CN1785307A - Chinese medicine for treating mammary gland cystoma, mammitis and preparation method of its film coating - Google Patents
Chinese medicine for treating mammary gland cystoma, mammitis and preparation method of its film coating Download PDFInfo
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Abstract
A Chinese medicine in the form of coated tablet for treating cystic hyperplasia of breast and mastadenitis is prepared from microcrystalline cellulose, alcohol, CaSO4 and 15 Chinese-medicinal materials including antler, dandelion herb, notoginseng, red peony root, etc. Its preparing process is also disclosed.
Description
Affiliated technical field
The present invention relates to a kind of Chinese medicine and preparation method thereof, relate in particular to a kind of preparation method that is used for the treatment of the Chinese medicine and the Film coated tablets thereof of cystic hyperplasia of breast and mastitis.
Background technology
Cystic hyperplasia of breast is common clinical, frequently-occurring disease, especially occupy the majority with women patient, have female patient more than 25% that in various degree mastopathy is arranged according to statistics approximately, in mastopathy, cystic hyperplasia of breast and mammitis account for more than 79%, age of onset is more common in the 25-50 age group in year, and the course of disease of morbidity is different in size, short then several months, long then surplus in the of 10 year, show as breast periodically pain and mammary gland tumor, had a strong impact on women's physical and mental health, influence work and life.It is several that the method for treatment cystic hyperplasia of breast and mastitis is divided into hormone therapy, operation and Chinese medicine for oral administration treatment at present; Though operative treatment definite effect wherein, it costs an arm and a leg, the operation back influence the patient from now on life and do not accepted by extensive patients; Hormonal medicaments treatment for oral administration, side effect is bigger, can not eradicate source of disease, easily recurrence, and expense costliness; The treatment of Chinese medicine class endo-medicine is because side effect is little, taking convenience, treating both the principal and secondary aspects of a disease, expense is low and accepted by extensive patients, but some curative pharmic functions are single at present, do not see the effective Chinese medicine that can have treatment cystic hyperplasia of breast and mastitis simultaneously, and the Chinese medicine for the treatment of cystic hyperplasia of breast and mastitis at present is to improving mastalgia, touch a tender spot and dwindle aspects such as lump scope and onset time and be still waiting further reinforcement, therefore research and development are at the characteristics of incidence of mastopathy, can fundamentally solve source of disease, be difficult for recurrence, the Chinese medicine medicine that expense is low is the technical problem that present those skilled in the art are badly in need of solving.
Summary of the invention
The present invention is exactly a kind of Chinese medicine for the treatment of cystic hyperplasia of breast and mastitis that provides in order to solve the problems of the technologies described above, it has the effect for the treatment of cystic hyperplasia of breast and mastitis simultaneously, remarkable for effect on scope of dwindling lump in breast and the alleviating pain, cost is low, therapeutic effect is good, and is rapid-action.
Another technical problem to be solved by this invention provides a kind of preparation method for the treatment of the Chinese medicine Film coated tablets of cystic hyperplasia of breast and mastitis.
Be achieved in that a kind of Chinese medicine for the treatment of cystic hyperplasia of breast and mastitis in order to solve the problems of the technologies described above the present invention, it is to count ratio by following raw materials in parts by weight to be prepared from: Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi; Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=200-400: 100-300: 600-950: 40-120: 100-300: 100-300: 25-95: 260-480: 80-180: 90-240: 100-300: 180-380: 100-300: 40-120: 80-180: 30-130: 1000-3000: 20-60.
The Chinese medicine of described treatment cystic hyperplasia of breast and mastitis, it is to count ratio by following raw materials in parts by weight to be prepared from: Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=260-340: 160-220: 700-860: 60-120: 160-220: 160-220: 40-80: 330-430: 100-140: 140-180: 160-220: 240-310: 180-230: 60-100: 90-160: 50-90: 1500-2100: 35-45.
The Chinese medicine of described treatment cystic hyperplasia of breast and mastitis, it is to count ratio by following raw materials in parts by weight to be prepared from: Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=300: 200: 780: 80: 200: 200: 60: 390: 120: 160: 200: 280: 200: 80: 120: 67.4: 2022: 40.
The preparation method of a kind of described treatment cystic hyperplasia of breast and mastitis Chinese medicine Film coated tablets, it comprises following processing step:
Get Radix Scrophulariae, Radix Notoginseng, Cornu Cervi mixing back pulverizing, it is standby to get fine powder;
Get Herba Taraxaci, Thallus Laminariae (Thallus Eckloniae), Radix Trichosanthis, Caulis Spatholobi, Radix Paeoniae Rubra, Sargassum, Radix Rhapontici, the Radix Aucklandiae, Cortex Moutan, Spica Prunellae, Fructus Forsythiae, Flos Carthami and decoct with water collecting decoction, filter, being concentrated into and measuring relative density with gravimeter 50-60 ℃ the time is the concentrated solution of 1.15-1.17, it is the extractum of 1.36-1.40 that concentrated solution is evaporated to the relative density of measuring 50-60 ℃ the time, extractum is mixed the back under 50-60 ℃ of temperature dry 5-15 hour with above-mentioned fine powder, rewinding then, through pulverize, sieve medicated powder, with medicated powder and CaSO
4Mix with microcrystalline Cellulose, the alcoholic solution wetting agent that adds the 75-80% that is made by 95% ethanol and water planting then stirs, sieve wet granular, wet granular is 50-60 ℃ in temperature to be descended dry 30-60 minute, granulate must be done granule, mix the back tabletting and get plain sheet adding magnesium stearate in the dried granule, the consumption of magnesium stearate is that 0.4-0.6% does particulate weight, with the film coating slurry with behind the plain coating tablets promptly.
Describedly get Herba Taraxaci, Thallus Laminariae (Thallus Eckloniae), Radix Trichosanthis, Caulis Spatholobi, Radix Paeoniae Rubra, Sargassum, Radix Rhapontici, the Radix Aucklandiae, Cortex Moutan, Spica Prunellae, Fructus Forsythiae, Flos Carthami to decoct with water collecting decoction be to decoct with water secondary, add for the first time the water that 8-12 doubly measures, decocted 2-4 hour after boiling, for the second time add 6-10 times of water gaging, the back of boiling decocted 1-3 hour.
Described film coating slurry is to be made by following processing step: the prompt color powder stirring and evenly mixing of adding in the 60-80% alcoholic solution that is configured to by purified water and 95% ethanol or in the water, in the 60-80% alcoholic solution or the weight ratio of water and prompt color powder be 8-15: 1.
Clinical trial below in conjunction with medicine of the present invention illustrates beneficial effect of the present invention.
The clinical trial of Drug therapy cystic hyperplasia of breast of the present invention is summed up:
Drug main of the present invention will be made up of Chinese medicines such as Cornu Cervi, Caulis Spatholobi, Radix Notoginseng, Sargassum, Radix Scrophulariae, Flos Carthamis, has hard masses softening and resolving, the eliminating carbuncle of invigorating blood circulation, and the function of heat-clearing and toxic substances removing is mainly used in the treatment cystic hyperplasia of breast, mainly investigates its health giving quality and untoward reaction.The method that contrasts non-blind method and open treatment is at random adopted in clinical trial, observes 200 examples altogether.
This institute has case all to meet the case choice criteria.
Diagnostic criteria: formulate with reference to " the clinical research guideline of new Chinese medicine treatment cystic hyperplasia of breast ".
One, test method:
(1) group technology: this test is finished jointly by two tame hospitals.Be divided into treatment group at random and matched group and open group at random according to the random table method.110 examples, matched group 30 examples, open group 60 examples are organized in treatment.
(2) Therapeutic Method: adopt the non-blind method that contrasts at random.
Treatment group medicine:, each 6, every day three times, oral by the medicine that the raw material and the preparation method of the embodiment of the invention one is prepared from.
The matched group medicine: XIAOHE PIAN, each 6, every day three times, oral.Authentication code is provided by Sichuan Guangda Pharmaceutical Co., Ltd: ZZ-5068-defends in the river the accurate word (1998) the 013613rd of medicine; Lot number: 990318.
(3) course of treatment: 30 days is a course of treatment.Observe a course of treatment, follow up a case by regular visits to a course of treatment.
(4) test routine number: 110 examples are organized in treatment at random, and matched group 30 examples are opened group 60 examples at random.
In the case of all tests, inpatient should be no less than 2/3 of total routine number.
(5) observation index
1. health giving quality observation
(1) situation of change before and after clinical symptoms, the sign treatment
(2) test rating: the situation of change before and after the treatment
2. safety detects:
1. general health check-up project.
2. blood, urine, just routine test.
The heart, liver, renal function chemical examination.
Two, curative effect judging standard:
Efficacy assessment standard with reference to treatment cyclomastopathy in " new Chinese medicine clinical guidance principle " is formulated this standard.
Recovery from illness: all symptoms of treatment back, sign all disappears, and integration is 0.
Produce effects: treatment back cardinal symptom, sign is most of to disappear, and integration descends 〉=2/3.
Effectively: treatment back symptom, sign partly disappears, and integration descends 〉=1/3.
Invalid: treatment back symptom, sign does not have obvious improvement or increases the weight of, and integration descends＜1/3.
Three, therapeutic outcome:
(1), respectively organize every tcm symptom, sign curative effect relatively:
Table 1 is respectively organized every tcm symptom, sign curative effect relatively
| Symptom and sign | Group | The example number | Before the treatment | After the treatment | In the group | |||||||
| +++ | ++ | + | - | +++ | ++ | + | - | U | P | |||
| Lump quality lump size | The open group of the open group of treatment group matched group treatment group matched group | 110 30 60 110 30 60 | 23 10 22 11 10 11 | 56 19 36 53 16 47 | 31 1 2 46 4 2 | 0 0 0 0 0 0 | 0 0 19 0 0 9 | 75 4 6 11 6 27 | 16 23 31 81 21 20 | 19 3 4 18 3 4 | 8.37 5.91 3.78 7.20 5.01 3.17 | ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 |
| Lump scope lump position lump pain lump is touched a tender spot | The open group of the open group for the treatment of group control group treatment group control group open group treatment group control group open group treatment group control group | 110 30 60 110 30 60 110 30 60 110 30 60 | 1 0 0 0 0 0 21 7 31 18 9 4 | 61 22 34 52 13 32 66 22 27 60 19 53 | 48 8 26 58 17 28 23 1 2 32 2 3 | 0 0 0 0 0 0 0 0 0 0 0 0 | 0 0 0 0 0 0 0 0 0 0 0 0 | 14 4 34 21 4 30 4 0 2 1 1 1 | 18 23 22 71 23 24 17 16 33 26 21 34 | 78 3 4 18 3 6 89 14 25 83 8 25 | 9.59 4.20 0.27 4.73 0.03 0.76 11.95 6.59 9.15 11.83 6.22 9.06 | ＜0.01 ＜0.01 ＞0.05 ＜0.01 ＞0.05 ＞0.05 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 |
Ridit analyzes: treatment group at random and comparison between matched group at random:
Lump scope: U=4.48 P＜0.01
Lump pain: U=6.59 P＜0.01
Lump is touched a tender spot: U=4.12 P＜0.01
As shown in Table 1, before and after treatment group at random and the treatment of control group, except that matched group to the improvement of the shared quadrant of lump not obvious, other symptoms, sign P＜0.01 that all has clear improvement in treatment group at random and the matched group.Compare significant difference P＜0.01 in scope of dwindling lump and alleviating pain tenderness between two groups.
(2), picture of the tongue, pulse condition change relatively before and after each group treatment
Picture of the tongue, pulse condition change relatively (N) before and after each group treatment of table 2
| Project | Group | The example number | Before the treatment | After the treatment | In the group | |||
| Normally | Unusually | Normally | Unusually | X 2 | P | |||
| The picture of the tongue pulse condition | The open group of treatment group matched group treatment group | 110 30 60 110 | 23 3 24 50 | 87 27 36 60 | 76 16 34 91 | 34 14 26 19 | 49.667 11.09 2.703 39.601 | ＜0.01 ＜0.01 ＞0.05 ＜0.01 |
| The open group of matched group | 30 60 | 12 43 | 18 17 | 26 43 | 4 17 | 12.12 0 | ＜0.01 ＞0.05 |
X
2Analyze: between treatment group at random and matched group:
Picture of the tongue: X
2=1.945 P＞0.05
Pulse condition: X
2=0.057 P＞0.05
As shown in Table 2, the picture of the tongue of treatment group at random there were significant differences P＜0.01 in the group before and after treatment, interior there were significant differences P＜0.01 of group before and after the pulse condition treatment; Matched group picture of the tongue there were significant differences P＜0.01 in the group before and after treatment at random, interior there were significant differences P＜0.01 of group before and after the pulse condition treatment.
(3), the variation of color ultrasound before and after the treatment group treatment:
This is organized and has all carried out color ultrasound or X line before all cases are treated, and detections such as B ultrasonic liquid crystal thermal imagery are diagnosed as chronic cystic hyperplasia of breast disease.Wherein 30 examples (also carry out before the treatment color ultrasound detect) are organized in treatment, have carried out treating the back color ultrasound and have detected, before treating back 28 example promptings and treating change similar, 1 routine lump slightly dwindles.1 routine lump disappears.
(4), safety detects:
To treatment group and matched group patient, carried out respectively before and after the treatment there is no abnormal change before and after routine blood test, routine urinalysis, liver function, renal function, the Electrocardiographic inspection treatment in the clinical experiment.See table 3 for details.
Security inspection (N) before and after the table 3 treatment group
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| The just conventional GPT BUN of routine blood test routine urinalysis Cr electrocardiogram | 80 80 80 50 50 50 30 | 80 80 80 50 50 50 30 | 0 0 0 0 0 0 0 | 80 80 80 50 50 50 30 | 0 0 0 0 0 0 0 |
Four, conclusion:
Medicine of the present invention is 85.5% to the total effective rate of blood stasis type cystic hyperplasia of breast, and cure-remarkable-effectiveness rate is 30%, compares with matched group, and is similar on total effective rate, but is better than matched group improving pain, touch a tender spot and dwindle on the lump scope.
The clinical trial of Drug therapy mastitis of the present invention is summed up:
Drug main of the present invention will be made up of Chinese medicines such as Cornu Cervi, Caulis Spatholobi, Radix Notoginseng, Sargassum, Radix Scrophulariae, Flos Carthamis, has hard masses softening and resolving, a function of the eliminating carbuncle of invigorating blood circulation, heat-clearing and toxic substances removing, be mainly used in control mastitis from the beginning of.This medicine is carried out clinical verification, mainly investigated its health giving quality and untoward reaction.The randomized controlled method is adopted in clinical trial, observes 60 examples altogether, and wherein 30 examples are organized in treatment, matched group 30 examples.And the treatment group is being dwindled the mastitis lump, alleviating mastitis and all is being higher than matched group on onset time, now the result is reported as follows.
This is tested all cases and all derives from my out-patient of institute, and case all meets the case standard of selecting.
One, case is selected:
Diagnostic criteria: formulate with reference to " the clinical guidance principles of new Chinese medicine treatment mastitis ".
Test case standard: meet primary disease tcm diagnosis standard and dialectical and, can include the test case in for strongly fragrant breast phase person (mastitis initial stage).
Tcm symptom scoring system and severity extent grade scale:
Mastalgia: 6 minutes: pain unbearably or be persistent ache
4 minutes: pain can restrain oneself or the time heavy when light
2 minutes: mild pain or cut in and out
0 minute: no pain
Breast caking: 6 minutes: caking＞5cm2 and harder or a plurality of caking
4 minutes: caking 〉=3cm2 also had certain degree of hardness
2 minutes: caking≤3cm2 and very not hard
0 minute: do not have caking
Milk is not smooth: 6 minutes: no milk is discharged, and sides such as the massage that needs to exert oneself go out
4 minutes: can discharge a small amount of milk
2 minutes: milk was more normal, and time reduces
0 minute: milk was discharged normal
Breast tenderness: 6 minutes: refuse pain
4 minutes: i.e. the pain of refusing but still can stand
2 minutes: the slight tenderness
0 minute: do not have and touch a tender spot
Breast redness: 6 minutes: breast height redness, skin is shinny, Pi Wengao
4 minutes: breast was obviously red and swollen
2 minutes: the little red back of breast mild swelling
0 minute: do not have red and swollen
Heating: 3 minutes: body temperature was more than 39 ℃
2 minutes: body temperature was more than 38.5 ℃
1 minute: on the body temperature 37
0 minute: body temperature was normal
Aversion to cold: 3 minutes: aversion to cold obviously need add clothing
2 minutes: though aversion to cold need not add clothing
1 minute: little sense aversion to cold
0 minute: no aversion to cold
General pain: 3 minutes: a body and pain and degree are more very
2 minutes: but body or but the headache, the pain can stand
1 minute: slight head or general pain
0 minute: general pain without a head
Thirsty: 3 minutes: mouthful-thirsty
2 minutes: thirsty drink
1 minute: mouthful little desire was thirsty
0 minute: no thirsty
Receive: 3 minutes: loss of appetite all day, feed day＜2 liang
2 minutes: see that food promptly detests, food still can, feed day＜4 liang
1 minute: anorexia, feed more normally reduced
0 minute: diet was normal
Dry stool: 3 minutes: a few days is not understood, and dry stool is and hard, and defecation is required great effort
2 minutes: a few days was not understood, and just only did and not hard, and defecation is not very required great effort
1 minute: stool only did and hard and can day separate
Red tongue with yellow fur: 3 minutes: red tongue with yellow fur and thick
2 minutes: red tongue with yellow fur
1 minute: but tongue is red or but yellow and thin fur or only has the tip of the tongue yellow and thin fur
0 minute: tongue fur was normal
Rapid pulse: 3 minutes: rapid pulse per minute 〉=120 time
2 minutes: rapid pulse per minute 〉=110 time
1 minute: rapid pulse per minute 〉=100 time
0 minute: arteries and veins was normal
Two, test method:
Group technology: be divided into treatment group and matched group according to the random table method.Treatment group 30 examples and matched group 30 examples adopt the randomized, double-blind method.
Therapeutic Method: adopt the randomized, double-blind method.
1, treatment group medicine:, each 6, every day three times, oral by the medicine that the raw material and the preparation method of the embodiment of the invention 13 is prepared from.
2, matched group medicine: XIAOHE PIAN, each 6, every day three times, oral.Authentication code is provided by Sichuan Guangda Pharmaceutical Co., Ltd: ZZ-5068-defends in the river the accurate word (1998) the 013613rd of medicine; Lot number: 990318.
The course of treatment: 7 days is a course of treatment, takes a course of treatment.
Test routine number: 30 examples are organized in treatment, matched group 30 examples.
Antibiotic is used: the two groups of antibiotic kinds used and dosage, medication time limit are kept in balance.
Three, curative effect determinate standard
1, clinical recovery: whole body and local transference cure, integration are 0, and the blood leukocytes sum is normal.
2, produce effects: General Symptoms disappears, and local red disappears, and pain obviously alleviates, and lump dwindles more than 70%, and the blood leukocytes sum is normal.Integration descends 〉=2/3.
3, effective: General Symptoms disappears, and is red, swollen, alleviation of pain is light, and lump dwindles more than 30%, and the blood leukocytes sum is near normal, integration decline 〉=1/3.
4, invalid: do not reach effective standard, integration descends＜1/3.
Four, therapeutic outcome:
(1), two groups of total effectses are relatively:
Table 1 liang group total effects relatively
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Cure-remarkable-effectiveness rate | Total effective rate |
| N(％) | N(％) | N(％) | N(％) | ％ | ％ | ||
| Treatment group matched group | 30 30 | 9(30.0) 4(13.3) | 9(30.0) 4(13.1) | 9(30.0) 16(53.3) | 3(10) 6(20.0) | 60.0 26.7 | 90.0 80.00 |
Ridit analyzes: compare between group: U=2.28 P＜0.05
By table 1 as seen, the treatment group obvious effective rate of healing is 60.00%, and total effective rate is 90.0%, and the obvious effective rate of matched group is 26.7%, and total effective rate is 80.0%.The analysis showed that through Ridit two groups have significant difference P＜0.05.
(2), two groups of every tcm symptoms, sign curative effects compare:
The table 2 liang every symptom of group, sign curative effect are relatively
| Symptom and sign | Group | The example number | Before the treatment | After the treatment | In the group | |||||||
| The not smooth breast tenderness breast redness of mastalgia breast caking milk | Treatment group treatment of control group group treatment of control group group treatment of control group group treatment of control group group | 30 30 30 30 30 30 30 30 30 | +++ | ++ | + | - | +++ | ++ | + | - | U | P |
| 0 0 4 2 0 0 0 0 0 | 22 18 23 14 21 14 18 13 13 | 2 12 0 0 6 12 5 12 15 | 0 0 0 0 1 3 3 4 0 | 0 0 0 0 0 0 0 0 0 | 0 0 3 0 0 0 0 0 1 | 6 7 11 18 7 6 8 8 5 | 24 23 16 12 23 24 22 22 24 | 6.35 6.08 6.19 6.71 6.12 5.37 5.56 4.86 5.83 | ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 | |||
| The thirsty indigestion and loss of appetite red tongue with yellowish fur arteries and veins number of just doing of fever with chilliness head bodily pain | Treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group control group | 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 | 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 | 17 2 3 0 4 6 9 7 5 15 10 11 9 5 5 2 1 | 9 27 27 9 7 7 2 13 11 8 7 1 11 7 19 7 6 | 0 0 0 21 19 17 19 10 14 7 13 8 10 18 6 20 22 | 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 | 0 0 0 0 2 0 0 2 1 2 7 3 6 2 4 1 0 | 17 19 23 3 6 5 5 7 11 10 8 7 8 12 17 1 4 | 13 11 7 27 22 25 25 21 18 18 15 20 16 16 9 28 26 | 5.57 2.88 2.08 1.34 0.75 2.01 1.68 2.63 1.22 3.46 0.68 3.01 1.39 0.10 0.74 1.77 0.95 | ＜0.01 ＜0.01 ＜0.05 ＞0.05 ＞0.05 ＜0.05 ＞0.05 ＜0.01 ＞0.05 ＜0.01 ＞0.05 ＜0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 | |
Ridit analyzes: between group:
Mastalgia: U=2.25 P＜0.05
Lump in breast: U=2.02 P＜0.05
Milk is not smooth: U=1.69 P＞0.05
Breast tenderness: U=2.89 P＜0.01
Breast redness: U=0.22 P＞0.05
Heating: U=0.27 P＞0.05
Aversion to cold: U=1.16 P＞0.05
General pain: U=0 P＞0.05
Thirsty: U=0.56 P＞0.05
Indigestion and loss of appetite: U=1.07 P＞0.05
Dry stool: U=1.03 P＞0.05
Red tongue with yellow fur: U=1.67 P＞0.05
Rapid pulse: U=0.42 P＞0.05
As shown in Table 2, before and after the treatment group treatment, except that tongue, arteries and veins being improved significantly, other are all improved significantly P＜0.01 and P＜0.05.And the correct general pain of matched group, thirsty, indigestion and loss of appetite, dry stool, tongue, arteries and veins do not have tangible improvement effect.Relatively, alleviating aspect the breast tenderness treatment group and matched group significant difference P＜0.01 between two groups.
(3), the curative effect of two groups of differences on treatment times relatively
The curative effect of table 3 liang group on different treatment times relatively
| Treatment time (my god) | Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate |
| N(％) | N(％) | N(％) | N(％) | (％) | |||
| 3 days 7 days | Treatment group treatment of control group group matched group | 30 30 30 30 | 0 0 9 5 | 0 0 9 4 | 20 11 9 16 | 10 19 3 5 |
Ridit analyzes: between group: 3 days U=2.01 P＜0.05
7 days U=1.92 P＜0.05
As shown in Table 3, curative effect there are no significant difference P＜0.05 during two groups of treatments 3 days and the 7th day.
(4), safety detects:
To treatment group and matched group patient, carried out respectively before and after the treatment there is no abnormal change before and after routine blood test, routine urinalysis, liver function, renal function, the Electrocardiographic inspection treatment in the clinical experiment.See table 4 for details.
(N) looked in safety procuratorial work before and after the table 4 treatment group
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| The routine blood test routine urinalysis | 30 20 | 5 20 | 24 0 | 30 20 | 0 0 |
| Just conventional GPT BUN | 20 20 20 | 20 20 20 | 0 0 0 | 20 20 20 | 0 0 0 |
Untoward reaction in 30 routine treatment groups, is not seen obvious adverse reaction, and before the treatment, routine blood test has 22 leukocyte counts to increase, and treats the back and recovers normal, treat preceding 20 examples and carried out urine, just conventional no abnormal, and still be normal after the treatment.
Five, discuss:
1. medicine of the present invention is 60.0% to the more obvious effective rate at mastitis initial stage, and total effective rate is 90.0%; The matched group obvious effective rate of healing is 80.0%, and total effective rate is 26.7%; Between two groups on total effects significant difference, the treatment group is higher than matched group.
2. the various tcm symptoms that medicine of the present invention was occurred the mastitis initial stage, sign etc. all improve significantly, and compare with matched group, are dwindling lump in breast, alleviate carbuncle of breast and go up bitterly and obviously be better than matched group.
3. Drug therapy mastitis of the present invention curative effect difference on different administration times, curative effect also has notable difference between identical time period group.Medication 3 days and medication are in the time of 7 days, and the treatment group all obviously is better than matched group.
4. medicine of the present invention is not seen obvious toxic-side effects and untoward reaction clinically.
By the above-mentioned clinical trial proof medicine of the present invention that medicine of the present invention is carried out is a kind of cystic hyperplasia of breast and effective Chinese medicine of mastitis for the treatment of, it is dwindling lump in breast, and alleviating carbuncle of breast, to go up effect bitterly remarkable, it rapid-action, patient's dose is few, and is safe.
The specific embodiment
Embodiment one
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=300: 200: 780: 80: 200: 200: 60: 390: 120: 160: 200: 280: 200: 80: 120: 67.4: 2022: 40.
Manufacturing method for above mentioned medicine comprises following processing step:
Get Radix Scrophulariae, Radix Notoginseng, Cornu Cervi mixing back pulverizing, it is standby to get fine powder;
Get Herba Taraxaci 200g, Thallus Laminariae (Thallus Eckloniae) 780g, Radix Trichosanthis 80g, Caulis Spatholobi 200g, Radix Paeoniae Rubra 60g, Sargassum 390g, Radix Rhapontici 120g, Radix Aucklandiae 160g, Cortex Moutan 280g, Spica Prunellae 200g, Fructus Forsythiae 80g, Flos Carthami 120g places the multipotency extraction pot to carry out reflux, extract,, extract twice, the water of 10 times of amounts for the first time, decocted 2-4 hour after boiling, add for the second time 6-10 times of water gaging, decocted 1-3 hour after boiling, filter, filter, the medicinal liquid vacuum decompression is concentrated, being concentrated into and measuring relative density with gravimeter 50-60 ℃ the time is the concentrated solution of 1.15-1.17, it is the extractum of 1.36-1.40 that concentrated solution is evaporated to the relative density of measuring 50-60 ℃ the time, extractum is mixed afterwards under 50-60 ℃ of temperature dry 5-15 hour rewinding then with above-mentioned fine powder, through pulverizing, sieve medicated powder, with medicated powder and 40gCaSO
4Mix with the 67.4g microcrystalline Cellulose, the alcoholic solution wetting agent that adds the 75-80% that is mixed with by 2022g95% second alcohol and water then stirs, sieve wet granular, wet granular is 50-60 ℃ in temperature to be descended dry 30-60 minute, granulate must be done granule, dried granule is added magnesium stearate mixing back tabletting get plain sheet, the consumption of magnesium stearate is that 0.4-0.6% does particulate weight;
The made membrane syrup: add prompt color powder stirring and evenly mixing in the alcoholic solution of the 60-80% that is configured to by purified water and 95% ethanol or 71% or water, 60-80% or 71% alcoholic solution or the weight ratio of water and prompt color powder are 8-15: 1 film coating is starched;
With film coating slurry with behind the plain coating tablets promptly.
Embodiment two
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=200: 300: 950: 120: 300: 300: 95: 480: 180: 240: 300: 380: 300: 120: 180: 130: 3000: 60.
Its preparation method is with embodiment one.
Embodiment three
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=400: 100: 600: 40: 100: 100: 25: 260: 80: 90: 100: 180: 100: 40: 80: 30: 1000: 20.
Its preparation method is with embodiment one.
Embodiment four
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=400: 300: 950: 120: 300: 300: 95: 480: 180: 240: 300: 380: 300: 120: 180: 130: 3000: 60.
Its preparation method is with embodiment one.
Embodiment five
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=200: 100: 600: 40: 100: 100: 25: 260: 80: 90: 100: 180: 100: 40: 80: 30: 1000: 20.
Its preparation method is with embodiment one.
Embodiment six
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=200: 300: 950: 40: 100: 300: 95: 480: 80: 90: 300: 380: 100: 120: 180: 30: 1000: 20.
Its preparation method is with embodiment one.
Embodiment seven
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=260: 220: 860: 120: 220: 220: 80: 430: 140: 180: 220: 310: 230: 100: 160: 90: 2100: 45.
Its preparation method is with embodiment one.
Embodiment eight
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=260: 160: 700: 60: 160: 160: 40: 330: 100: 140: 160: 240: 180: 60: 90: 50: 1500: 35.
Preparation method is with embodiment one.
Embodiment nine
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=340: 160: 700: 60: 160: 160: 40: 330: 100: 140: 160: 240: 180: 60: 90: 50: 1500: 35.
Preparation method is with embodiment one.
Embodiment ten
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=340: 220: 860: 120: 220: 220: 80: 430: 140: 180: 220: 310: 230: 100: 160: 90: 2100: 45.
Preparation method is with embodiment one.
Embodiment 11
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=290: 190: 810: 90: 190: 190: 55: 390: 125: 165: 190: 280: 200: 85: 135: 80: 1780: 38.
Preparation method is with embodiment one.
Embodiment 12
Medicine of the present invention is to count ratio by following raw materials in parts by weight to be prepared from:
Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=310: 180: 830: 100: 180: 170: 65: 360: 110: 155: 185: 270: 190: 75: 115: 60: 2000: 42.
Preparation method is with embodiment one.
Claims (6)
1, a kind of Chinese medicine for the treatment of cystic hyperplasia of breast and mastitis, it is to count ratio by following raw materials in parts by weight to be prepared from: Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=200-400: 100-300: 600-950: 40-120: 100-300: 100-300: 25-95: 260-480: 80-180: 90-240: 100-300: 180-380: 100-300: 40-120: 80-180: 30-130: 1000-3000: 20-60.
2, the Chinese medicine of treatment cystic hyperplasia of breast according to claim 1 and mastitis, the Chinese medicine that it is characterized in that described treatment cystic hyperplasia of breast and mastitis, it is to count ratio by following raw materials in parts by weight to be prepared from: Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=260-340: 160-220: 700-860: 60-120: 160-220: 160-220: 40-80: 330-430: 100-140: 140-180: 160-220: 240-310: 180-230: 60-100: 90-160: 50-90: 1500-2100: 35-45.
3, the Chinese medicine of treatment cystic hyperplasia of breast according to claim 1 and mastitis, the Chinese medicine that it is characterized in that described treatment cystic hyperplasia of breast and mastitis, it is to count ratio by following raw materials in parts by weight to be prepared from: Cornu Cervi: Herba Taraxaci: Thallus Laminariae (Thallus Eckloniae): Radix Trichosanthis: Caulis Spatholobi: Radix Notoginseng: Radix Paeoniae Rubra: Sargassum: Radix Rhapontici: the Radix Aucklandiae: Radix Scrophulariae: Cortex Moutan: Spica Prunellae: Fructus Forsythiae: Flos Carthami: microcrystalline Cellulose: 95% ethanol: CaSO
4=300: 200: 780: 80: 200: 200: 60: 390: 120: 160: 200: 280: 200: 80: 120: 67.4: 2022: 40.
4, the preparation method of the Film coated tablets of a kind of claim 1,2 or 3 described treatment cystic hyperplasia of breast and mastitis Chinese medicine, it comprises following processing step:
Get Radix Scrophulariae, Radix Notoginseng, Cornu Cervi mixing back pulverizing, it is standby to get fine powder;
Get Herba Taraxaci, Thallus Laminariae (Thallus Eckloniae), Radix Trichosanthis, Caulis Spatholobi, Radix Paeoniae Rubra, Sargassum, Radix Rhapontici, the Radix Aucklandiae, Cortex Moutan, Spica Prunellae, Fructus Forsythiae, Flos Carthami and decoct with water collecting decoction, filter, being concentrated into and measuring relative density with gravimeter 50-60 ℃ the time is the concentrated solution of 1.15-1.17, it is the extractum of 1.36-1.40 that concentrated solution is evaporated to the relative density of measuring 50-60 ℃ the time, extractum is mixed the back under 50-60 ℃ of temperature dry 5-15 hour with above-mentioned fine powder, rewinding then, through pulverize, sieve medicated powder, with medicated powder and CaSO
4Mix with microcrystalline Cellulose, the alcoholic solution wetting agent that adds the 75-80% that is made by 95% ethanol and water planting then stirs, sieve wet granular, wet granular is 50-60 ℃ in temperature to be descended dry 30-60 minute, granulate must be done granule, dried granule is added magnesium stearate mix the back tabletting and get plain sheet, the consumption of magnesium stearate is that 0.4-0.6% does particulate weight, with the film coating slurry with behind the plain coating tablets promptly.
5, the preparation method of treatment cystic hyperplasia of breast according to claim 4 and mastitis Chinese medicine Film coated tablets, it is characterized in that describedly getting Herba Taraxaci, Thallus Laminariae (Thallus Eckloniae), Radix Trichosanthis, Caulis Spatholobi, Radix Paeoniae Rubra, Sargassum, Radix Rhapontici, the Radix Aucklandiae, Cortex Moutan, Spica Prunellae, Fructus Forsythiae, Flos Carthami to decoct with water collecting decoction being to decoct with water secondary, add for the first time the water that 8-12 doubly measures, decocted 2-4 hour after boiling, for the second time add 6-10 times of water gaging, the back of boiling decocted 1-3 hour.
6, the preparation method of treatment cystic hyperplasia of breast according to claim 4 and mastitis Chinese medicine Film coated tablets, it is characterized in that described film coating slurry is to be made by following processing step: add prompt color powder stirring and evenly mixing in 60-80%% alcoholic solution that is configured to by purified water and 95% ethanol or water, the weight ratio of 60-80%% alcoholic solution or water and prompt color powder is 8-15: 1.
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| CN102038799A (en) * | 2010-12-07 | 2011-05-04 | 哈尔滨泰华药业股份有限公司 | Application of breast lump-elimination preparation in preparing medicines for treating dysmenorrhea |
| CN102218099A (en) * | 2010-08-13 | 2011-10-19 | 辽宁玉皇药业有限公司 | Rupixiao plaster and its application in plaster preparation |
| CN103110893A (en) * | 2013-02-09 | 2013-05-22 | 陈登宏 | Preparation method of traditional Chinese medicine lotion for treating heat toxicity type acute mammitis |
| CN110882235A (en) * | 2019-12-30 | 2020-03-17 | 沈阳红药集团股份有限公司 | Breast nodule eliminating cataplasm and its preparation method |
| CN113577221A (en) * | 2021-07-23 | 2021-11-02 | 程广 | A Chinese medicinal composition for treating mastitis, hyperplasia of mammary glands, breast nodule and menstrual breast pain |
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2005
- 2005-11-23 CN CNB2005100477914A patent/CN100502843C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102218099A (en) * | 2010-08-13 | 2011-10-19 | 辽宁玉皇药业有限公司 | Rupixiao plaster and its application in plaster preparation |
| CN102038799A (en) * | 2010-12-07 | 2011-05-04 | 哈尔滨泰华药业股份有限公司 | Application of breast lump-elimination preparation in preparing medicines for treating dysmenorrhea |
| CN102038799B (en) * | 2010-12-07 | 2012-07-04 | 哈尔滨泰华药业股份有限公司 | Application of breast lump-elimination preparation in preparing medicines for treating dysmenorrhea |
| CN103110893A (en) * | 2013-02-09 | 2013-05-22 | 陈登宏 | Preparation method of traditional Chinese medicine lotion for treating heat toxicity type acute mammitis |
| CN110882235A (en) * | 2019-12-30 | 2020-03-17 | 沈阳红药集团股份有限公司 | Breast nodule eliminating cataplasm and its preparation method |
| CN113577221A (en) * | 2021-07-23 | 2021-11-02 | 程广 | A Chinese medicinal composition for treating mastitis, hyperplasia of mammary glands, breast nodule and menstrual breast pain |
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|---|---|
| CN100502843C (en) | 2009-06-24 |
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