CN105362647A - Method for preparing pharmaceutical composition for treating gynecological hemorrhage syndrome - Google Patents
Method for preparing pharmaceutical composition for treating gynecological hemorrhage syndrome Download PDFInfo
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Abstract
The invention relates to a method for preparing a pharmaceutical composition for treating a gynecological hemorrhage syndrome, and belongs to the technical field of traditional Chinese medicines. The method for preparing the pharmaceutical composition for treating gynecological hemorrhage syndrome comprises the following steps: weighing the following raw materials: Radix Ophiopogonis, semen cuscutae, herba leonuri, Astragalus membranaceus, poria cocos, rhizoma cyperi, Artemisia anomala, polygala tenuifolia, Angelica sinensis, fructus lycii, hawthorn and liquorice; respectively treating the raw materials; cleaning, drying, pulverizing, extracting, filtering and concentrating to obtain extracts; merging the extracts; drying, pulverizing and sieving; and preparing into a required traditional Chinese medicine preparation by using the modern general preparation technology. The pharmaceutical composition further has the advantages of stable efficacy, simple preparation technology, low cost, easiness in promotion and application, and the like. In addition, medicinal materials and dose of the pharmaceutical composition prepared by the invention are compatible scientifically; and the pharmaceutical composition has effects of restraining and stopping bleeding, regulating menstruation and relieving pain, nourishing the liver and the kidney and the like, is used for treating gynecological hemorrhage syndrome clinically, and has the advantages of remarkable curative effect, capability of effectively relieving pain of patients, low side effects, capability of treating both symptoms and root causes, and the like.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to a kind of method preparing the pharmaceutical composition for the treatment of gynecological bleeding disease.
Background technology
Hemorrhage is the large disease of gynecological one, and women take blood as this, through, pregnant, produce, cotton-padded mattress all with blood for.Through the impact of many factors; through, pregnant, produce time; often can there is the bleeding of some exceptions; be referred to as " hemorrhagic disease ", as hemorrhage after preceeded menorrhea, menorrhagia, menostaxis, dysfunctional uterine hemorrhage, hemorrhage due to placement of IUD, artificial abortion, postpartum subinvolution of uterus, Endometrial Hyperplasia is hemorrhage, hysteromyoma hemorrhage, ovarian cyst are hemorrhage.
The method of current treatment gynecological bleeding comprises Drug therapy, operative treatment, radiotherapy etc., and hormone medicine is taken or injected to its drug treatment more, the hormonal readiness of women can be caused disorderly, cause the untoward reaction such as osteoporosis, obesity; There is larger side effect in radiotherapy, does not generally adopt easily; Operative treatment comprises lasertron Endometrium Excision, endoscope's electric power Endometrium excision, uterectomy etc., but be generally applicable to specific crowd, such as, the general hemorrhage not good married patients for the treatment of or first visit person, above treatment means all has some limitations.
Chinese patent application 200910248627.8 discloses a kind of compound Chinese medicinal preparation of prevention and therapy gynecological hemorrhagic disease, and it mainly comprises following raw materials: Os Sepiae, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, Radix Cyathulae, the Radix Astragali and Radix Glycyrrhizae.This Chinese medicine composition has hemostasis, changes the effect of silt, QI invigorating, but animal experiment finds that it focuses on hemostasis, cures the symptoms, not the disease.
Treatment by Chinese herbs gynecological bleeding disease have action temperature and, treating both the principal and secondary aspects of a disease, the features such as onset is lasting, in conjunction with modern Chinese medicine theory of development, carry out to Chinese medicine ingredients the compatibility screening extraction and science, seek a kind of efficacy stability, side effect is low, the Chinese medicine composition for the treatment of gynecological bleeding disease evident in efficacy, has very important clinical meaning.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of gynecological bleeding disease, this pharmaceutical composition has menstruction regulating and pain relieving, enrich blood invigorate blood circulation, effect of the aspect such as nourishing the liver and kidney, possess therapeutic effect significantly, efficacy stability, side effect is low, preparation technology is simple and be easy to advantages such as applying.
Pharmaceutical composition of the present invention is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 10-20 part, Semen Cuscutae 10-20 part, Herba Leonuri 10-18 part, Radix Astragali 8-16 part, Poria 8-12 part, Rhizoma Cyperi 6-14 part, Herba Artemisiae Anomalae 6-12 part, Radix Polygalae 8-14 part, Radix Angelicae Sinensis 6-10 part, Fructus Lycii 4-6 part, Fructus Crataegi 2-6 part and Radix Glycyrrhizae 2-6 part.
Preferably, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 10 parts, Semen Cuscutae 10 parts, Herba Leonuri 10 parts, the Radix Astragali 8 parts, 8 parts, Poria, Rhizoma Cyperi 6 parts, Herba Artemisiae Anomalae 6 parts, Radix Polygalae 8 parts, Radix Angelicae Sinensis 6 parts, Fructus Lycii 4 parts, Fructus Crataegi 2 parts and 2 parts, Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 20 parts, Semen Cuscutae 20 parts, Herba Leonuri 18 parts, the Radix Astragali 16 parts, 12 parts, Poria, Rhizoma Cyperi 14 parts, Herba Artemisiae Anomalae 12 parts, Radix Polygalae 14 parts, Radix Angelicae Sinensis 10 parts, Fructus Lycii 6 parts, Fructus Crataegi 6 parts and 6 parts, Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 14 parts, Semen Cuscutae 14 parts, Herba Leonuri 14 parts, the Radix Astragali 12 parts, 10 parts, Poria, Rhizoma Cyperi 10 parts, Herba Artemisiae Anomalae 8 parts, Radix Polygalae 10 parts, Radix Angelicae Sinensis 8 parts, Fructus Lycii 4 parts, Fructus Crataegi 4 parts and 4 parts, Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 15 parts, Semen Cuscutae 15 parts, Herba Leonuri 16 parts, the Radix Astragali 14 parts, 11 parts, Poria, Rhizoma Cyperi 8 parts, Herba Artemisiae Anomalae 10 parts, Radix Polygalae 11 parts, Radix Angelicae Sinensis 6 parts, Fructus Lycii 5 parts, Fructus Crataegi 6 parts and 5 parts, Radix Glycyrrhizae.
Source, the nature and flavor of pharmaceutical composition of the present invention Chinese crude drug used, return through and effect:
Radix Ophiopogonis: this product is the dried root of liliaceous plant Radix Ophiopogonis (dwarf lilyturf); Sweet in the mouth, micro-hardship, cold nature; GUIXIN, lung, stomach warp; YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.
Semen Cuscutae: this product is the dry mature seed of convolvulus cuscuta plant; Sweet in the mouth, warm in nature; Return liver,kidney,spleen warp; Nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.
Herba Leonuri: this product is the fresh of labiate Herba Leonuri or dry aerial parts; Bitter in the mouth, pungent, cold nature; Return liver, pericardium channel; Promoting blood flow to regulate menstruation, inducing diuresis to remove edema.
The Radix Astragali: this product is the root of leguminous plant Radix Hedysari multijugi; Sweet in the mouth, warm in nature; GUIXIN, lung, spleen, kidney channel; Invigorating QI to consolidate the body surface resistance, diuresis, expelling pus and toxin by strengthening QI, promoting tissue regeneration and ulcer healing.
Poria: this product is the dry sclerotia of On Polyporaceae Poria; Sweet in the mouth, light, property is put down; GUIXIN, lung, spleen, kidney channel; Promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.
Rhizoma Cyperi: this product is the dry rhizome of sedge dried tuber; Acrid in the mouth, micro-hardship, micro-sweet, property is put down; Return liver, spleen, tri-jiao channel; Promoting QI circulation for relieving depression, menstruction regulating and pain relieving.
Herba Artemisiae Anomalae: this product is the herb of feverfew artemisia anomalas; Bitter in the mouth, warm in nature; GUIXIN, spleen channel; Removing blood stasis stimulates the menstrual flow, healing up sore and subduing swelling.
Radix Polygalae: this product is the dry root of milk wort Radix Polygalae or ovum leaf Radix Polygalae; Bitter in the mouth, pungent, warm in nature; GUIXIN, kidney, lung meridian; To calm the nerves Fructus Alpiniae Oxyphyllae, eliminate the phlegm, detumescence.
Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica; Sweet in the mouth, pungent, warm in nature; Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.
Fructus Lycii: this product is the dry mature fruit of plant of Solanaceae Lycium barbarum L.; Sweet in the mouth, property is put down; Return liver, kidney channel; Nourishing the liver and kidney, replenishing vital essence to improve eyesight.
Fructus Crataegi: this product is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae or Fructus Crataegi; Sour in the mouth, sweet, slightly warm in nature; Return spleen, stomach, Liver Channel; Promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.; Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of medicament composing prescription of the present invention:
Medicament composing prescription of the present invention with Herba Leonuri and Semen Cuscutae for monarch drug, promoting blood flow to regulate menstruation, nourishing the liver and kidney; With Radix Ophiopogonis, the Radix Astragali, Poria, Rhizoma Cyperi for ministerial drug, YIN nourishing and the production of body fluid promoting, invigorating QI to consolidate the body surface resistance, menstruction regulating and pain relieving; With Herba Artemisiae Anomalae, Radix Polygalae, Radix Angelicae Sinensis, Fructus Lycii and Fructus Crataegi for adjuvant drug, Fructus Alpiniae Oxyphyllae of calming the nerves, enriches blood and invigorates blood circulation, the kidney invigorating arresting seminal emission; With Radix Glycyrrhizae for making medicine, warming middle-JIAO, removing toxic substances, coordinating the actions of various ingredients in a prescription, makes all medicines arrange in pairs or groups, synergism, jointly reach hold back blood hemostasis, menstruction regulating and pain relieving, enrich blood invigorate blood circulation, effect of the aspect such as nourishing the liver and kidney, to gynecological bleeding disease, there is very significant therapeutic effect.
In addition, the present invention also provides corresponding preparation method to be made and facilitate easy-to-use finished product preparation under the prerequisite ensureing curative effect by this pharmaceutical composition.
The present invention discloses the preparation method of the pharmaceutical composition of above-mentioned treatment gynecological bleeding disease, comprises the following steps:
S1: get Radix Ophiopogonis and clean, crushed after being dried, cross 60-80 mesh sieve, the coarse powder obtained is placed in supercritical carbon dioxide extraction apparatus, the 30-45% volume fraction adding coarse powder weight is the ethanol of 60-85%, regulation and control carbon dioxide flow is 15-20L/h, extracting pressure is 15-20MPa, and extraction temperature is 40-60 DEG C, and extraction time is 1.5-2h, decompression separation obtains Radix Ophiopogonis extract, retains residue Radix Ophiopogonis;
S2: get Semen Cuscutae, Herba Leonuri, the Radix Astragali, Poria, Rhizoma Cyperi, Herba Artemisiae Anomalae and Radix Polygalae, clean, crushed after being dried, merge residue Radix Ophiopogonis, adding medical material gross weight 12-18 times amount volume fraction is the ethanol of 60-80%, microwave extraction 8-15 minute, microwave power is 400-600W, and Extracting temperature is 40-60 DEG C, filters and retains filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.20, obtained extract A;
S3: get Radix Angelicae Sinensis, Fructus Lycii, Fructus Crataegi and Radix Glycyrrhizae, clean, crushed after being dried, merges with the medicinal residues in S2, adds the water soaking 30-60 minute of medical material gross weight 8-12 times amount, reflux, extract, 2-3 time, each 3-5 hour, filters, merging filtrate, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.20, obtained extract B;
S4: merge Radix Ophiopogonis extract, extract A and extract B, drying under reduced pressure, pulverizes, and crosses 80-100 mesh sieve, to obtain final product.
Preferably, described pharmaceutical composition is oral liquid, syrup, granule or powder.
The present invention also discloses the purposes of aforementioned pharmaceutical compositions in treatment gynecological bleeding disease.
Compared with prior art, pharmaceutical composition of the present invention has following technical advantage:
(1) pharmaceutical composition of the present invention is natural Chinese medicines preparation, and toxic and side effects is little, can avoid or reduce the untoward reaction of medicine, is applicable to the treatment of various gynecological bleeding disease.
(2) Chinese medicine composition medical material of the present invention and dose compatibility science; significantly can shorten the mice docking bleeding time; accelerate blood coagulation; data show that Chinese medicine composition of the present invention obviously can improve the clinical symptoms such as dysfunctional uterine hemorrhage, Endometrial Hyperplasia is hemorrhage, postpartum hemorrhage, hysteromyoma hemorrhage, ovarian cyst are hemorrhage clinically, are conducive to protection and maintain the normal uterine function of patient.
(3) pharmaceutical composition of the present invention also has efficacy stability, preparation technology is simple, cost is low and be easy to advantages such as applying.
Detailed description of the invention
Below will the present invention is described further by specific embodiment, it will be understood by those skilled in the art that the present invention also can make other similar changes and obtains similar result and do not depart from content of the present invention and scope except following examples.
embodiment 1
The embodiment of the present invention 1 pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight:
Radix Ophiopogonis 10 parts, Semen Cuscutae 10 parts, Herba Leonuri 10 parts, the Radix Astragali 8 parts, 8 parts, Poria, Rhizoma Cyperi 6 parts, Herba Artemisiae Anomalae 6 parts, Radix Polygalae 8 parts, Radix Angelicae Sinensis 6 parts, Fructus Lycii 4 parts, Fructus Crataegi 2 parts and 2 parts, Radix Glycyrrhizae.
Preparation method is as follows:
S1: get Radix Ophiopogonis and clean, crushed after being dried, cross 60 mesh sieves, the coarse powder obtained is placed in supercritical carbon dioxide extraction apparatus, 45% volume fraction adding coarse powder weight is the ethanol of 75%, regulation and control carbon dioxide flow is 20L/h, extracting pressure is 20MPa, and extraction temperature is 60 DEG C, and extraction time is 1.5h, decompression separation obtains Radix Ophiopogonis extract, retains residue Radix Ophiopogonis;
S2: get Semen Cuscutae, Herba Leonuri, the Radix Astragali, Poria, Rhizoma Cyperi, Herba Artemisiae Anomalae and Radix Polygalae, clean, crushed after being dried, merge residue Radix Ophiopogonis, adding medical material gross weight 12 times amount volume fraction is the ethanol of 60%, microwave extraction 8 minutes, microwave power is 400W, and Extracting temperature is 40 DEG C, filters and retains filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10, obtained extract A;
S3: get Radix Angelicae Sinensis, Fructus Lycii, Fructus Crataegi and Radix Glycyrrhizae, clean, crushed after being dried, merges with the medicinal residues in S2, adds the water soaking 30 minutes of medical material gross weight 8 times amount, reflux, extract, 2 times, each 4 hours, filter, merging filtrate, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10, obtained extract B;
S4: merge Radix Ophiopogonis extract, extract A and extract B, drying under reduced pressure, pulverizes, and crosses 80 mesh sieves, obtains pharmaceutical composition powder;
S5: the pharmaceutical composition fine powder toward S4 adds capsule and commonly uses adjuvant, mixing, and blood pressure lowering dry, pulverize, and crosses 100 mesh sieves, incapsulates in shell, obtain capsule.
embodiment 2
The embodiment of the present invention 2 pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight:
Radix Ophiopogonis 20 parts, Semen Cuscutae 20 parts, Herba Leonuri 18 parts, the Radix Astragali 16 parts, 12 parts, Poria, Rhizoma Cyperi 14 parts, Herba Artemisiae Anomalae 12 parts, Radix Polygalae 14 parts, Radix Angelicae Sinensis 10 parts, Fructus Lycii 6 parts, Fructus Crataegi 6 parts and 6 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 1.
embodiment 3
The embodiment of the present invention 3 pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight:
Radix Ophiopogonis 14 parts, Semen Cuscutae 14 parts, Herba Leonuri 14 parts, the Radix Astragali 12 parts, 10 parts, Poria, Rhizoma Cyperi 10 parts, Herba Artemisiae Anomalae 8 parts, Radix Polygalae 10 parts, Radix Angelicae Sinensis 8 parts, Fructus Lycii 4 parts, Fructus Crataegi 4 parts and 4 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 1.
embodiment 4
The embodiment of the present invention 4 pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight:
Radix Ophiopogonis 15 parts, Semen Cuscutae 15 parts, Herba Leonuri 16 parts, the Radix Astragali 14 parts, 11 parts, Poria, Rhizoma Cyperi 8 parts, Herba Artemisiae Anomalae 10 parts, Radix Polygalae 11 parts, Radix Angelicae Sinensis 6 parts, Fructus Lycii 5 parts, Fructus Crataegi 6 parts and 5 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 1.
pharmaceutical composition pharmacodynamic study of the present invention
test one: pharmaceutical composition of the present invention is on mice docking bleeding time and the impact of clotting time
1, experimental animal: SPF level ICR mice 160, male and female half and half, body weight 22-26g, is divided into 16 groups at random, often organizes 10.
2, test drug and dosage regimen:
Blank group: isometric(al) normal saline gavage every day 1 time, continuous gavage 7 days.
Positive controls: Fuxuekang granules (Guangxi Guixi Pharmaceutical Co., Ltd), becomes the suspension of 65% by water allotment concentration, by dosage gavage every day 1 time of 12g/kg, and successive administration 7 days.
Embodiment 3 high dose group: the pharmaceutical composition that embodiment 3 is obtained, is deployed into water the suspension that concentration is 65%, by dosage gavage every day 1 time of 12g/kg, and successive administration 7 days.
Dosage group in embodiment 3: the pharmaceutical composition that embodiment 3 is obtained, is deployed into water the suspension that concentration is 45%, by dosage gavage every day 1 time of 8g/kg, and successive administration 7 days.
Embodiment 3 low dose group: the pharmaceutical composition that embodiment 3 is obtained, is deployed into water the suspension that concentration is 25%, by dosage gavage every day 1 time of 4g/kg, and successive administration 7 days.
Embodiment 4 high dose group: the pharmaceutical composition that embodiment 4 is obtained, is deployed into water the suspension that concentration is 65%, by dosage gavage every day 1 time of 12g/kg, and successive administration 7 days.
Dosage group in embodiment 4: the pharmaceutical composition that embodiment 4 is obtained, is deployed into water the suspension that concentration is 45%, by dosage gavage every day 1 time of 8g/kg, and successive administration 7 days.
Embodiment 4 low dose group: the pharmaceutical composition that embodiment 4 is obtained, is deployed into water the suspension that concentration is 25%, by dosage gavage every day 1 time of 4g/kg, and successive administration 7 days.
3, test method:
1) mensuration of clotting time of mice: get 8 groups of mices and carry out administration by corresponding dosage regimen, mice last gastric infusion inserts mice side corner of the eyes ball rear vein beard with disposable quantitative blood vessel after 1 hour and gets blood, be full of to capillary glass tube, set level, alternately a bit of from two ends breaking glass capillary tube every 30s, check with or without the appearance of blood clotting silk, fracture from the other end and verify, there is the time of blood clotting silk in average two ends, is clotting time.
2) mensuration in mice docking bleeding time: separately get 8 groups of mices and carry out administration by corresponding dosage regimen, mice last gastric infusion was anaesthetized with pentobarbital sodium after 1 hour, in order to cutting cross-section for Mouse Tail-tip 1/3 place, timing is started when blood overflows voluntarily, drop of blood is sucked once every 30s filter paper, naturally stop (when filter paper is inhaled depletion of blood) until hemorrhage, statistics docking clotting time.
4, result of the test: as shown in table 1.
Table 1 medicine is on the impact of clotting time of mice
Note: compare with blank group,
*p < 0.05,
*p < 0.01,
* *p < 0.001; Compare with positive controls,
#p < 0.05.
From table 1, compare with blank group, positive controls and the embodiment of the present invention 3, the basic, normal, high dosage group of embodiment 4 pharmaceutical composition all significantly can shorten clotting time of mice (P < 0.05), and pharmaceutical composition of the present invention presents good dose-effect relationship; Compare with positive controls, the coagulant blood Be very effective of pharmaceutical composition high dose group of the present invention is better than positive controls (P < 0.05).Above data show, pharmaceutical composition of the present invention has hemostasis effect to mice, and high dose group to urge coagulating effectiveness more excellent.
Table 2 pharmaceutical composition of the present invention is on the impact in docking bleeding time
Note: compare with blank group,
*p < 0.05,
*p < 0.01,
* *p < 0.001; Compare with positive controls,
#p < 0.05.
From table 2, compare with blank group, positive controls and the embodiment of the present invention 3, the high, medium and low dosage group of embodiment 4 pharmaceutical composition all significantly can reduce the mice bleeding time (P < 0.05), and pharmaceutical composition of the present invention presents good dosage effect; Compare with positive controls, the haemostatic effect of pharmaceutical composition high dose group of the present invention is significantly better than positive controls (P < 0.05).Above data show that pharmaceutical composition of the present invention has anastalsis to mice, and high dose group haemostatic effect is more excellent.
test two: the clinical trial of pharmaceutical composition of the present invention
1, subjects basic document
Choose the gynecological bleeding disease clinical volunteers patient that 750 examples meet diagnostic criteria, age 25-50 year, 30 years old mean age, wherein clinical diagnosis is dysfunctional uterine hemorrhage, Endometrial Hyperplasia is hemorrhage, postpartum hemorrhage, ovarian cyst are hemorrhage and each 150 examples of hysteromyoma hemorrhage patient, above all types of gynecological bleeding disease patient is divided into treatment 1 group at random, treats 2 groups and matched group three groups, often organize 50 routine patients.
2, trial drug and test method
Treat 1 group: take capsule prepared by embodiment 3, every capsules drug containing 0.5g, each serving with 2, every day 2 times, takes 10 days continuously.
Treat 2 groups: take capsule prepared by embodiment 4, every capsules drug containing 0.5g, each serving with 2, every day 2 times, takes 10 days continuously.
Matched group: take Fuxuekang granules (Guangxi Guixi Pharmaceutical Co., Ltd), one time 10 grams, 2 times on the one, take 10 days continuously.
3, criterion of therapeutical effect
Settle the standard according to the efficacy determination in " study of tcm new drug guideline ".
Recovery from illness: stop in vaginal hemorrhage 3-5 days after treatment, recovers normal (pass through total amount < 80ml) through amount;
Effective: to stop in vaginal hemorrhage 5-10 days after treatment, before amount comparatively treatment, reduce by 1/3 or < 100ml;
Effective: to stop in vaginal hemorrhage 10 days after treatment, menstrual cycle, all to make moderate progress through amount;
Invalid: treatment after vaginal hemorrhage do not stop, menstrual cycle, through amount be not improved.
4, therapeutic outcome, as shown in table 3.
Table 3 therapeutic effect
5, conclusion (of pressure testing)
Test data shows, pharmaceutical composition of the present invention is as hemorrhage in dysfunctional uterine hemorrhage, Endometrial Hyperplasia for common gynecological bleeding disease, the therapeutic effect of postpartum hemorrhage etc. is remarkable, treat 1 group and be respectively 76% and 74.8% with treatment 2 groups of overall cure rates, treatment total effective rate is respectively 92% and 90.4%, is obviously better than the therapeutic effect of matched group medicine.Clinical test results shows, pharmaceutical composition of the present invention has significant technical advantage in treatment gynecological bleeding disease, can be used as clinical treatment gynecological bleeding disease drug and promotes the use of.
Owing to describing the present invention by above preferred embodiment, in spirit of the present invention and/or scope, any for replacement/of the present invention or combination implement the present invention, be all apparent for a person skilled in the art, and be included among the present invention.
Claims (6)
1. prepare a method for the pharmaceutical composition for the treatment of gynecological bleeding disease, it is characterized in that comprising the following steps:
S1: take following weight portion Chinese crude drug: Radix Ophiopogonis 10-20 part, Semen Cuscutae 10-20 part, Herba Leonuri 10-18 part, Radix Astragali 8-16 part, Poria 8-12 part, Rhizoma Cyperi 6-14 part, Herba Artemisiae Anomalae 6-12 part, Radix Polygalae 8-14 part, Radix Angelicae Sinensis 6-10 part, Fructus Lycii 4-6 part, Fructus Crataegi 2-6 part and Radix Glycyrrhizae 2-6 part for subsequent use; Get Radix Ophiopogonis to clean, crushed after being dried, cross 60-80 mesh sieve, the coarse powder obtained is placed in supercritical carbon dioxide extraction apparatus, the 30-45% volume fraction adding coarse powder weight is the ethanol of 60-85%, regulation and control carbon dioxide flow is 15-20L/h, extracting pressure is 15-20MPa, and extraction temperature is 40-60 DEG C, and extraction time is 1.5-2h, decompression separation obtains Radix Ophiopogonis extract, retains residue Radix Ophiopogonis;
S2: get Semen Cuscutae, Herba Leonuri, the Radix Astragali, Poria, Rhizoma Cyperi, Herba Artemisiae Anomalae and Radix Polygalae, clean, crushed after being dried, merge residue Radix Ophiopogonis, adding medical material gross weight 12-18 times amount volume fraction is the ethanol of 60-80%, microwave extraction 8-15 minute, microwave power is 400-600W, and Extracting temperature is 40-60 DEG C, filters and retains filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.20, obtained extract A;
S3: get Radix Angelicae Sinensis, Fructus Lycii, Fructus Crataegi and Radix Glycyrrhizae, clean, crushed after being dried, merges with the medicinal residues in S2, adds the water soaking 30-60 minute of medical material gross weight 8-12 times amount, reflux, extract, 2-3 time, each 3-5 hour, filters, merging filtrate, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.20, obtained extract B;
S4: merge Radix Ophiopogonis extract, extract A and extract B, drying under reduced pressure, pulverizes, and crosses 80-100 mesh sieve, to obtain final product.
2. the method for the pharmaceutical composition of preparation treatment gynecological bleeding disease as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 10 parts, Semen Cuscutae 10 parts, Herba Leonuri 10 parts, the Radix Astragali 8 parts, 8 parts, Poria, Rhizoma Cyperi 6 parts, Herba Artemisiae Anomalae 6 parts, Radix Polygalae 8 parts, Radix Angelicae Sinensis 6 parts, Fructus Lycii 4 parts, Fructus Crataegi 2 parts and 2 parts, Radix Glycyrrhizae.
3. the method for the pharmaceutical composition of preparation treatment gynecological bleeding disease as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 20 parts, Semen Cuscutae 20 parts, Herba Leonuri 18 parts, the Radix Astragali 16 parts, 12 parts, Poria, Rhizoma Cyperi 14 parts, Herba Artemisiae Anomalae 12 parts, Radix Polygalae 14 parts, Radix Angelicae Sinensis 10 parts, Fructus Lycii 6 parts, Fructus Crataegi 6 parts and 6 parts, Radix Glycyrrhizae.
4. the method for the pharmaceutical composition of preparation treatment gynecological bleeding disease as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 14 parts, Semen Cuscutae 14 parts, Herba Leonuri 14 parts, the Radix Astragali 12 parts, 10 parts, Poria, Rhizoma Cyperi 10 parts, Herba Artemisiae Anomalae 8 parts, Radix Polygalae 10 parts, Radix Angelicae Sinensis 8 parts, Fructus Lycii 4 parts, Fructus Crataegi 4 parts and 4 parts, Radix Glycyrrhizae.
5. the method for the pharmaceutical composition of preparation treatment gynecological bleeding disease as claimed in claim 1, it is characterized in that, described pharmaceutical composition is prepared from by the Chinese crude drug of following parts by weight: Radix Ophiopogonis 15 parts, Semen Cuscutae 15 parts, Herba Leonuri 16 parts, the Radix Astragali 14 parts, 11 parts, Poria, Rhizoma Cyperi 8 parts, Herba Artemisiae Anomalae 10 parts, Radix Polygalae 11 parts, Radix Angelicae Sinensis 6 parts, Fructus Lycii 5 parts, Fructus Crataegi 6 parts and 5 parts, Radix Glycyrrhizae.
6. the method for the pharmaceutical composition of preparation treatment gynecological bleeding disease as claimed in claim 1, is characterized in that: described pharmaceutical composition is oral liquid, syrup, granule or powder.
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