CN1439416A - Agent for protecting womb from profuse menstuation and its preparing method - Google Patents

Agent for protecting womb from profuse menstuation and its preparing method Download PDF

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CN1439416A
CN1439416A CN 03112031 CN03112031A CN1439416A CN 1439416 A CN1439416 A CN 1439416A CN 03112031 CN03112031 CN 03112031 CN 03112031 A CN03112031 A CN 03112031A CN 1439416 A CN1439416 A CN 1439416A
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radix
hemorrhage
palace
medicine
treatment
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CN1197607C (en
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于少华
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Tianjin Horus C&k Pharmaceutical Co ltd
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Abstract

A staltic Chinese medicine in the form of particles for treating functional metrorrhagia and the metrorrhegia cused by contraceptive ring is prepared from 10 Chinese-medicinal materials including oyster shell white peony root, biota tops, rehmannia root, etc through pre-processing, pulverizing, extracting in solvent, purifying, concentrating, drying and granulating. Its advantage is high curative effect.

Description

Preserve palace hemorrhage and preparation method thereof
(1) technical field
The present invention relates to a kind of medicine for the treatment of dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease, specifically is the luxuriant growth palace hemorrhage of feedstock production with the Chinese herbal medicine, the invention still further relates to the preparation method of this medicine.
(2) background technology
Menorrhagia, menostaxis are common gynecological disease, frequently-occurring disease.This type of disease incidence height, and often outbreak repeatedly of many patients, touching difficulty is that a class has a strong impact on the able-bodied disease of women more, brings inconvenience also for simultaneously patient's work, study and daily life.Part patient then can cause other a series of gynaecopathias because of the generation of above-mentioned disease.
According to national intrauterine device tackling key problem cooperative groups: with the major side effects behind the metal intrauterine contraceptive loop is excessive menstruation, and reached at the 400ml that blood volume is many is for putting preceding 8 times of ring, the incidence rate increase by 28% of secondary anemia.In single steel intrauterine device women's the side effect, menorrhagia accounts for 12.53~26.51% on 11 provinces and cities' sampling survey 106608 examples in the whole nation; Menostaxis accounts for 7.21~15.9%; Irregular bleeding accounts for 15.9%; Local inflammation accounts for 5.2~8.7%.Also have lower abdomen discomfort, leukorrhagia to wait until disease in addition.Promptly influence WomanHealth, increased the difficulty of implementation plan child-bearing policy again.
To the treatment of primary disease, following clinical difficult problem puzzlement is arranged at present:
1, uterotonic such as oxytocin, ergometrine can make uterus tetanic property contraction, and effect continues a few hours, and anastalsis is arranged.But can produce side effect such as temporary serious hypertension, water intoxication, unsuitable conventional the application.
2, the employing of operative therapy such as dilatation and curettage more should be prudent, and certain indication is arranged.The antibiotics itself that postoperative must add usefulness has outside the side effect, also can influence suckling.
3, the Chinese patent medicine of present less treatment primary disease, only several not fairly obvious as effects such as motherwort formulation, SHENGHUATANG plus-minus sides, can not satisfy the clinical treatment needs.
(3) summary of the invention
The objective of the invention is to address the above problem, a kind of comprehensive Chinese patent medicine that improves the advantage such as safe and effective, quality controllable of dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD symptom that has is provided, this medicine is carried out pharmacodynamic experiment, the inflammation that this medicine causes foreign body in the animal uterus has the obvious suppression effect, the acute inflammation in animals model is had the swelling of inhibition and transudation, and the infection that causes for ring on the clinical treatment provides foundation; This medicine has inhibitory action in various degree to animal at, isolated uterine smooth muscle, and can obviously resist the uterine smooth muscle that oxytocin causes and shrink strongly: this medicine can obviously shorten bleeding time and clotting time, and can significantly reduce the implicit amount of Fibrinogen, haemostatic effect is remarkable; This medicine is to blood plasma 6-Keto-PGF 1aHave obvious rising effect, improve the endogenous hormone level; This medicine also has significant analgesic activity.
Another object of the present invention provides the compounding method of this treatment dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD medicine.
For achieving the above object, the present invention has adopted following technical scheme:
A kind of luxuriant growth palace hemorrhage with treatment dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease, it is characterized in that: it is made by following raw material, various raw materials by weight ratio:
Concha Ostreae (forging) 4-15 part Radix Paeoniae Alba 2-10 part Cacumen Platycladi (parch to black) 2-10 part
Radix Rehmanniae 2-10 part Fructus Rosae Laevigatae 2-10 part Radix Bupleuri (processed with vinegar) 1-7 part
Radix Notoginseng 0.1-5 part Herba Agrimoniae 2-10 part Cortex Ailanthi 2-10 part
Folium Isatidis 2-10 part
Each raw material also can be by following weight portion proportioning
Concha Ostreae (forging) 3-10 part Radix Paeoniae Alba 3-8 part Cacumen Platycladi (parch to black) 3-8 part
Radix Rehmanniae 3-8 part Fructus Rosae Laevigatae 3-8 part Radix Bupleuri (processed with vinegar) 1-5 part
Radix Notoginseng 0.1-3 part Herba Agrimoniae 3-8 part Cortex Ailanthi 3-8 part
Folium Isatidis 3-8 part
Each raw material also can be by following weight portion proportioning
Concha Ostreae (forging) 6-7 part Radix Paeoniae Alba 3-4 part Cacumen Platycladi (parch to black) 4-5 part
Radix Rehmanniae 3-4 part Fructus Rosae Laevigatae 4-5 part Radix Bupleuri (processed with vinegar) 1-2 part
Radix Notoginseng 0.1-1 part Herba Agrimoniae 4-5 part Cortex Ailanthi 3-4 part
Folium Isatidis 3-4 part
Each raw material weight proportioning is
4.3 parts of Concha Ostreae (forging) 3.2 portions of Cacumen Platycladis of 6.4 portions of Radix Paeoniae Albas (parch to black)
1.5 parts of 4.2 parts of Radix Bupleuri (processed with vinegar) of 3.3 portions of Fructus Rosae Laevigatae of Radix Rehmanniae
3.3 parts of 4.4 parts of Cortex Ailanthis of 0.6 part of Herba Agrimoniae of Radix Notoginseng
3.5 parts of Folium Isatidiss
Said luxuriant growth palace hemorrhage can be a said dosage form on granule, liquid agent or other any pharmaceuticss.
A kind of preparation has the luxuriant growth palace hemorrhage method of treatment dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease, it is characterized in that:
(1) earlier Radix Notoginseng powder is broken into 100 ~ 120 order fine powders;
(2) with the Radix Paeoniae Alba, Radix Bupleuri Diluted Alcohol solution reflux, extract,, discard residue, it is standby that extracting solution reclaims the ethanol rear solution;
(3) Concha Ostreae, Cacumen Platycladi, Radix Rehmanniae, Fructus Rosae Laevigatae, Herba Agrimoniae, Cortex Ailanthi, Folium Isatidis are decocted with water secondary, 2 hours for the first time, 1 hour for the second time, discard residue, the decoction liquor sedimentation is spent the night, and extracts supernatant, merge extracting solution such as the above-mentioned Radix Paeoniae Alba, be condensed into the clear paste of relative density 1.32-1.37 (80 ℃), drying is ground into fine powder;
(4) evenly make granule with dry pressing or boiling granulation method in the back with Radix Notoginseng powder by described mixed.
At concentration of alcohol described in second step is 50%, and reflux, extract, twice is 2 hours for the first time, is 1 hour for the second time, merges extracted twice liquid, filter, and filtrate recycling ethanol, aqueous solution is standby.
In the 4th step, add an amount of dextrine powder, cane sugar powder, lactose powder, stevioside and mix homogeneously.
The solution of the present invention is based on motherland's medical science to dysfunctional uterine hemorrhage and pathogenetic understanding of hemorrhage due to placement of IUD disease and Therapeutic Principle, with reference to modern medicinal agents, pharmaceutical research achievement and form.
In motherland's medical science, to women's warp, produce, have comparatively maturation and scientific understanding, formed the theoretical system of complete uniqueness.Think CHONG meridian being the blood pool, appoint main uterus, through be bloodization, and blood comes from internal organs, annotate in towards times.Because congenital deficiency of kidney-QI, or work, excess of sexual intercourse, injure Liver and kidney, cause dashing appoint deficient, can not the astringency inducing menses, overflow and descending; Or the cloudy deficiency of dividing is arranged, heat lies prostrate the sea of blood; Or the hepatic and renal YIN deficiency, strongly fragrant and heat-transformation; Or keep fit indecorous, scorching in the asthenic fire, the impairment of YIN hematozemia; Or the course of disease with the passing of time, cloudy hinders with blood, and occur that Sthenia is transforming into asthenia or the resembling of simulataneous insufficiency and excessive, finally to become the card of deficiency of YIN heat in blood.Encircle in utero, the visitor takes the status of a sovereign by force, the disturbance menoxenia due to disturbance of CHONG meridian, and the debility of CHONG and REN meridians, menses lose and take the photograph, deficiency of YIN heat in blood in addition, hot forcing blood overflows, and causes menostaxis, menorrhagia.
At above-mentioned etiology and pathogenesis, this is a deficiency of kidney yin, is designated as in the asthenic fire and burns, and menses hold the mistake degree that overflows.Smelting is when Gu Chong hemostasis, nourishing YIN and clearing away heat.Both astringing for hemostasis to be to have filled in its stream, and clearing away heat and cooling blood is with Cheng Qiyuan again, and nourishing YIN and benefiting blood with multiple its old be principle of treatment.All medicines share, Gu Chong hemostasis, nourishing YIN and clearing away heat.Its receipts are taken the photograph and do not stagnate evil, astringency inducing and the gas that do not stagnate takes stopgap measures and do not forget to consolidate, heat clearing away is only used cold and cool.Kidney yin must be mended, irritability Shu Da, and menses must be transferred, and all diseases must be separated.
An important feature of medicine of the present invention is
1, presses the Chinese medical theory prescription, and in conjunction with the pure Chinese medicinal preparation that the modern scientific research achievement is made, have short treating period clinically, the characteristics of instant effect.At commonly encountered diseases, frequently-occurring disease, a sick medicine, outstanding Chinese medicine characteristic.
2, the prescription Chinese crude drug through science extract, purification, improve active constituent content, reduce dose, confirm evident in efficacyly through pharmacodynamics, toxicological experiment, the mice maximum tolerated dose is 280 times of clinical people's consumption; Long term toxicity test is not seen toxicity with 50 times of successive administrations of clinical people's consumption three months, does not see untoward reaction in treatment 300 routine menoxenia patients' clinical observation yet.Reached purpose safe, effective, taking convenience.
3, each step of pharmaceutical preparation of the present invention all has preparation laboratory data and the support of pharmacodynamics preference data, and has formulated the content of effective testing index, thereby guarantees product quality.
4, treat the medicine and the medical procedure of primary disease at present, can not satisfy the clinical treatment needs.
Medicine of the present invention provides a kind of new efficient medicine, increases a kind of powerful mean for clinical with the card medication.
Another important feature of medicine of the present invention is
1, contains a large amount of phenols components in the medicament, comprise agrimophol, paeonol etc., anastalsis is arranged, have in, isolated uterine smooth muscle excitation.
2, also contain a large amount of glycoside compositions in the medicament, comprise Quercitroside, peoniflorin, arasaponin, saikoside, indigo glycosides, iridoid glycoside and ginsenoside's class, paeoniflorin content 〉=20mg/ bag wherein, various pathogens, virus there is inhibitory action, uterine smooth muscle effect and tangible antiinflammatory action.
3, also contain a large amount of flavones ingredients in the medicament, total content reaches 1.2~2.0%, comprises amarolide, Quercetin, agrimonolide, kaempferide etc., and the isolated uterine excitation is arranged; Early pregnancy placental villi nurse tissue is cultivated, promoting sexual gland hormone one chorionic-gonadotropin hormone HCG secretory volume is increased.Also contain polysaccharide and several amino acids constituents.
The clinical use result of medicine of the present invention shows that following advantage is arranged:
1, to select natural plant for use be raw material in the present invention, and each component all meets Pharmacopoeia of the People's Republic of China regulation, press the comprehensive function treatment of Chinese medical theory prescription and treat dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease, no chemical substance.
2, medicine of the present invention through extract, purification, active constituent content height, dose are little, and the strict quality index is arranged, and reach safe and effective, and be quality controllable, the taking convenience requirement.Meet national medical rules.
3, medicine of the present invention provides a kind of new treatment means for treating dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease, replaces Western medicine and operative therapy, avoids its side effect.And its comprehensive function treatment dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease are replenished the blank of such disease treatment.
For showing the effect of Drug therapy dysfunctional uterine hemorrhage of the present invention and hemorrhage due to placement of IUD disease, medicine of the present invention is through the multicenter of 420 routine systems, contrast clinical observation at random, select according to " new Chinese medicine clinical research guideline " version in 1993 draft in, Western medicine diagnose, dialectical standard dysfunctional uterine hemorrhage and the hemorrhage due to placement of IUD disease patient research experiment made a definite diagnosis.
Differential diagnosis in tcm standard (deficiency of YIN heat in blood, syndrome of unconsolidation of Chong and Conception Channels)
Menorrhagia main symptom: menorrhagia.Inferior card: (1) deep red menses, matter is thick or little clot arranged; (2) soreness of the waist and knees; (3) dry mouth and throat; (4) hectic fever is vexed; (5) picture of the tongue: red tongue with lack of fluid, the few or no fur of tongue; (6) pulse condition: count accurately.Main symptom indispensability is wherein doublely seen three of time cards, and is promptly diagnosable.
Menostaxis main symptom: between 8-15 days menstrual period.Inferior card: the same month is through too much.Main symptom indispensability is wherein doublely seen three of time cards, and is promptly diagnosable.
The Western medicine diagnose standard
Menorrhagia: menstrual cycle is normal substantially, and amount is showed increased or surpass 100ml through amount more in the past, surpasses two above persons of menstrual cycle continuously.
Menostaxis: menstrual cycle and normal substantially through amount, the time of passing through surpassed more than 7 days, but was less than 15 days, surpassed two above persons of menstrual cycle continuously.
Instructions of taking: (1) observation group: medicine of the present invention, after coming, promptly begin to take, each 1 bag, every day 2 times, warm boiled water.Serve on for two weeks.(2) matched group: the safe granule in palace (Shanghai No.3 Traditional Chinese Medicine Pharmaceutical Factory's production) promptly begins to take after coming, and each 1 bag, every day 2 times, warm boiled water.Serve on for two weeks.
The course of treatment: 1 month is a course of treatment, observes two courses of treatment.Follow up a case by regular visits to three menstrual cycle after the drug withdrawal.
Result of the test
(1), efficacy assessment standard and foundation: the efficacy assessment standard in the clinical research guideline of menoxenia " new Chinese medicine treatment " issued with reference to Ministry of Health of the People's Republic of China and drafting.
The symptom integral method
Menstrual blood volume: normal 0 minute; Amount was many more in the past, but was less than 100ml 2 minutes; The 100-150ml4 branch; More than 150ml 6 minutes.
Persistent period: normal 0 minute; 8 days-10 days 2 minutes; 11 days-13 days 4 minutes; 14 days-15 days 6 minutes.
The moon stands color: normal 0 minute; Dark red 1 minute; Purple 2 minutes of color; Purple dim or dark purple 3 minutes.
Menstruation quality: normal 0 minute; Thick partially, but do not have clot 1 minute; Thick, a small amount of little clot 2 minutes; Thickness, volume clot 3 minutes;
Waist sacrum symptom: do not have 0 fen; The waist sacrum is aching and limp, accidental 1 minute; The waist sacrum is aching and limp, shows effect repeatedly 2 fens; The waist sacrum is aching and limp, continues outbreak, is difficult for alleviating 3 fens.
Dry mouth and throat: do not have 0 fen; Idol was felt 1 fen; Obviously, still can stand 2 fens; Often outbreak was difficult to stand 3 fens.
Hectic fever: do not have 0 fen; Heating has regularly, the fever of the body of laying one's hand on not very, the persistent period is very short 1 minute; Heating has regularly, the scorching fever of laying one's hand on, long 2 minutes persistent period; Heating has regularly, the high fever like the burning coal over the body of laying one's hand on, and the persistent period is very long 3 minutes.
Vexed: as not have 0 fen; Idol has 1 fen; Often 2 minutes; 3 minutes all day.
Tongue fur: normal 0 minute; Body of the tongue is red partially, few Tianjin of yellow and thin fur 1 minute; The few tongue of red tongue 2 minutes; Red and uncoated tongue 3 minutes.
Efficacy assessment standard
Recovery from illness: treatment back menstruation recovers normal through amount, cycle, menstrual period, other transference cure, and 3 menstrual cycle of drug withdrawal do not recur, and integrated value is 3 minutes.
Produce effects: treatment back menstrual cycle returned to 28 ± 7 days, menorrhagia person has reduced 1/3 or be less than 100ml before amount is than treatment, return in 7 days other transference cure or alleviate menstrual period, 3 menstrual cycle of drug withdrawal do not recur, and integrated value treatment back reduces more than 2/3 than treatment is preceding.
Effectively: treat back menstrual cycle, improvement before amount, ratio treatment in menstrual period, other symptom also than alleviating before the treatment, reduces more than 1/3 than treatment is preceding after the integrated value treatment.
Invalid: treatment back menstrual cycle, do not have through amount, menstrual period and to improve or increase the weight of, integrated value treatment back than treatment before no change or than reduction before the treatment less than 1/3.
Efficacy analysis: the detailed results of this clinical observation, see the following table general curative effect for details
Comparison (%) group n recovery from illness (band) 60 28 (46.67) 17 (28.33) 10 (16.67) 5 (8.33) 2.0526<0.05 control groups, 30 6 (20.00) 13 (43.33) 7 (23.34) 4 (13.33) observation groups of produce effects enabledisable u p observation group (not band) 90 33 (36.67) 26 (28.89) 25 (27.78) 6 (6.66) 1.9657<0.05 control groups 30 6 (20.00) 8 (26.67) 12 (40.00) 4 (13.33) of two groups of menostaxis person's general curative effects
As can be seen from the above table: medicine band group cure rate of the present invention reaches 46.67%, obvious effective rate 28.33%, effective percentage 16.67%, inefficiency 8.33%, total obvious effective rate 75.00%, total effective rate 91.67%.The matched group cure rate reaches 20.00%, obvious effective rate 43.33%, effective percentage 23.34%, inefficiency 13.33%, total obvious effective rate 63.33%, total effective rate 86.67%.And two groups of general curative effects are analyzed relatively u=2.0526, p<0.05 through Ridit.The general curative effect of description medicine of the present invention is excellent than matched group.Medicine anovulatory dysfunctional uterine hemorrhage group cure rate of the present invention reaches 36.67%, obvious effective rate 28.89%, effective percentage 27.78%, inefficiency 6.66%, total obvious effective rate 65.56%, total effective rate 93.33%.The matched group cure rate reaches 20.00%, obvious effective rate 26.67%, effective percentage 40.00%, inefficiency 13.33%, total obvious effective rate 46.67%, total effective rate 86.67%.And two groups of general curative effects are analyzed relatively u=1.9657, p<0.05 through Ridit.The general curative effect of description medicine of the present invention is excellent than matched group.
Two groups menstrual period too much person's general curative effect comparison (%) group n recovery from illness (band) 90 33 (36.67) 22 (24.44) 27 (30.00) 8 (8.89) 2.3640<0.05 control groups, 30 4 (13.33) 8 (26.67) 13 (43.33) 5 (16.67) observation groups of produce effects enabledisable u p observation group (not band) 60 24 (40.00) 17 (28.33) 13 (21.67) 6 (10.00) 1.0629<0.05 control groups 30 9 (30.00) 8 (26.67) 9 (30.00) 4 (13.33)
As can be seen from the above table: medicine band group cure rate of the present invention reaches 36.67%, obvious effective rate 24.44%, effective percentage 30.00%, inefficiency 8.89%, total obvious effective rate 61.11%, total effective rate 91.11%.The matched group cure rate reaches 13.33%, obvious effective rate 26.67%, effective percentage 43.33%, inefficiency 16.67%, total obvious effective rate 40.00%, total effective rate 83.33%.And two groups of general curative effects are analyzed relatively u=2.3640, p<0.05 through Ridit.The general curative effect of description medicine of the present invention is excellent than matched group.Medicine anovulatory dysfunctional uterine hemorrhage group cure rate of the present invention reaches 40.00%, obvious effective rate 28.33%, effective percentage 21.67%, inefficiency 10.00%, total obvious effective rate 68.33%, total effective rate 90.00%.The matched group cure rate reaches 30.00%, obvious effective rate 26.67%, effective percentage 30.00%, inefficiency 13.33%, total obvious effective rate 56.67%, total effective rate 86.67%.And two groups of general curative effects are analyzed relatively u=1.0629, p<0.05 through Ridit.The general curative effect of description medicine of the present invention is excellent than matched group.
The curative effect of two groups of menostaxis person state of an illness integrations compares (%) before and after the treatment
(the treatment back of x ± the s) (observation group's (band) 60 14.95 ± 3.92 3.07 ± 4.31 of x ± s) before the group n treatment △ △ ※ ※Matched group 30 14.47 ± 4.49 5.63 ± 4.66 △ △Observation group's (anovulatory dysfunctional uterine hemorrhage) 90 12.94 ± 3.94 3.07 ± 3.89 △ △ ※ ※Matched group 30 13.03 ± 4.63 5.47 ± 4.46 △ △
Annotate: with relatively use before the treatment △ △Expression P<0.01; With relatively use after the treatment of control group ※ ※Expression P<0.01.
As can be seen from the above table: before and after two groups of treatments the curative effect of menostaxis person state of an illness integration is more all had utmost point significant difference, P<0.01; Medicine of the present invention is being better than the safe groups of grains in palace, P<0.01 again aspect the curative effect of menostaxis.
The curative effect of two groups of menorrhagia person's state of an illness integrations compares (%) before and after the treatment
(the treatment back of x ± the s) (observation group's (band) 90 13.14 ± 4.04 3.51 ± 3.98 of x ± s) before the group n treatment △ △ ※Matched group 30 12.77 ± 3.10 5.23 ± 2.76 △ △Observation group's (not band) 60 13.40 ± 3.79 3.53 ± 4.26 △ △Matched group 30 13.77 ± 3.87 4.30 ± 4.49 △ △
Annotate: with relatively use before the treatment △ △Expression P<0.01; With relatively use after the treatment of control group Expression P<0.05.
As can be seen from the above table: before and after two groups of treatments the curative effect of menorrhagia person's state of an illness integration is more all had utmost point significant difference, P<0.01; Be better than the safe groups of grains in palace aspect the menorrheal curative effect that medicine of the present invention causes at band, P<0.05.But there was no significant difference aspect two groups of menorrheal curative effects that cause at anovulatory dysfunctional uterine hemorrhage, P>0.05.
The curative effect that symptom and sign changes before and after the treatment relatively
The curative effect of two groups of treatment front and back menorrhagia (band) symptom and sign variations relatively
Before the treatment After the treatment In the group Between group
Sign n
(example) ++++++-++++++-u p u p menstrual blood volume observation group 90 29 56 5019 43 37 10.2419<0.01 1.2408>0.05
30 6 21 3022 18 8 5.0982<0.01 persistent period of matched group observation group 90 05 30 55 007 83 3.6650<0.01 0.3652>0.05
Matched group 30 008 22 001 29 1.5653>0.05 month is through color observation group 90 6 26 55 004 33 53 7.6886<0.01 1.8562>0.05
Matched group 30 0 11 17 200 20 10 3.4286<0.01 month is through quality observation group 90 5 32 51 204 29 57 8.3757<0.01 0.8398>0.05
Matched group 30 0 12 15 3009 21 4.8300<0.01 waist sacrum observation of symptoms group 90 4 28 53 503 28 59 8.0458<0.01 2.1240<0.05
Matched group 30 2 21 6102 16 12 5.1429<0.01 dry mouth and throat observation group 90 1 15 37 37 01 10 79 5.6061<0.01 0.1126>0.05
Matched group 30 06 14 10 007 23 3.2199<0.01 hectic fever observation group 90 03 31 56 015 84 3.5918<0.01 0.2769>0.05
Matched group 30 019 20 001 29 2.0199<0.01 vexed observation group 90 3 21 48 18 03 16 71 7.1995<0.01 1.7071>0.05
Matched group 30 09 15 600 13 17 3.3317<0.01 picture of the tongue observation group 90 0 18 70 202 30 58 7.8033<0.01 1.7284>0.05
Matched group 30 0 13 13 401 16 13 3.4659<0.01
As can be seen from the above table: menorrhagia (band) symptom and sign all has extremely significant improvement effect before and after the Drug therapy of the present invention, p<0.01 or p<0.05, and on waist sacrum symptom, be excellent than matched group, p<0.05.
The curative effect of two groups of treatment front and back menostaxis (anovulatory dysfunctional uterine hemorrhage) symptom and sign variations relatively
Before the treatment After the treatment In the group Between group
Sign n
(example) ++++++-++++++-u p u p menstrual blood volume observation group 90 08 36 46 01 17 72 3.5000<0.01 1.1015>0.05
30 067 17 002 28 2.5491<0.01 persistent period of matched group observation group 90 22 53 15 005 34 51 10.292<0.01 0.3652>0.05
Matched group 30 66 18 016 12 11 2.8175>0.05 month is through color observation group 90 5 28 47 10 04 29 57 7.1995<0.01 3.4476<0.01
Matched group 30 0 19 11 007 15 8 3.3392<0.01 month is through quality observation group 90 5 30 48 703 23 64 8.3284<0.01 3.3959<0.01
Matched group 30 0 22 8006 14 10 4.1740<0.01 waist sacrum observation of symptoms group 90 5 23 56 606 28 56 7.1406<0.01 0.5782>0.05
Matched group 30 2 16 11 101 13 16 5.0312<0.01 dry mouth and throat observation group 90 1 15 53 21 024 84 8.0759<0.01 0.8277>0.05
Matched group 30 12 17 10 023 25 3.1827<0.01 hectic fever observation group 90 05 39 46 015 84 4.8857<0.01 0.5356>0.05
Matched group 30 02 10 18 004 26 1.8485>0.05 vexed observation group 90 2 20 42 26 02 13 75 6.6214<0.01 0.8185>0.05
Matched group 30 02 19 9017 22 2.8696<0.01 picture of the tongue observation group 90 0 18 68 402 24 64 8.1706<0.01 2.4952<0.05
Matched group 30 0 11 19 004 13 13 3.4063<0.01
As can be seen from the above table: menostaxis (anovulatory dysfunctional uterine hemorrhage) symptom and sign all has extremely significant improvement effect before and after the Drug therapy of the present invention, p<0.01, and on persistent period, menstruation color, menstruation quality, picture of the tongue, be excellent than matched group, p<0.01 or p<0.05.
Model case: thank so-and-so, woman, 27 years old, the work of Overseas Chinese Hotel, Changchun, No. 23, case numbering.
This patient goes to a doctor because of the menstrual blood volume showed increased half a year, patient's readme menstruation in puerperal is gone over the past half year again, and the more preceding showed increased of menstruation is at every turn with sanitary towel's 3 bags (30), pass through 8 days to 9 days beginnings only at every turn, deep red menses, thick menses, but do not have clot, the companion sees soreness of the waist and knees, the time have vexed, the few Tianjin of red tongue, tongue fur BOHUANG, thready and rolling pulse.Be menstrual cycle first day when examining, got rid of organic disease, blood, routine urinalysis through B ultrasonic and gynecologial examination, electrocardiogram, liver, renal function procuratorial work are normal, FIB3.4g/L, doctor trained in Western medicine examine for: dysfunctional uterine bleeding (the ovulation type is arranged), the traditional Chinese medical science are examined and are menorrhagia (deficiency of YIN blood-heat type).Medicine of the present invention is given in throwing, one time 1 bag, 2 times on the one, oral, be connected with the back of taking medicine in two weeks to next menstrual onset, patient's readme is through the more preceding minimizing of amount, but still is many more in the past, with sanitary towel's 2 bags (20), 8 old name for the Arabian countries in the Middle Easts of passing through are clean, the menstruation quality as before, but the more preceding improvement of soreness of the waist and knees, surplus disease such as preceding.Continue clothes two weeks of medicine-feeding again, all transfer to normally through amount, phase, color, matter, surplus disease disappears.Check blood, routine urinalysis after the drug withdrawal, electrocardiogram, liver, renal function are all normal, and FIB3.3g/L follows up a case by regular visits to three menstrual cycle, does not see recurrence, clinical cure.Do not find untoward reaction at viewing duration.
The clinical efficacy of medicine of the present invention
Test statistics shows: the clinical efficacy of Drug therapy dysfunctional uterine hemorrhage of the present invention and hemorrhage due to placement of IUD disease patient 300 examples is satisfied, its menostaxis band group cure rate reaches 46.67%, obvious effective rate reaches 28.33%, effective percentage reaches 16.67%, inefficiency is 8.33%, total obvious effective rate reaches 75.00%, and total effective rate reaches 91.67%; The matched group cure rate reaches 20.00%, and obvious effective rate reaches 43.33%, and effective percentage reaches 23.34%, and inefficiency is 13.33%, and total obvious effective rate reaches 63.33%, and total effective rate reaches 86.67%, but two groups of general curative effects are analyzed relatively p<0.05 through Ridit.The general curative effect that medicine of the present invention is described is better than matched group.Medicine menostaxis anovulatory dysfunctional uterine hemorrhage group cure rate of the present invention reaches 36.67%, and obvious effective rate reaches 28.89%, and effective percentage reaches 27.78%, and inefficiency is 6.66%, and total obvious effective rate reaches 65.56%, and total effective rate reaches 93.33%; The matched group cure rate reaches 20.00%, and obvious effective rate reaches 26.67%, and effective percentage reaches 40.00%, and inefficiency is 13.33%, and total obvious effective rate reaches 46.67%, and total effective rate reaches 86.67%, two group of general curative effect and analyzes relatively p<0.05 through Ridit.The general curative effect that medicine of the present invention is described is better than matched group.Medicine menorrhagia band group cure rate of the present invention reaches 36.67%, and obvious effective rate reaches 24.44%, and effective percentage reaches 30.00%, and inefficiency is 8.89%, and total obvious effective rate reaches 61.11%, and total effective rate reaches 91.11%; The matched group cure rate reaches 13.33%, and obvious effective rate reaches 26.67%, and effective percentage reaches 43.33%, and inefficiency is 16.67%, and total obvious effective rate reaches 40.00%, and total effective rate reaches 83.33%, two group of general curative effect and analyzes relatively p<0.05 through Ridit.The general curative effect that medicine of the present invention is described is better than matched group.Medicine menorrhagia anovulatory dysfunctional uterine hemorrhage group cure rate of the present invention reaches 40.00%, and obvious effective rate reaches 28.33%, and effective percentage reaches 21.67%, and inefficiency is 10.00%, and total obvious effective rate reaches 68.33%, and total effective rate reaches 90.00%; The matched group cure rate reaches 30.00%, and obvious effective rate reaches 26.67%, and effective percentage reaches 30.00%, and inefficiency is 13.33%, and total obvious effective rate reaches 56.67%, and total effective rate reaches 86.67%, two group of general curative effect and analyzes relatively p>0.05 through Ridit.The general curative effect that medicine of the present invention is described is consistent with matched group.It is to menostaxis, menorrheal state of an illness integration, symptom and sign all improves significantly, p<0.01 or p<0.05, and menstruation persistent period of menstruation persistent period, picture of the tongue and the menostaxis anovulatory dysfunctional uterine hemorrhage group of the state of an illness integration of menostaxis band group and menostaxis band group, menstruation color, menstruation quality, picture of the tongue etc. to aspect all be better than matched group, p<0.01 or p<0.05.
The above results explanation: medicine of the present invention is the Chinese medicine for the treatment of a kind of determined curative effect of the dysfunctional uterine hemorrhage of deficiency of YIN blood-heat type menorrhagia and menostaxis symptom and hemorrhage due to placement of IUD patient clinically, is worthy to be popularized, uses.
(4) specific embodiment
The invention will be further described below in conjunction with embodiment.
Embodiment one:
A kind of luxuriant growth palace hemorrhage with treatment dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease, it is characterized in that: it is made by following raw material, various raw materials by weight ratio:
Concha Ostreae (forging) 4-15 part Radix Paeoniae Alba 2-10 part Cacumen Platycladi (parch to black) 2-10 part
Radix Rehmanniae 2-10 part Fructus Rosae Laevigatae 2-10 part Radix Bupleuri (processed with vinegar) 1-7 part
Radix Notoginseng 0.1-5 part Herba Agrimoniae 2-10 part Cortex Ailanthi 2-10 part
Folium Isatidis 2-10 part
Embodiment two:
Each raw material by weight ratio
Concha Ostreae (forging) 3-10 part Radix Paeoniae Alba 3-8 part Cacumen Platycladi (parch to black) 3-8 part
Radix Rehmanniae 3-8 part Fructus Rosae Laevigatae 3-8 part Radix Bupleuri (processed with vinegar) 1-5 part
Radix Notoginseng 0.1-3 part Herba Agrimoniae 3-8 part Cortex Ailanthi 3-8 part
Folium Isatidis 3-8 part
Embodiment three:
Wherein each raw material weight proportioning is
Concha Ostreae (forging) 6-7 part Radix Paeoniae Alba 3-4 part Cacumen Platycladi (parch to black) 4-5 part
Radix Rehmanniae 3-4 part Fructus Rosae Laevigatae 4-5 part Radix Bupleuri (processed with vinegar) 1-2 part
Radix Notoginseng 0.1-1 part Herba Agrimoniae 4-5 part Cortex Ailanthi 3-4 part
Folium Isatidis 3-4 part
Embodiment four:
Wherein each raw material weight proportioning is
4.3 parts of Concha Ostreae (forging) 3.2 portions of Cacumen Platycladis of 6.4 portions of Radix Paeoniae Albas (parch to black)
1.5 parts of 4.2 parts of Radix Bupleuri (processed with vinegar) of 3.3 portions of Fructus Rosae Laevigatae of Radix Rehmanniae
3.3 parts of 4.4 parts of Cortex Ailanthis of 0.6 part of Herba Agrimoniae of Radix Notoginseng
Folium Isatidis 3-4 part
Embodiment five:
Wherein each raw material weight proportioning is
4.3 parts of Concha Ostreae (forging) 3.2 portions of Cacumen Platycladis of 6.4 portions of Radix Paeoniae Albas (parch to black)
1.5 parts of 4.2 parts of Radix Bupleuri (processed with vinegar) of 3.3 portions of Fructus Rosae Laevigatae of Radix Rehmanniae
3.3 parts of 4.4 parts of Cortex Ailanthis of 0.6 part of Herba Agrimoniae of Radix Notoginseng
3.5 parts of Folium Isatidiss
Use for convenient, the present invention can be a said dosage form on granule, liquid agent or other any pharmaceuticss, is granule in the present invention.
Preparation method of the present invention is:
(1) earlier Radix Notoginseng powder is broken into 100 ~ 120 order fine powders;
(2) with the Radix Paeoniae Alba, Radix Bupleuri Diluted Alcohol solution reflux, extract,, discard residue, it is standby that extracting solution reclaims the ethanol rear solution;
(3) Concha Ostreae, Cacumen Platycladi, Radix Rehmanniae, Fructus Rosae Laevigatae, Herba Agrimoniae, Cortex Ailanthi, Folium Isatidis are decocted with water secondary, 2 hours for the first time, 1 hour for the second time, discard residue, the decoction liquor sedimentation is spent the night, and extracts supernatant, merge extracting solution such as the above-mentioned Radix Paeoniae Alba, be condensed into the clear paste of relative density 1.32-1.37 (80 ℃), drying is ground into fine powder;
(4) evenly make granule with dry pressing or boiling granulation method in the back with Radix Notoginseng powder by described mixed.
With 50% alcohol reflux secondary, 2 hours for the first time, 1 hour for the second time, the merging secondary raffinate filtered in second step, filtrate recycling ethanol, and aqueous solution is standby; All the other Concha Ostreaes, Cacumen Platycladi, Radix Rehmanniae, Fructus Rosae Laevigatae, Herba Agrimoniae, Cortex Ailanthi, Folium Isatidis decoct with water secondary, and 2 hours for the first time, 1 hour for the second time, merge decoction liquor, filter the filtrate standing over night, supernatant is extracted in sedimentation, merges backflow such as the above-mentioned Radix Paeoniae Alba, be condensed into thick paste, drying under reduced pressure, dried cream powder is broken into fine powder, with Radix Notoginseng powder and an amount of dextrine powder, cane sugar powder, lactose powder, stevioside mixing, granulate, drying, promptly.

Claims (8)

1, a kind of luxuriant growth palace hemorrhage with treatment dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease, it is characterized in that: it is made by following raw material, various raw materials by weight ratio:
Concha Ostreae (forging) 4-15 part Radix Paeoniae Alba 2-10 part Cacumen Platycladi (parch to black) 2-10 part
Radix Rehmanniae 2-10 part Fructus Rosae Laevigatae 2-10 part Radix Bupleuri (processed with vinegar) 1-7 part
Radix Notoginseng 0.1-5 part Herba Agrimoniae 2-10 part Cortex Ailanthi 2-10 part
Folium Isatidis 2-10 part
2, luxuriant growth according to claim 1 palace hemorrhage, it is characterized in that: each raw material is optimum ratio by weight
Concha Ostreae (forging) 3-10 part Radix Paeoniae Alba 3-8 part Cacumen Platycladi (parch to black) 3-8 part
Radix Rehmanniae 3-8 part Fructus Rosae Laevigatae 3-8 part Radix Bupleuri (processed with vinegar) 1-5 part
Radix Notoginseng 0.1-3 part Herba Agrimoniae 3-8 part Cortex Ailanthi 3-8 part
Folium Isatidis 3-8 part
3, luxuriant growth palace hemostasis granules agent according to claim 1, it is characterized in that: wherein the further preferred weight proportioning of each raw material is
Concha Ostreae (forging) 6-7 part Radix Paeoniae Alba 3-4 part Cacumen Platycladi (parch to black) 4-5 part
Radix Rehmanniae 3-4 part Fructus Rosae Laevigatae 4-5 part Radix Bupleuri (processed with vinegar) 1-2 part
Radix Notoginseng 0.1-1 part Herba Agrimoniae 4-5 part Cortex Ailanthi 3-4 part
Folium Isatidis 3-4 part
4, luxuriant growth according to claim 1 palace hemorrhage, it is characterized in that: wherein the best by weight proportioning of each raw material is
4.3 parts of Concha Ostreae (forging) 3.2 portions of Cacumen Platycladis of 6.4 portions of Radix Paeoniae Albas (parch to black)
1.5 parts of 4.2 parts of Radix Bupleuri (processed with vinegar) of 3.3 portions of Fructus Rosae Laevigatae of Radix Rehmanniae
3.3 parts of 4.4 parts of Cortex Ailanthis of 0.6 part of Herba Agrimoniae of Radix Notoginseng
3.5 parts of Folium Isatidiss
5, according to claim 1,2,3 or 4 described luxuriant growth palace hemorrhages, it is characterized in that: said luxuriant growth palace hemorrhage can be a said dosage form on granule, liquid agent or other any pharmaceuticss.
6, a kind of preparation method with luxuriant growth palace hemorrhage of treatment dysfunctional uterine hemorrhage and hemorrhage due to placement of IUD disease is characterized in that:
(1) earlier Radix Notoginseng powder is broken into 100 ~ 120 order fine powders;
(2) with the Radix Paeoniae Alba, Radix Bupleuri Diluted Alcohol solution reflux, extract,, discard residue, it is standby that extracting solution reclaims the ethanol rear solution;
(3) Concha Ostreae, Cacumen Platycladi, Radix Rehmanniae, Fructus Rosae Laevigatae, Herba Agrimoniae, Cortex Ailanthi, Folium Isatidis are decocted with water secondary, 2 hours for the first time, 1 hour for the second time, discard residue, the decoction liquor sedimentation is spent the night, and extracts supernatant, merge extracting solution such as the above-mentioned Radix Paeoniae Alba, be condensed into the clear paste of relative density 1.32-1.37 (80 ℃), drying is ground into fine powder;
(4) evenly make granule with dry pressing or boiling granulation method in the back with Radix Notoginseng powder by described mixed.
7, preparation method according to claim 6 is characterized in that: at concentration of alcohol described in second step is 50%, and reflux, extract, twice is 2 hours for the first time, is 1 hour for the second time, merges extracted twice liquid, filter, and filtrate recycling ethanol, aqueous solution is standby.
8, preparation method according to claim 6 is characterized in that: in the 4th step, add an amount of dextrine powder, cane sugar powder, lactose powder, stevioside and mix homogeneously.
CN 03112031 2003-03-24 2003-03-24 Agent for protecting womb from profuse menstuation and its preparing method Expired - Lifetime CN1197607C (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101856431A (en) * 2010-06-02 2010-10-13 南京中医药大学 Medicament for treating liver-kidney yin deficiency type anovulatory dysfunctional uterine bleeding, and preparation method and application thereof
CN104587219A (en) * 2015-02-15 2015-05-06 山东省文登整骨医院 Traditional Chinese medicine for treating functional uterine bleeding
CN104825495A (en) * 2015-04-19 2015-08-12 青岛大学 Oyster extract and application thereof in medicaments for promoting postpartum uterine contraction

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101856431A (en) * 2010-06-02 2010-10-13 南京中医药大学 Medicament for treating liver-kidney yin deficiency type anovulatory dysfunctional uterine bleeding, and preparation method and application thereof
CN101856431B (en) * 2010-06-02 2011-08-31 南京中医药大学 Medicament for treating liver-kidney yin deficiency type anovulatory dysfunctional uterine bleeding, and preparation method and application thereof
CN104587219A (en) * 2015-02-15 2015-05-06 山东省文登整骨医院 Traditional Chinese medicine for treating functional uterine bleeding
CN104825495A (en) * 2015-04-19 2015-08-12 青岛大学 Oyster extract and application thereof in medicaments for promoting postpartum uterine contraction

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