CN102258603B - Medicinal preparation for treating plasma cell mastitis and preparation method thereof - Google Patents
Medicinal preparation for treating plasma cell mastitis and preparation method thereof Download PDFInfo
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Abstract
The invention, belonging to the field of traditional Chinese medicine pharmacy, relates to a medicinal preparation for treating plasma cell mastitis and a preparation method thereof. The medicinal preparation for treating plasma cell mastitis takes liver smoothing, heat clearing, vigoration of blood circulation and bind dissipating as therapeutic principles, and comprises the following traditional Chinese pharmaceutical ingredients: radix bupleuri, scutellaria baicalensis, cape jasmine fruit, cortex moutan, red paeony root, dandelion, health hawthorn, hedyotidis herba and other auxiliary materials. Clinical outcomes show that the medicinal preparation can clear away hepatic fire and stomach toxic heat to achieve the effects of smoothening liver-Qi, strengthening spleen-Qi and dispersing carbuncle and swelling, and can effectively reduce inflammatory response and alleviate clinical symptoms, prevent the further progress of the disease, and mitigate the mental pressure of the patient. The medicinal preparation has the advantages of convenient taking, less dosage and no side effects of long term dosages, and has good comments made by patients.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of pharmaceutical preparation for the treatment of plasma cell mastitis and preparation method thereof.
Background technology:
Plasma cell mastitis clinical under aperiodicity mastalgia, nipple discharge, the mammary areola lump, the other abscess of mammary areola and areola of breast fistula as feature.How to fall ill at non-lactation period or non-pregnancy.Can trace back to the twenties in last century for the understanding of this disease abroad.Nineteen twenty-three Bloodgood can touch under the skin in mammary areola district that to expand disappointed breast duct streak, and swollen thing causes skin and is brownish red tubulose lump, is called venectasia swollen (the varicocele tumor); Nineteen twenty-five Ewing finds in focus, a large amount of plasmocyte infiltrating is arranged under mirror, and called after plasma cell mastitis (plasma cellmastitis) first.1933, Adair found primary disease to late stage, managed week take plasmocyte infiltrating as main inflammatory reaction but the excitor substance discharger in its dilating catheter causes outward, was called plasma cell mastitis (plasma cellmaslitis).
In traditional Chinese medical science successive dynasties document, not yet find so far the record with the similar disease of primary disease.By the treatment of modern TCM for this disease, progressively summing up experience, 1958 by professor's Gu Baihua reported first at home, according to its clinical manifestation and called after " chronic recurrent mammary gland fistulae is with retracted nipple ".The eighties in 20th century, Gu Baihua, Lu Deming etc. includes primary disease first in " practical Surgery of Chinese Medicine ", " acne acute mastitis " by name.
Modern medicine not yet has clearly final conclusion to this sick etiology and pathogenesis, may be relevant with congenital breast deformity, suckling obstacle, breast wound, inflammation, endocrine disturbance and mammary gland degeneration.Mammiplasia is abnormal, epithelium is crossed keratinization and chemical fibre underwear fiber to cause latex dust to block ischesis, ductal ectasia, galactophoritis and chronic granuloma mastitis and even secondary abscess and fistula be primary disease pathological process in various degree.Local conduit drainage difficulty, the secretions stasis of blood is stagnant and block and cause local ductal ectasia, and in tube chamber, neutral fat stimulates tube wall, proliferation of fibrous tissue and then destroy tube wall and enter a matter and cause the aseptic inflammation reaction.Other factors may be the major reason of primary disease recurrence as smoking etc.
Doctor trained in Western medicine is clinical often uses antibiotic therapy in this disease red and swollen heat pain period, but poor effect, and patient's symptom is normal without obviously improving, or symptom take a turn for the better after recurrence again soon.Expectant treatment is invalid, when lump expanded range or red and swollen diabrosis, abscess formation, doctor trained in Western medicine thinks that unique Therapeutic Method is operation, segmental mastectomy or conduit excision are done in treatment more, the person of being in a bad way need go simple mastectomy, affected the normal appearance of breast, larger for patient's physiology and psychological impact.
The traditional Chinese medical science thinks that generation, development and the liver stomach of plasma cell mastitis is in close relations.The strongly fragrant soil of wood is stopped up, and the stagnation of liver-QI gastric heat is the primary disease pathogenesis; Crater nipple, newborn network lose in unobstructed be the morbidity primary condition.Congenital defect, crater nipple or deformity cause newborn network obstructed, the latex dust drainage difficulty, internal injury caused by excess of seven emotions, the unsuccessful depression of liver-QI that causes of feelings will in addition, stagnation of QI due to depression of the liver, nutrient blood is from, stagnation of QI-blood, lump formation due to accumulation of pathogens, strongly fragrant heat-transformation of a specified duration is steamed and is made the meat corruption and form abscess, fistulization after bursting.Therefore stagnated heat of liver channel is the main pathogenesis of this disease.Clinical many employing Shugan Qingres, blood circulation promoting and dispersing pathogen accumulation are the rule for the treatment of, discharge phase, lump phase, fistula phase in disease treat, and let out clearly the fire of Liver Channel, stomach through pyretic toxicity to reach, and the irritability bar is reached, the strong fortune of temper promotes disease improvement recovery, Shorten the Treatment Process, lenitive purpose.But Chinese medicine decoction needs boil medicine every day, exists to take inconvenient shortcoming
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical preparation for the treatment of plasma cell mastitis of safe and effective and taking convenience, and preparation method thereof.
The present invention according to the traditional Chinese medical science to its relevant etiology and pathogenesis of described cellularity mastitis, the elaboration of clinical manifestation and traditional Chinese medical therapeutic program.Motherland's medical science thinks that this disease belongs to congenital defect, and crater nipple or deformity cause newborn network obstructed, the latex dust drainage difficulty, internal injury caused by excess of seven emotions, the unsuccessful depression of liver-QI that causes of feelings will in addition, stagnation of QI due to depression of the liver, nutrient blood is not from, stagnation of QI-blood, lump formation due to accumulation of pathogens, strongly fragrant heat-transformation of a specified duration is steamed the corruption of wine meat and is formed abscess, fistulization after bursting.Therefore stagnated heat of liver channel is the main pathogenesis of this disease.
The present invention is take Shugan Qingre, blood circulation promoting and dispersing pathogen accumulation as the rule for the treatment of, made the Chinese medicine preparation for the treatment of plasma cell inflammation by medicine effect composition and pharmaceutical carrier, described effective ingredient is made by the extract of following raw material of Chinese medicine medicine: Radix Bupleuri, Radix Scutellariae, Fructus Gardeniae, Cortex Moutan, Radix Paeoniae Rubra, Herba Taraxaci, Fructus Crataegi, Herba Hedyotidis Diffusae.
Pharmaceutical preparation of the present invention, adopt the crude drug of making effective ingredient and the pharmaceutical carrier of following weight parts to make:
Radix Bupleuri 1-3 part, Radix Scutellariae 1-3 part, Fructus Gardeniae 1-3 part, Cortex Moutan 1-3 part, Radix Paeoniae Rubra 1-3 part, Herba Taraxaci 1-3 part, Fructus Crataegi 1-3 part, Herba Hedyotidis Diffusae 1-3 part, remaining is pharmaceutic adjuvant.
In the present invention, the weight portion proportioning of preferred feedstock medicine is: 2 parts of Radix Bupleuri, 1 part of Radix Scutellariae, 1 part of Fructus Gardeniae, 2 parts of Cortex Moutans, 3 parts of Radix Paeoniae Rubra, 3 parts of Herba Taraxacis, 3 parts of Fructus Crataegi, 3 parts of Herba Hedyotidis Diffusae.
In the present invention, pharmaceutic adjuvant is selected from mannitol, lactose, cane sugar powder, magnesium stearate, aspartame, Mentholum and/or oleum Citri sinensis essence.
Raw medicinal material involved in the present invention is recorded Chinese medicine by Chinese Pharmacopoeia one one of version in 2000, and meets the pharmacopeia prescription.
Pharmaceutical preparation of the present invention prepares by following method:
Get above-mentioned half amount of formula ratio crude drug, add water 3-8 and doubly measure, after soaking half an hour, decoct 45min, then add water 3-8 and doubly measure, decoct 30min, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder, crosses 80 orders; Second half crude drug was pulverized 80 orders, used CO
60Sterilization (irradiation dose 8k), mixed with extract powder, add mannitol, lactose, cane sugar powder, aspartame, Mentholum, after mix homogeneously with 60～70% ethanol as the binding agent granulation.Granular preparation is the 10g/ bag.
The present invention adopts conventional preparation process, adds molding adjuvant or taste masking adjuvant, the pharmaceutical dosage forms such as granulation agent, tablet, capsule, oral liquid.
Chinese medicine preparation of the present invention is through clinical trial, and result shows, can let out clearly the fire of Liver Channel, stomach through pyretic toxicity, and the irritability bar is reached, the strong fortune of temper, carbuncle dissipates, and reaction effectively can reduce inflammation, alleviate clinical symptoms, prevent further developing of the state of an illness, alleviate patient's mental pressure.
Preparation taking convenience of the present invention, dose is few, and long-term taking has no side effect, and the patient assessment is good.
The specific embodiment
Embodiment 1
1 part of Radix Bupleuri, 1 part of Radix Scutellariae, 1 part of Fructus Gardeniae, 1 part of Cortex Moutan, 1 part of Radix Paeoniae Rubra, 1 part of Herba Taraxaci, 1 part of Fructus Crataegi, 1 part of Herba Hedyotidis Diffusae, remaining is pharmaceutic adjuvant.
Get above-mentioned half amount of weight portion crude drug, add 3 times of amounts of water, after soaking half an hour, decoct 45min, then add 3 times of amounts of water, decoct 30min, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, used CO
60Sterilization, irradiation dose 8k, mixed with extract powder, add mannitol, lactose, cane sugar powder, aspartame, Mentholum, after mix homogeneously with 60% ethanol as the binding agent granulation.Granular preparation is the 10g/ bag.
Embodiment 2
3 parts of Radix Bupleuri, 3 parts of Radix Scutellariaes, 3 parts of Fructus Gardeniae, 3 parts of Cortex Moutans, 3 parts of Radix Paeoniae Rubra, 3 parts of Herba Taraxacis, 3 parts of Fructus Crataegi, 3 parts of Herba Hedyotidis Diffusae, remaining is pharmaceutic adjuvant.
Get above-mentioned above-mentioned half amount of weight portion crude drug of getting, add 8 times of amounts of water, after soaking half an hour, decoct 45min, then add 8 times of amounts of water, decoct 30min, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, used CO
60Sterilization, irradiation dose 8k, mixed with extract powder, add mannitol, lactose, cane sugar powder, aspartame, Mentholum, after mix homogeneously with 70% ethanol as the binding agent granulation.
Embodiment 3
2 parts of Radix Bupleuri, 1 part of Radix Scutellariae, 1 part of Fructus Gardeniae, 2 parts of Cortex Moutans, 3 parts of Radix Paeoniae Rubra, 3 parts of Herba Taraxacis, 3 parts of Fructus Crataegi, 3 parts of Herba Hedyotidis Diffusae, remaining is pharmaceutic adjuvant.
Get above-mentioned half amount of weight portion crude drug, add 8 times of amounts of water, after soaking half an hour, decoct 45min, then add 8 times of amounts of water, decoct 30min, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, used CO
60Sterilization irradiation dose 8k, mixed with extract powder, add mannitol, lactose, cane sugar powder, aspartame, Mentholum, after mix homogeneously with 70% ethanol as the binding agent granulation.
Embodiment 4 clinical experimental studies
Observe preparation for treating plasma cell mastitis patient of the present invention 84 examples, the symptom and sign for the treatment of Patients Before And After is carried out integration, observe anxiety simultaneously, self rating depression is divided, and follow up a case by regular visits to treating rear patient, understand the disease relapse situation.
1, case is selected
Inclusion criteria: the out-patient meets the female patient of former plasma cell mastitis.Diagnostic criteria is as follows:
1) morbidity is comparatively common with a side areola of breast, also has bilateral to fall ill simultaneously.The patient can have the slag specimen material secretion with stink often with the retracted nipple history in the nipple of depression.Small number of patients is courage and uprightness or water sample with nipple discharge.
2) mammary areola is other caking pain, and color of the leather is little red, and approximately 7-10 day becomes pus.Pus band frowziness after bursting does not close up for a long time, or recurrence again after healing.Heating, headache are arranged during suppuration.
3) outbreak repeatedly, can cause cicatrization, stiff lump occurs at areola of breast, and with the skin adhesion.
4) do not close up for a long time after bursting, form mammary fistula, it is characterized in that probeing into from the skin ulcer hole with the bulb filamentary silver, can pass from nipple.
5) mammary gland B ultrasonic, the molybdenum palladium is taken the photograph sheet, MRI helps diagnosis, and histopathology can be clarified a diagnosis.
This diagnostic criteria is with reference to " disease of tcm conventional treatment ", and passes through discussion in the 8th national breast disease Professional Committee meeting in July, 2002.
Exclusion standard: the person that do not meet the inclusive criteria; The organic heart, cerebrovascular disease and serious respiratory system, digestive system, blood system, urinary system, nervous system, endocrinopathy are arranged, severe mental sickness person; Gestation or women breast-feeding their children; Data not umbra is rung the observer; Medication can't not judge curative effect person in accordance with regulations.
2, observation index
1) clinical observation on the therapeutic effect
Formulate acne acute mastitis tcm symptom somatic feature score tables (CRF table) (as shown in table 1) according to primary disease Standards of Chinese Medical Syndrome Differentiation and 2002 " new Chinese medicine guideline of clinical investigations ", symptom and sign to the treatment Patients Before And After carries out integration, observes therapeutic effect.Follow up a case by regular visits to treating rear patient, understand the disease relapse situation.
(1) clinical efficacy standard:
Cure: lump disappears, the fistula healing.
Take a turn for the better: red heat pain disappears, and lump dwindles, and fistula is closely healed.
Do not heal: lump does not disappear, and fistula is not healed.
(2) integration criterion of therapeutical effect:
Formulate acne acute mastitis tcm symptom somatic feature score tables (CRF table) (as shown in table 1) according to primary disease Standards of Chinese Medical Syndrome Differentiation and 2002 " new Chinese medicine guideline of clinical investigations ", represent each grade score value with 0,2,4,6 respectively according to each symptom and sign character degree.Carry out the curative effect judgement according to the curative effect rate, be divided into healing, produce effects, effective, invalid four grades.Curative effect rate=[integration before (integration after integration before treatment-treatment)/treatment] * 100% keeps 2 significant digits.
Cure: the symptom and sign integration reduces 〉=90%, and the breast congestion and swelling pain disappears, the fistula healing.
Produce effects: the symptom and sign integration reduces 〉=60%,＜90%, and the most of healing of fistula have and shallowly do not heal in the open sore part, or stiff piece does not disappear.
Effectively: the symptom and sign integration reduces 〉=30%,＜60%, and breast swell and pain alleviates, and fistula, wound surface partly heal.
Invalid: symptom and sign integration＜30%, or extent of disease enlarges.
Total effective rate=(enter the produce effects number of cases of the healing number of cases of statistics+enter statistics+enter effective number of cases of statistics)/the enter number of cases of statistics.
2) by Zung establishment, self rating depressive scale (Self-Rating Depression Scale, SDS), Analysisof Self-rating Anxiety Scale (Self-Rating Anxiety Scale, SAS).SDS and SAS all comprise 20 projects, are respectively used to evaluate the subjective feeling of depressed patient or Anxiety Patients.
Adopt way of questionnaires inquiry plasma cell mastitis patient, whipped up under the guidance of unified instruction language by the investigator, according to the practical situation in a nearly week, each project of scale is made independent evaluation.Observe SDS, SAS scoring.The SDS scoring was considered to depressive symptom more than 41 minutes, and the SAS scoring was considered to anxiety symptom more than 40 minutes.
3, method of administration
Preparation group 84 people of the present invention: take preparation granules of the present invention, 2 bag bid, total amount is 40g/ day.
4, statistical analysis
Measurement data with t check, ranked data with Ridit check, enumeration data X
2Check adopts the SPSS13.0 statistical software to add up.
Result shows: after preparation granules treatment of the present invention, compare before patient's clinical symptoms sign and treatment and have clear improvement.The Ridit assay shows: compared significant difference (P＜0.05) after crater nipple, lump in breast, mastalgia, galactapostema, the treatment of breast fistular symptom with before treatment.After preparation granules treatment of the present invention, SDS scoring, SAS scoring reduce before treatment, obviously improve depressed, anxiety symptom, have statistically meaning (P＜0.01).
Table 1 is the comparison of the tcm clinical practice symptom classification situation before and after treatment.
Table 1
In table, represent each grade score value with 0,2,4,6 respectively according to each symptom and sign character degree.
The present invention is with every symptom and sign integration addition before and after patient treatment, and computation of mean values, and result represents with x ± s.The t assay: after treatment, patient's symptom and sign integration significantly lower than before treatment (P＜0.001), has significant difference.
Table 2 is symptom and sign integral contrasts before and after acne acute mastitis patient treatment.
Table 2
Preparation group patient mean treatment natural law of the present invention is 35.57 (81-11) sky.The clinical recovery rate is 85.71%, and total effective rate is 100%.
Table 3 is the statistical result of plasma cell mastitis clinical efficacy.
Table 3
The present invention follows up a case by regular visits to the plasma cell mastitis patient after preparation for treating of the present invention, follows up a case by regular visits to 3 months time to 4 years, and follow-up method comprises the person that comes the Out-patient Department, carries out state of an illness inquiry and health check-up, Effect of follow-up visit by telephone, follow-up rate 100%.In 42 routine patients, have 1 example recurrence, total relapse rate is 1.19% (1/84).This example patient is recurrence in postoperative half a year, in the outpatient service incision and drainage and change dressings, all fully recovers through retreatment.Table 4 is Patients on Recurrence situations.
Table 4
The present invention marks to the depressed mood for the treatment of forward and backward patient, psychomotor aspect, and result shows, to after treatment the scoring of depressed mood before treatment, psychomotor aspect reduction is all arranged, P＜0.01; The physical symptom scoring reduces, P＜0.05.
Table 5 is comparisons that the forward and backward depressive symptom scoring for the treatment of changes
Table 5
*P＜0.05；**P＜0.01
The present invention marks to the anxiety symptom for the treatment of forward and backward patient, the result demonstration, and after treatment, the mental symptom of the front anxiety neurosis for the treatment of, somatization scoring all have reduction, P＜0.01.
Table 6 is comparisons that before and after treatment, the anxiety symptom scoring changes
Table 6
**P＜0.01
Claims (5)
1. pharmaceutical preparation for the treatment of plasma cell mastitis, made by effective ingredient and pharmaceutical carrier, it is characterized in that, described effective ingredient is made by the extract of the raw material of Chinese medicine medicine of following weight parts: Radix Bupleuri 1-3 part, Radix Scutellariae 1-3 part, Fructus Gardeniae 1-3 part, Cortex Moutan 1-3 part, Radix Paeoniae Rubra 1-3 part, Herba Taraxaci 1-3 part, Fructus Crataegi 1-3 part, Herba Hedyotidis Diffusae 1-3 part.
2. by the pharmaceutical preparation for the treatment of plasma cell mastitis claimed in claim 1, it is characterized in that, the described weight portion of making the crude drug of effective ingredient is:
2 parts of Radix Bupleuri, 1 part of Radix Scutellariae, 1 part of Fructus Gardeniae, 2 parts of Cortex Moutans, 3 parts of Radix Paeoniae Rubra, 3 parts of Herba Taraxacis, 3 parts of Fructus Crataegi, 3 parts of Herba Hedyotidis Diffusae.
3. by the pharmaceutical preparation for the treatment of plasma cell mastitis claimed in claim 1, it is characterized in that, described pharmaceutical carrier is selected from mannitol, lactose, cane sugar powder, magnesium stearate, aspartame, Mentholum and/or oleum Citri sinensis essence.
4. the preparation method of the pharmaceutical preparation of the described treatment plasma cell mastitis of claim 1 or 2, is characterized in that, it comprises the steps:
Get half amount of formula ratio crude drug, add water 3-8 and doubly measure, after soaking half an hour, decoct 45min, then add water 3-8 and doubly measure, decoct 30min, filter, merge decoction liquor, concentrating under reduced pressure, drying under reduced pressure gets dry extract, is ground into fine powder and crosses 80 orders; Second half crude drug was pulverized 80 orders, with cobalt-60 sterilization, irradiation dose 8k, mixed with extract powder, add mannitol, lactose, cane sugar powder, aspartame, Mentholum, after mix homogeneously with 60～70% ethanol as the binding agent granulation, or add molding adjuvant or taste masking adjuvant, granulation agent, tablet, capsule or oral liquid.
5. by the method for claim 4, it is characterized in that, the metering of described granular preparation is the 10g/ bag.
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| CN103381210B (en) * | 2012-05-04 | 2015-02-25 | 上海中医药大学附属曙光医院 | Traditional Chinese medicine preparation for treating plasma cell mastitis, and preparation method thereof |
| CN103877342B (en) * | 2014-04-01 | 2016-04-06 | 岳卫霞 | A kind of medicament for the treatment of plasma cell mastitis |
| CN105056201A (en) * | 2015-09-14 | 2015-11-18 | 鞠茂秀 | Chinese herba preparation for curing plasma cell mastitis and preparation method thereof |
| CN105250528A (en) * | 2015-10-19 | 2016-01-20 | 青岛市中心医院 | Medicine composition for treating plasma cell mastitis and application of medicine composition |
| CN106728434A (en) * | 2016-12-13 | 2017-05-31 | 黑龙江中医药大学 | Chinese medicine preparation for treating mastitis |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1442175A (en) * | 2003-04-07 | 2003-09-17 | 杨秀云 | Chinese medicine for treating mammary gland foliole proliferation |
| CN101524464A (en) * | 2009-04-07 | 2009-09-09 | 朱亚夫 | Pure traditional Chinese medicine composition for treating female breast diseases and pure traditional Chinese medicine preparation prepared thereby |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1442175A (en) * | 2003-04-07 | 2003-09-17 | 杨秀云 | Chinese medicine for treating mammary gland foliole proliferation |
| CN101524464A (en) * | 2009-04-07 | 2009-09-09 | 朱亚夫 | Pure traditional Chinese medicine composition for treating female breast diseases and pure traditional Chinese medicine preparation prepared thereby |
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