustrates that Chinese drug-treated group significantly can improve clinical cure rate and the obvious effective rate of Polycystic Ovary Syndrome in Adolescence patient compared with Western medicine group.In table 1.
Table 1 liang group patient comparitive study (n%, example)
Note: compare with Western medicine group, * P < 0.05.
TCM symptom score compares before and after 2.2 liang of group treatments and after drug withdrawal: after treatment, two groups of TCM symptom scores are all than obviously less before treatment, have statistical significance (P < 0.01) with comparing difference before treatment; Compare between two groups after treatment, observation group is improving dysphoria with feverish sensation in the chest palms and soles, dizziness and tinnitus, the aspects such as soreness of the waist and knees are better than Western medicine group, observation group's symptom integral reduces more obvious, the 3rd cycle after drug withdrawal, and Western medicine group symptom integral returns to again the front level for the treatment of, Chinese drug-treated group still keeps the level (P < 0.01) after treating, and comparatively Western medicine group declines obviously (P < 0.01) same period.In table 2.
After a table 2 liang group treats front and back and drug withdrawal, TCM symptom score compares
Note: compare with before treatment, * P < 0.01, compares with Western medicine group the same period,
#p < 0.01.
Ultrasound diagnosis index change before and after 2.3 liang of group treatments: ultrasound diagnosis Indexes Comparison no significant difference before two groups of treatments, after treating 3 cycles, the uterine volume of patient has no significant change (P > 0.05), and endometrium thickness, bilateral ovaries volume all obviously reduce (P < 0.01).3rd cycle after drug withdrawal, the indices that Western medicine group patient B surpasses inspection returns to again the situation before treatment substantially, Chinese drug-treated group still keeps situation (P < 0.01) after the treatment, and endometrium thickness, bilateral ovaries volume comparatively Western medicine group all obviously reduce (P < 0.01) same period.
In the patient of 2.4 side reaction Western medicine group treatments, feeling sick appears in 8 routine patients, and the gastrointestinal reactions such as flatulence, take a turn for the better after symptomatic treatment; There is distending pain of the breast in 5 examples, the moon is premenstrual more obvious; Chinese drug-treated group does not tell discomfort, and two groups are compared, and difference has statistical significance (P < 0.01).
Claims (10)
1. treat a pharmaceutical composition for liver-kidney yin deficiency polycystic ovarian syndrome, it is characterized in that by Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., old come the ten taste crude drug such as blue or green, Folium Mahoniae make.
2. the pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome as claimed in claim 1, is characterized in that being made up of the crude drug of following weight: Fructus Ligustri Lucidi 13-26 part, Radix Rehmanniae Preparata 10-20 part, Semen Cuscutae 6-26 part, Radix Et Caulis Acanthopanacis Senticosi 5-15 part, Serissa foetida 10-20 part, Radix Stellariae Yunnanensis 10-30 part, Herba Leonuri 5-15 part, Galeola faberi Rolfe. 5-15 part, old next blue or green 10-25 part, Folium Mahoniae 10-25 part.
3. the pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome as claimed in claim 2, is characterized in that being made up of the crude drug of following weight: Fructus Ligustri Lucidi 16-21 part, Radix Rehmanniae Preparata 12-17 part, Semen Cuscutae 13-18 part, Radix Et Caulis Acanthopanacis Senticosi 8-13 part, Serissa foetida 13-18 part, Radix Stellariae Yunnanensis 15-20 part, Herba Leonuri 7-12 part, Galeola faberi Rolfe. 5-9 part, old next blue or green 13-18 part, Folium Mahoniae 16-21 part.
4. the pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome as claimed in claim 3, is characterized in that being made up of the crude drug of following weight: Fructus Ligustri Lucidi 20 parts, Radix Rehmanniae Preparata 15 parts, Semen Cuscutae 15 parts, Radix Et Caulis Acanthopanacis Senticosi 8 parts, Serissa foetida 16 parts, Radix Stellariae Yunnanensis 15 parts, Herba Leonuri 10 parts, Galeola faberi Rolfe. 7 parts, old next blue or green 18 parts, Folium Mahoniae 20 parts.
5. the pharmaceutical composition of the treatment liver-kidney yin deficiency polycystic ovarian syndrome as described in as arbitrary in claim 1-4, is characterized in that described pharmaceutical composition is preferably made for peroral dosage form.
6. the pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome according to claim 5, is characterized in that described peroral dosage form is tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, pulvis, sublimed preparation, solution etc.
7. the pharmaceutical composition for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome according to claim 6, is characterized in that described peroral dosage form is preferably capsule, tablet, granule; Most preferably be capsule.
8. the pharmaceutical composition of the treatment liver-kidney yin deficiency polycystic ovarian syndrome as described in as arbitrary in claim 1-4, it is characterized in that preparation method comprises the steps: described Fructus Ligustri Lucidi, Radix Rehmanniae Preparata, Semen Cuscutae, Radix Et Caulis Acanthopanacis Senticosi, Serissa foetida, Radix Stellariae Yunnanensis, Herba Leonuri, Galeola faberi Rolfe., always next blue or green, Folium Mahoniae to mix in prescription ratio, add the water relative to mixture quality 4 ~ 10 times, decoct 2 ~ 3 hours, filter acquisition first extracting solution; The medicinal residues that filtration obtains add the water relative to described medicinal residues quality 2 ~ 4 times again, decoct 1 ~ 2 hour, filter acquisition second extracting solution; First extracting solution and the second extracting solution are merged, adding ethanol makes alcohol content be 30%v/v, leave standstill after 24 hours, obtain supernatant, be the ultrafiltration post ultrafiltration of 7500-9000 again through the molecular weight that dams, ultrafiltrate subtracts and is concentrated into relative density 1.05-1.10 (60 DEG C record), inlet temperature 140 ~ 150 DEG C, carry out spraying dry under leaving air temp 75 ~ 80 DEG C of conditions, obtain active constituents of medicine; This composition is independent or mix with medicine acceptable carrier, makes pharmaceutical composition of the present invention according to galenic pharmacy routine techniques.
9. the purposes of the pharmaceutical composition as described in as arbitrary in claim 1-4 in the medicine for the treatment of liver-kidney yin deficiency polycystic ovarian syndrome.
10. the purposes of the pharmaceutical composition as described in as arbitrary in claim 1-4 in the medicine for the treatment of polycystic ovarian syndrome.
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