CN100484546C - Compound medicine for treating female disintegration and its production - Google Patents
Compound medicine for treating female disintegration and its production Download PDFInfo
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- CN100484546C CN100484546C CNB2005100300666A CN200510030066A CN100484546C CN 100484546 C CN100484546 C CN 100484546C CN B2005100300666 A CNB2005100300666 A CN B2005100300666A CN 200510030066 A CN200510030066 A CN 200510030066A CN 100484546 C CN100484546 C CN 100484546C
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Abstract
A composite Chinese medicine for treating the profuse bleeding and persistent dripping of woman and other types of internal or external hemorrhage is prepared from 4 Chinese-medicinal materials including hairyvein knotweed root, paleaceous knotweed rhizome, common shamrockpea herb and ovateleaf knotweed rhizome, and the pharmacologically acceptable carrier. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of female disintegration and preparation method thereof.
Background technology
Metrorrhagia is meant menstrual cycle, and menstrual period are through measuring the not normal person of serious disorder.What waterfall was called down when menses were non-collapses the leakage of dripping meaning not to the utmost.Being the common frdquently encountered disease and the difficult disease of gynecological, also is the anxious disease of heavily endangering, and is still the obstinate disease of no treating both the principal and secondary aspects of a disease specific drug so far.Though collapse different with the leakage meaning of a word, right " collapse for leak very, leak for collapse gradually ", so tcm clinical practice is referred to as metrorrhagia, be equivalent to the anovulation anovulatory dysfunctional uterine hemorrhage of doctor trained in Western medicine, exactly so again is the anovulation anovulatory dysfunctional uterine hemorrhage, " being the total symptom that various gynecological diseases shows ".
Also do not have effective Therapeutic Method for metrorrhagia at present, so this area presses for a kind of active drug at metrorrhagia.
Summary of the invention
The present invention aims to provide a kind of pharmaceutical composition, and it can treat metrorrhagia, dysmenorrhea, constitutional or functional amenorrhea and hysteromyoma; Another object of the present invention just provides this preparation of drug combination method.
In one aspect of the invention, a kind of pharmaceutical composition is provided, it contains the necessary component that is selected from down group: 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI, 5-30 parts by weight Radix Polygoni Ciliinerve, and the pharmaceutically acceptable carrier of 50-1000 parts by weight.
In another preference, it contains: 25-45 parts by weight Rhizoma Polygoni Paleachi, 15-35 parts by weight YIKOUXUE, 15-35 parts by weight RHIZOMA POLYGONI SUFFULTI, 10-20 parts by weight Radix Polygoni Ciliinerve.
In another preference, it also contains the medical material Radix Astragali, Radix Ginseng, Radix Codonopsis, Radix Boehmeriae, Ramulus Euonymi, Rhizoma Bistortae, Folium Callicarpae Formosanae and Pollen Typhae carbon etc.
In another aspect of this invention, providing above-mentioned pharmaceutical composition, is suppository, transdermal agent, powder, dissolved granule, pill, oral liquid, tablet or capsule.
In another aspect of this invention, a kind of dietary supplement is provided, it contains the necessary component that is selected from down group: 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI, 5-30 parts by weight Radix Polygoni Ciliinerve, and the pharmaceutically acceptable carrier of surplus.
In another aspect of this invention, a kind of above-mentioned preparation of drug combination method is provided, it comprises step: the medical material of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves or the extract of described medical material are mixed with the pharmaceutically acceptable carrier of 50-1000 parts by weight, obtain pharmaceutical composition.
In above-mentioned preparation method, described extract prepares in order to the below method:
A mixes the medical material of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves;
B is crushed to 90% medical material granule can pass through 20-50 purpose screen cloth, the medical material that obtains pulverizing;
The medical material that c water or 10-90% ethanol extraction are pulverized obtains extract.Wherein ethanol preferred 30-75%.
In another preference, also comprise step: the extract that d drying steps c obtains.
In above-mentioned preparation method, described extract can also prepare in order to the below method:
A obtains extract with Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI, Radix Polygoni Ciliinerve water or 10-90% ethanol extraction respectively; Wherein ethanol preferred 30-75%;
B mixes the medicinal substances extract of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves.
In another preference, described Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI, Radix Polygoni Ciliinerve medical material are that mean diameter is the powder of 5-50 μ m.
In another aspect of this invention, pharmaceutical composition provided by the invention can be used for preparing the medicine of treatment woman uterine bleeding, dysmenorrhea, constitutional or functional amenorrhea or hysteromyoma.
A kind of purposes of mixture also is provided in another aspect of this invention, described mixture is made of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves, and it can be used for preparing the medicine of treatment woman uterine bleeding, dysmenorrhea, constitutional or functional amenorrhea or hysteromyoma.
The precise and appropriate combination of pharmaceutical composition monarch provided by the invention has reached and has cured the effect that metrorrhagia is gynecological's refractory mass formed by blood stasis of primary symptom safely and efficiently.
The specific embodiment
The metrorrhagia pathogenesis that gets to the bottom of sb.'s illness can be divided into the thermic metrorrhagia, and void causes metrorrhagia and the stasis of blood causes metrorrhagia three classes, but the non-single etiology and pathogenesis of its morbidity, but QI and blood being ill simultaneously, how dirty getting involved, cause and effect is relevant, with the passing of time increases the weight of, and is difficult repeatedly.The inventor is through extensive and deep research, this pharmaceutical composition of the present invention is provided, it has clearing away heat and cooling blood concurrently, promoting blood circulation to remove blood stasis, hemostasis analgesic therapy, invigorating the spleen and benefiting QI, the kidney invigorating soothing liver-QI, the effect of YIN nourishing and blood has the hemostasis of the dissipating blood stasis of receipts plug flow, clearing away heat and cooling blood Cheng Yuan, the effect of effecting a permanent cure of spleen invigorating tonify deficiency post-equalization.
For the ease of understanding the present invention, the inventor proposes the possible mechanism of the present composition.Be to be noted that claim scope of the present invention is not subjected to any restriction of this mechanism.Mechanism of the present invention is as follows:
The thermic metrorrhagia has deficiency-heat again, the branch of excess-heat.Deficiency-heat person is the deficiency of YIN often, and cloudy more losing and wound healing are dashed and appointed, so that metrorrhagia is difficult repeatedly, so nourishing YIN and benefiting blood is to control the road that effects a permanent cure that deficiency-heat causes metrorrhagia; The excess-heat person, contrary random catharsis causes Chong and Ren channel disorder; Also have innate excess of YANG in the body, the excess-fire pathogenic heat is compeled and is dashed and appoint; Also having wets holds back heat-transformation, injures to dash and appoints, so heat-clearing and toxic substances removing, cooling blood for hemostasis causes the road that metrorrhagia effects a permanent cure for controlling excess-heat.
Void causes metrorrhagia has the negative and positive of kidney of insufficiency of the spleen, branch, especially the congenital foundation that suffer from a deficiency of the kidney deficient.The disease of metrorrhagia position dash appoint, uterus, belong to kidney so.Tonify deficiency, especially kidney and spleen invigorating are real in controlling the road that effects a permanent cure that void causes metrorrhagia.
The stasis of blood causes the stasis of blood person of the metrorrhagia, and the stasis of blood is a fruit, and because of a lot of, and blood circulation promoting and blood stasis dispelling is to control the road that effects a permanent cure that the stasis of blood causes metrorrhagia.
In sum, though metrorrhagia can be summarized as heat for sick, void, the etiology and pathogenesis of three aspects of the stasis of blood, its non-single etiology and pathogenesis of falling ill, but QI and blood being ill simultaneously, how dirty getting involved, cause and effect is relevant, with the passing of time increases the weight of, and is difficult repeatedly.Must can play the effect of effecting a permanent cure with whole comprehensive improvement so the metrorrhagia opinion is controlled, the pharmaceutical composition that prompting has above-mentioned effect concurrently can effect a radical cure metrorrhagia.
As used herein, term " necessary component " refers to necessary Chinese medicine medical material or its extract, i.e. Rhizoma Polygoni Paleachi (Rhizoma Polygoni Paleacei), YIKOUXUE (Begonia Sinensis A.DC. or BegoniaEvansiana Andr. or Begonia Henryi Hemsl or Begonia Labordei L é vl or Begoniapalatifida Levl or Begonia fimbristipula Hance), RHIZOMA POLYGONI SUFFULTI (Rhizoma PolygoniSuffulti) and Radix Polygoni Ciliinerve (Radix Polygoni Cillinervis).
Rhizoma Polygoni Paleachi is polygonaceae plant Rhizoma Polygoni Paleachi [Polygonum Paleaceum Wall] rhizome.Bitter in the mouth, puckery, slightly warm in nature is returned spleen, stomach, liver, kidney, lung, all warps of large intestine.
YIKOUXUE is the root [Begonia Evansiana Andr.] of Begoniaceae plant Begonia sinensis root [Begonia Sinensis A.DC.] or Begoniaceae plant Flos Begoniae Evansianae etc., bitter in the mouth, and acid, cold nature is returned liver, kidney, lung, large intestine channel.Usage is useful to be decocted in water for oral dose, and also has stewed chicken to take and grind into powder the hot wine clothes person that takes after mixing it with water and steep in wine, and its safety non-toxic is described, edible.
RHIZOMA POLYGONI SUFFULTI is polygonaceae plant RHIZOMA POLYGONI SUFFULTI [Polygonum Suffultum Maxim] rhizome.Bitter in the mouth, puckery, cool in nature, return liver, spleen channel.
Radix Polygoni Ciliinerve is polygonaceae plant floating and thready pulse knotweed { Polygonum Cillinerve (Nakai) Ohwi[Pleuropterus Cillinervis Nakai; Polygonum MultiflorumThunb.Var.Cillinerve (Nakai) Steward] } tuber.Bitter in the mouth, puckery, cool in nature, return lung, large intestine, Liver Channel.
As used herein, term " basically by ... constitute " refer in compositions, except containing neccessary composition or necessary component, also can contain a spot of and not influence the submember and/or the impurity of effective ingredient.For example, can contain sweeting agent to improve taste, antioxidant in case oxidation, and other this areas additive commonly used.Usually Rhizoma Polygoni Paleachi (Rhizoma Polygoni Paleacei), YIKOUXUE (BegoniaSinensis A.DC. or Begonia Evansiana Andr. or Begonia Henryi Hemsl or Begonia Labordei L é vl or Begonia palatifida Levl or Begonia fimbristipulaHance), RHIZOMA POLYGONI SUFFULTI (Rhizoma Polygoni Suffulti) and Radix Polygoni Ciliinerve (Radix PolygoniCillinervis) account at least 70% of whole Chinese medicine medical material weight, preferably at least 80%, more preferably at least 90%.
As used herein, term " pharmaceutically acceptable carrier " refers to be used for the treatment of the carrier of agent administration, comprises various excipient, stabilizing agent, fluidizer and diluent.This term refers to some medicament carriers like this: they itself are not necessary active component, and do not have undue toxicity after using.Suitable carriers is well known to those of ordinary skill in the art.(Mack Pub.Co. can find discussing fully about pharmaceutically acceptable excipient in N.J.1991) at Remington ' s Pharmaceutical Sciences.Acceptable carrier can contain liquid on combination of Chinese medicine is learned, as water, saline, glycerol and ethanol.In addition, also may there be complementary material in these carriers, as wetting agent or emulsifying agent, pH buffer substance etc.Other inessential compositions (for example other complementary medical materials) are also included within the definition of pharmaceutically acceptable carrier.
As used herein, term " compositions of the present invention " comprises pharmaceutical composition and dietary supplement, as long as they contain or basically by (1) Rhizoma Polygoni Paleachi; (2) YIKOUXUE; (3) RHIZOMA POLYGONI SUFFULTI and (4) Radix Polygoni Ciliinerve are formed.Usually, Rhizoma Polygoni Paleachi+YIKOUXUE+RHIZOMA POLYGONI SUFFULTI+Radix Polygoni Ciliinerve weight accounts for the 30-99% of composition total weight, preferably 50-90%, more preferably 60-99%.In preference, the present composition does not contain other contained Chinese medicines in the herbal mixture of treatment metrorrhagia at present usually, and compositions for example of the present invention can also contain following Chinese crude drug or its extract or active component: the Radix Astragali, Radix Ginseng, Radix Codonopsis, Radix Boehmeriae, Ramulus Euonymi, Rhizoma Bistortae, Folium Callicarpae Formosanae and Pollen Typhae carbon etc.
Pharmaceutical composition of the present invention or dietary supplement can be made the dosage form of any routine by conventional method, preferably powder, granule, pill, oral liquid, tablet, capsule preparations, suppository or transdermal agent.
Compositions of the present invention can be used with usual manner, and is for example oral.When making pharmaceutical composition, gross weight by 4 kinds of necessary component homomixtures, usually every day, dosage was at least about 10 grams/50 kg body weight, and in most of the cases be no more than about 150 grams/50 kg body weight, preferably this dosage is about 15 grams/50 kg body weight-Yue 30 grams/50 kg body weight; Divide 1-3 time oral, serve on 3-7 days.The consumption of superfine powder is the 1/3-1/2 of non-superfine powder.Certainly, concrete dosage also should be considered factors such as route of administration, patient health situation, and these all are within the skilled practitioners skill.
On the other hand, the invention provides the method for a kind of pharmaceutical compositions or dietary supplement, it comprises the steps:
A mixes 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves;
B powder process promptly.
In another preference necessary component Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI, Radix Polygoni Ciliinerve are cleaned respectively, dried or dry, ripening, be mixed in proportion, coarse pulverization is to the 30-40 order, water or 10-90% ethanol extraction, vacuum lyophilization or spray drying extract, ultra micro break up to mean diameter 5-50 μ m, conventional pelletize, tabletting or glue capsule etc.Wherein ethanol preferred 30-75%.
Perhaps, 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves are mixed; Coarse pulverization; Water or 10-90% ethanol extraction.Wherein ethanol preferred 30-75%.
In another preference Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI, Radix Polygoni Ciliinerve difference well-established law are extracted; Dry extract is mixed in proportion.
Pharmaceutical composition provided by the invention on the other hand can be used for preparing the medicine of treatment woman uterine bleeding, dysmenorrhea, constitutional or functional amenorrhea or hysteromyoma.
The present invention also provides a kind of mixture that is made of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves to be used to prepare the medicine of treatment woman uterine bleeding, dysmenorrhea, constitutional or functional amenorrhea or hysteromyoma in another preference.
In another preference pharmaceutical composition provided by the invention can be used for preparing hemorrhage such as traumatic hemorrhage, epistaxis, the hemoptysis for the treatment of other position, spit blood, have blood in stool, the medicine of disease such as hematuria.
Major advantage of the present invention is:
1, can effect a radical cure the non-menstruation massive hemorrhage of female genital tract or, the menses more than (disintegration) too much of serious harm WomanHealth even life through measuring;
2, to dysmenorrhea, amenorrhea, leucorrhea with red and white discharge, menoxenia, the disease of the common pilositys of gynecological such as hysteromyoma also has good effect;
3, the hemorrhage disease in other position also there is good effect.。
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, usually according to normal condition, or the condition of advising according to manufacturer.In an embodiment, percentage ratio is weight percentage, and umber is parts by weight, unless stated otherwise.
Embodiment 1-4
Extractum is extracted in preparation
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Rhizoma Polygoni Paleachi | 35 | 15 | 45 | 20 |
| YIKOUXUE | 25 | 15 | 25 | 35 |
| RHIZOMA POLYGONI SUFFULTI | 25 | 15 | 15 | 35 |
| Radix Polygoni Ciliinerve | 15 | 10 | 20 | 25 |
| Radix Astragali | 10 | 10 | 10 | |
| Radix Codonopsis | 10 | |||
| Radix Boehmeriae | 10 | 10 | 10 | |
| Ramulus Euonymi | 10 | 10 | 10 | |
| Folium Callicarpae Formosanae | 10 | 10 | 10 | |
| Solvent (ethanol %) | 0 | 10 | 50 | 70 |
(1) medical material is cleaned respectively, dried or dries, be mixed in proportion;
(2) coarse pulverization is to the 30-40 order, solvent extraction 2 times, each 1 hour;
(3) vacuum lyophilization or spray drying extract.
Embodiment 5-8
The preparation superfine powder
(1) medical material is cleaned respectively, dried or dries, be mixed in proportion;
(2) adopt super micron mill with pulverizing medicinal materials, ultra micro breaks up to particle diameter 5-50 μ m;
(3) irradiation sterilization promptly.
Embodiment 9-12
Useful in preparing drug formulations
Add 40 gram starch, 5 gram methylcellulose, 5 gram magnesium stearate in the superfine powder that 50 gram embodiment 5-8 obtain, tabletting makes tablet.
Embodiment 13
Pharmacodynamics test
1 materials and methods
1.1 be subjected to the reagent thing:
1, embodiment 1 prepared extraction extractum and embodiment 5 prepared superfine powder.Medicine is prepared with distilled water.
2, GONGXUENING JIAONANG: Yunnan Paiyao Group Corp., Ltd produces, and function cures mainly and is cooling blood for hemostasis, removing damp-heat, blood-activating analgetic.Every 1.3g, oral, one time 2,3 times on the one, lot number: 20050303.Medicine is prepared with distilled water.By 4 times of dose,equivalent administrations of people's clinical application, mice 3.6g/kg.
3, bolus of ten powerful tonics, as if the western Pharmacy stock Co., Ltd in Henan produces, function cures mainly and is the temperature compensation QI and blood, a 8-10 ball, three times on the one, per 8 balls are equivalent to crude drug 3g.Lot number 020501.Medicine is prepared with distilled water.By 4 times of dose,equivalent administrations of people's clinical application, rat 3.2g/kg
1.2 main agents and instrument
BP1502, AB204 type electronic balance: METTLER TOLEDO company product.
NXE-1 type cone and plate viscometer: Chengdu Instruement Factory produces.
1.3 laboratory animal
1, a SD system cleaning level rat is by west, Shanghai pul-must provide by triumphant laboratory animal company limited.Credit number: SCXK (Shanghai) 2003-0002, the quality certification number is 0006231.
2, an ICR system cleaning level mice is by west, Shanghai pul-must provide by triumphant laboratory animal company limited.Credit number: SCXK (Shanghai) 2003-0002, the quality certification number is 0002016.
The laboratory animal environmental facility quality certification number: moving No. 027 of Hunan.
1.4 drug dose and preparation
1, extractum preparation: every gram dry extract contains crude drug 6.67g, mouse stomach administration volume is 10ml/kg, small dose group dosage behaviour clinical application dose,equivalent, by people's clinical application amount is 15g/ day, calculate quite be grown up 0.0026 times of (70kg) consumption of mice 20g by body surface area, promptly mice small dose group consumption is 60 * 0.0026=0.156g crude drug/20g mice=7.8g crude drug/kg mice.In, heavy dose is respectively 2 times of people's clinical application dose,equivalent amounts and 4 times of amounts of dose,equivalent, is 15.6,31.2g crude drug/kg.Every 100ml distilled water adds 11.7g, 23.4g and 46.8g extractum respectively.
Press body surface area and calculate quite 0.018 times of adult's (70kg) consumption of rat (200g).The rat dose,equivalent is 60 * 0.018=1.08g crude drug/200g rat=5.4g crude drug/kg rat, and as low dose, middle dosage and high dose are respectively 2 and 4 times of low dosage with dose,equivalent.Little, in, heavy dose is respectively 5.4,10.8,21.6g crude drug/kg.Rat oral gavage administration volume is 10ml/kg, and every 100ml distilled water adds 8.1g, 16.2g and 32.4g extractum respectively.
2, superfine powder preparation: people's dosage is pressed 1/3 amount of extractum and is calculated, and is 5g/ day.The mice medication little, in, heavy dose is respectively 2.6,5.2g, 10.4g crude drug/kg.The rat medication little, in, heavy dose is respectively 1.8,3.6,7.2g crude drug/kg.
1.5 laboratory animal grouping:
1, blank group: animal is irritated stomach and gives distilled water in contrast.
2, model control group: give distilled water in contrast after the animal modeling is good.
3, extract small dose group: animal is irritated the extractum of stomach administration of human clinical application dose,equivalent.
4, dosage group in the extract: animal is irritated the extractum of 2 times of amounts of stomach administration of human clinical application dose,equivalent.
5, the heavy dose of group of extract: animal is irritated the extractum of 4 times of amounts of stomach administration of human clinical application dose,equivalent.
6, superfine powder small dose group: animal is irritated the superfine powder of stomach administration of human clinical application dose,equivalent.
7, dosage group in the superfine powder: animal is irritated the superfine powder of 2 times of amounts of stomach administration of human clinical application dose,equivalent.
8, the heavy dose of group of superfine powder: animal is irritated the superfine powder of 4 times of amounts of stomach administration of human clinical application dose,equivalent.
9, positive controls: animal is irritated stomach and gives corresponding positive control drug.
1.6 statistical analysis technique
Experimental data is represented with mean+SD.The significance of group difference adopts the t check.
2 result of the tests
2.1 to the mice influence in docking bleeding time
Get 80 of ICR system cleaning level mices, male and female half and half, the weight of animals 20.3 ± 1.8g is divided into 8 groups at random, is respectively the blank group; Extract is little, in, heavy dose of group (7.8,15.6,31.2g crude drug/kg); Superfine powder is little, in, heavy dose of group (2.6,5.4,10.8g crude drug/kg); GONGXUENING positive controls (3.6g/kg).Every group of 10 animals are pressed the 10ml/kg gastric infusion, and the blank group gives distilled water, continuous 5 days.Behind the last administration 30min, cut off, treat to begin to clock after blood overflows automatically, inhale to dehematize with filter paper every 30s and drip once, till blood stops (depletion of blood when filter paper is inhaled) naturally, calculate the bleeding time apart from tail point 15mm place.The results are shown in Table 1.
Table 1: to the mice influence (x ± SD n=10) in docking bleeding time
Compare with the blank group: * P＜0.05 * * P＜0.01
By table 1 as seen: extract is little, in, heavy dose of group all can obviously shorten bleeding time of mice, with blank group P＜0.01,0.01,0.01 relatively; Superfine powder is little, in, heavy dose of group all can obviously shorten bleeding time of mice, with blank group P＜0.05,0.05,0.01 relatively.
The heavy dose of group of extract and superfine powder dosage is 4 times to small dose group (clinical treatment group), and the GONGXUENING dosage also is 4 times of clinical consumptions to this medicine description, therefore, the hemorrhage result of the test of mice shows, no matter extract or superfine powder, haemostatic effect all is the trend that is better than GONGXUENING.
2.2 clotting time of mice is influenced
Extract a branch hole ball rapidly with the curved tweezer of ophthalmology behind the above-mentioned mice 1h, promptly have blood to flow out.Each one is bled in the microscope slide two ends, and the about 5mm of blood diameter clocks with stopwatch immediately.Provoke gently inwards 1 time from the drop of blood edge with pin every 30s, observation has or not the blood streak to provoke, and ends to provoking the blood streak from the blood sampling beginning, and the time of being experienced is clotting time.The results are shown in Table 2.
Table 2: to the influence (x ± SD n=10) of clotting time of mice
Compare with the blank group: * P＜0.05 * * P＜0.01
By table 2 as seen: extract is little, in, heavy dose of group all can obviously shorten bleeding time of mice, with blank group P＜0.05,0.01,0.01 relatively; Superfine powder is little, in, heavy dose of group all can obviously shorten bleeding time of mice, with blank group P＜0.05,0.01,0.01 relatively.
The heavy dose of group of extract and superfine powder dosage is 4 times to small dose group (clinical treatment group), and GONGXUENING also is 4 times of clinical consumptions to this medicine description, and therefore, mice hemostasis trial result shows, no matter extract or superfine powder, haemostatic effect all is the visible trend that is better than GONGXUENING.
2.3 influence to the model of qi-asthenia hemorheology of rat
Get 60 of SD rats, male and female half and half, body weight 248 ± 17g is divided into 9 groups at random, is respectively the blank group; The model of qi-asthenia group; Extract is little, in, heavy dose of group (5.4,10.8,21.6g crude drug/kg); Superfine powder is little, in, heavy dose of group (1.8,3.6,7.2g crude drug/kg); Bolus of ten powerful tonics positive controls (3.2g/kg).Every group of 10 animals are pressed the 10ml/kg gastric infusion, and blank group and model of qi-asthenia group give distilled water, continuous 14 days.In experiment beginning in first day, after the administration 40 minutes, except that the normal control group, all the other are respectively organized rat and all put into 43 ± 0.5 ℃ of water temperatures, swim in the tank of depth of water 35cm, and the time that occurs natural subsidence with every rat swims the fatigue proof time for it, when natural subsidence appears in complete group 50% rat, all stop swimming, take out and to put back to separately in the cage, swam continuously for 2 weeks.After the last administration 1 hour, eye socket was got the hematometry hemorheology index, the results are shown in Table 3.
Table 3: to the influence (x ± SD n=10) of model of qi-asthenia hemorheology of rat
Compare ##p＜0.01 with the blank group; Compare * p＜0.05, * * p＜0.01 with the model of qi-asthenia group
By table 3 as seen:
1. model of qi-asthenia rat whole blood, plasma viscosity and packed cell volume all significantly raise, and compare P＜0.01,0.01,0.01 with the blank group.Extract is little, in, heavy dose of group all has the effect of the whole blood, plasma viscosity and the packed cell volume that reduce deficiency of vital energy rat in various degree, with the model of qi-asthenia group relatively, P＜0.05 or P＜0.01.Superfine powder is little, in, heavy dose of group all has the effect of the whole blood, plasma viscosity and the packed cell volume that reduce deficiency of vital energy rat in various degree, with the model of qi-asthenia group relatively, P＜0.05 or P＜0.01.
2. the heavy dose of group of extract and superfine powder all shows and the similar benefiting action of bolus of ten powerful tonics positive controls, and the effect of whole blood, plasma viscosity and the packed cell volume of reduction deficiency of vital energy rat is similar.
Experimental result shows that extract and superfine powder all have the benefiting action similar with bolus of ten powerful tonics, can improve the hemorheology indexs such as whole blood, plasma viscosity and packed cell volume of deficiency of vital energy rat, really has the effect of blood circulation promoting and blood stasis dispelling and tonification.
3 conclusion (of pressure testing)s
(1) pharmaceutical composition provided by the invention has the effect of shortening mice docking bleeding time and clotting time of mice, promptly has anastalsis.The heavy dose group dosage of extract and superfine powder is 4 times to small dose group (clinical treatment group), positive control GONGXUENING group dosage also is 4 times of clinical consumptions to this medicine description, therefore, hemostasis of mice and hemorrhage result of the test all show, no matter be extract or superfine powder, haemostatic effect all is the trend that is better than GONGXUENING.
(2) pharmaceutical composition provided by the invention has the benefiting action similar with bolus of ten powerful tonics to the model of qi-asthenia rat, can improve the hemorheology indexs such as whole blood, plasma viscosity and packed cell volume of deficiency of vital energy rat, really has the effect of blood circulation promoting and blood stasis dispelling and tonification.And 1/3 superfine powder dosage can play the effect that its full dose is extracted extractum.
(3) according to the dose-effect relationship of pharmacodynamics, this medicine clinical application amount is advisable with ≧ 15g crude drug/day/people.
Embodiment 14-16
The superfine powder that embodiment 2-4 prepared extraction extractum and embodiment 6-8 prepared superfine powder replace extraction extractum that embodiment 1 makes and embodiment 5 to make is respectively tested by the mode of embodiment 13, as a result unanimity.
Embodiment 17
Control and test for example
1. Lee *, the woman, 39 years old, people from Guangzhou surplus the irregular colporrhagia ten year, had little muscular tumor in the multiple cavity of uterus, Hb≤7g.Take our medicamental pulverata once a day, 15g/ time, decocting connects medicamental pulverata with clothes, and hemorrhage minimizing after three times is cured after seven times substantially.Come to go 10 times amount again, follow up a case by regular visits to title after 2 years and heal, hematochrome rises to more than the 13g.Body constitution and spirit all take on a new look, and claim hysteromyoma also to see and dwindle, and is very joyous.
2. Qiu *, people from Guizhou, the woman, 36 years old, more than near month of hemorrhage after drug abortion was not imitated all over controlling.Take our medicamental pulverata once a day, 15g/ time, decocting connects medicamental pulverata with clothes, promptly heals for three times.
3. Lee * *, people from Chongqing, the woman, 52 years old, massive hemorrhage again after the menopause was taken our medicamental pulverata once a day, and 15g/ time, decocting connects medicamental pulverata with clothes, once takes effect, and recurrence is not seen in three recoveries from illness so far.
4. old *, the Pekinese, the woman, 28 years old, endometriosis is arranged, violent dysmenorrhea, big through measuring, about ten days menstrual period, frequent January twice, misery.Take the more than end of blood once a day, 15g/ time, decocting connects medicamental pulverata with clothes, once reduces through amount, and three times warp is clean, advises and obeys twice again, consolidates curative effect, and when in the period, dysmenorrhea greatly alleviates after nearly one month, and normal through measuring, the no longer pain of passing through is expressed a thousand thanks.
5. Lee *, people from Jiangsu, woman, 26 years old, police officer, anteversion of uterus, dysmenorrhea, big through measuring, dim purple clot is arranged, in 4---5 days menstrual period, take our medicamental pulverata once a day, 15g/ time through the first five day, decocting connects medicamental pulverata with clothes, all three times, no longer dysmenorrhea from then in the period, seldom there is clot to discharge, normal menstrual period through amount, express a thousand thanks.
6. * recklessly, people from Shaanxi, the woman, 19 years old, sexual transaction person was accommodated education, and the contraception of clothes contraceptive is suffered from disintegration and is shown effect repeatedly, does not imitate all over controlling.Take our medicamental pulverata once a day, 15g/ time, add water and in the steamed rice cage, cook the back with the medicamental pulverata clothes, five recoveries from illness are not seen recurrence for a long time until separating religion release.
7. old *, people from Hunan, the woman, 18 years old, sexual transaction person was accommodated education, and the contraception of clothes contraceptive is suffered from disintegration and is shown effect repeatedly, does not imitate all over controlling.With the passing of time faint because of metrorrhagia before this, survey hematochrome 5.3g.Promptly use our medicamental pulverata behind the rescue recovery, once a day, 15g/ time, add water and in the steamed rice cage, cook the back with the medicamental pulverata clothes, five recoveries from illness, the check hematochrome reaches 11g behind the two weeks, does not see recurrence for a long time until separating to teach to discharge.
8. king *, the Cantonese, the woman, 29 years old, the school-days was that menstruation is uncomfortable, the dripping impermanence of menses, dysmenorrhea is violent, graduates from university after marriage menometrorrhagia impermanence, the long-term dull pain of lower abdomen, the time aggravation is arranged, infertile for many years, be uterine hypoplasia through looking into, seek medical advice in many ways, yuan invalid surplus in the of expensive 60,000.Take our medicamental pulverata every day twice, 15g/ time, decocting connects medicamental pulverata with clothes, and the clean back of every menstruation clothes 20 days serve on three months, and subjective symptoms disappears, and drug withdrawal was become pregnant unintentionally after five months, and is joyful.
The inventor only controls the over one hundred example of woman uterine bleeding with the present invention between year March in October, 2004 to 2005, still none example failure.
All quote in this application as a reference at all documents that the present invention mentions, just quoted as a reference separately as each piece document.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after having read above-mentioned teachings of the present invention, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Claims (10)
1. a pharmaceutical composition is characterized in that, it contains following component:
10-50 parts by weight Rhizoma Polygoni Paleachi;
10-40 parts by weight YIKOUXUE;
10-40 parts by weight RHIZOMA POLYGONI SUFFULTI;
5-30 parts by weight Radix Polygoni Ciliinerve;
And the pharmaceutically acceptable carrier of 50-1000 parts by weight;
Wherein the weight sum of Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI and Radix Polygoni Ciliinerve accounts for the 30-99% of composition total weight.
2. pharmaceutical composition as claimed in claim 1 is characterized in that it contains:
25-45 parts by weight Rhizoma Polygoni Paleachi;
15-35 parts by weight YIKOUXUE;
15-35 parts by weight RHIZOMA POLYGONI SUFFULTI;
10-20 parts by weight Radix Polygoni Ciliinerve.
3. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that, it is suppository, transdermal agent, powder, dissolved granule, pill, oral liquid, tablet or capsule.
4. a dietary supplement is characterized in that, it is made of following component:
10-50 parts by weight Rhizoma Polygoni Paleachi;
10-40 parts by weight YIKOUXUE;
10-40 parts by weight RHIZOMA POLYGONI SUFFULTI;
5-30 parts by weight Radix Polygoni Ciliinerve,
And the pharmaceutically acceptable carrier of surplus;
Wherein the weight sum of Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI and Radix Polygoni Ciliinerve accounts for the 30-99% of dietary supplement gross weight.。
5. described preparation of drug combination method of claim 1 is characterized in that it comprises step:
The medical material of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves or the extract of described medical material are mixed with the pharmaceutically acceptable carrier of 50-1000 parts by weight, obtain pharmaceutical composition.
6. preparation method as claimed in claim 5 is characterized in that, described extract prepares in order to the below method:
A mixes the medical material of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves;
B is crushed to 90% medical material granule can pass through 20-50 purpose screen cloth, the medical material that obtains pulverizing;
The medical material that c water or 10-90% ethanol extraction are pulverized obtains extract.
7. preparation method as claimed in claim 5 is characterized in that, described extract prepares in order to the below method:
A obtains extract with Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI, Radix Polygoni Ciliinerve water or 10-90% ethanol extraction respectively;
B mixes the medicinal substances extract of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves.
8. preparation method as claimed in claim 5 is characterized in that, described Rhizoma Polygoni Paleachi, YIKOUXUE, RHIZOMA POLYGONI SUFFULTI or Radix Polygoni Ciliinerve medical material are that mean diameter is smaller or equal to 50 microns powder more than or equal to 5 microns.
9. the application of pharmaceutical composition as claimed in claim 1 in the medicine of preparation treatment woman uterine bleeding, dysmenorrhea, constitutional or functional amenorrhea or hysteromyoma.
10. the purposes of a mixture, described mixture is made of 10-50 parts by weight Rhizoma Polygoni Paleachi, 10-40 parts by weight YIKOUXUE, 10-40 parts by weight RHIZOMA POLYGONI SUFFULTI and 5-30 parts by weight Radix Polygoni Ciliinerves, it is characterized in that described mixture is used to prepare the medicine of treatment woman uterine bleeding, dysmenorrhea, constitutional or functional amenorrhea or hysteromyoma.
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| 中药基本方辨证运用对崩漏治疗作用的研究. 潘天慧等.中医药临床杂志，第16卷第5期. 2004 |
| 中药基本方辨证运用对崩漏治疗作用的研究. 潘天慧等.中医药临床杂志，第16卷第5期. 2004 * |
| 子宫功能性出血的中药调治. 潘芝芬.河南中医，第23卷第11期. 2003 |
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Effective date of registration: 20091120 Address after: Guangdong science and Technology Park, Shantou University, Lu Rongsheng, zip code: 515063 Co-patentee after: Chen Zhongliang Patentee after: RUNBIO BIOTECH Co.,Ltd. Address before: Chongqing city Shapingba District Yubei Road, Shimen Street Village 142 1-1 zip code: 400036 Co-patentee before: Zheng Huiyi Patentee before: Chen Zhongliang |
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Address after: Room 116, Floor 1, Transportation Bureau Building, No. 95, Yingbin Avenue, Huacheng Street, Huadu District, Guangzhou, Guangdong, 510000 Patentee after: Guangdong Iconas Biomedical Technology Co.,Ltd. Patentee after: Chen Zhongliang Address before: Room 116, Floor 1, Transportation Bureau Building, No. 95, Yingbin Avenue, Huacheng Street, Huadu District, Guangzhou, Guangdong, 510000 Patentee before: Guangdong Iconas Biomedical Technology Co.,Ltd. Patentee before: Chen Zhongliang |
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Address after: Room 116, Floor 1, Transportation Bureau Building, No. 95, Yingbin Avenue, Huacheng Street, Huadu District, Guangzhou, Guangdong, 510000 Patentee after: Guangdong Iconas Biomedical Technology Co.,Ltd. Patentee after: Chen Zhongliang Address before: 515063 Lu Rongsheng Science Park, University of Guangdong, Shantou Patentee before: RUNBIO BIOTECH Co.,Ltd. Patentee before: Chen Zhongliang |