CN101549075A - Traditional Chinese medicine composition for treating mammary gland hyperplasia and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating mammary gland hyperplasia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating mammary gland hyperplasia, which is prepared from the following four materials: Cyperus Rotundus L. 3-10, Ligusticum wallichii 2-8, tangerine seed 2-8 and gotu kola 10-30. The invention further discloses the preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition aims the pathogenesis characteristics of the liver depression blood stasis and vital energy retardation type mammary gland hyperplasia, has the curative effects of coursing liver, rectifying qi, dissipating binds and relieving pain. The traditional Chinese medicine composition preparation in the invention achieves the characteristics of carrying and taking convenience, controllable quality and good curative effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly a kind of Chinese medicine composition for the treatment of cyclomastopathy and preparation method thereof.
Background technology
Cyclomastopathy be mammary gland tissue a kind of be non-inflammation, the proliferative lesion of non-tumor again, its Clinical symptoms is distending pain of the breast, lump in breast.Primary disease is to be the general name of the class disease that changes of basic pathology with the epithelial cell of mammary gland acinus, conduit and connective tissue proliferation, belongs to the category of the traditional Chinese medical science " nodules of the breast ", according to its etiology and pathogenesis, can be divided into liver energy stagnation type, expectorant stasis of blood type, Chong and Ren channel disorder type.The morbidity of cyclomastopathy thinks relevant with endocrine disturbance and Nervous and Mental Factors at present more, patient's body inner estrogen is too high, progestogen are very few or two hormones between inharmonious, and mammary gland tissue all can cause mammary gland essence generation hypertrophy to the estrogen extrasensitivity.
Cyclomastopathy is between twenty and fifty women's a kind of commonly encountered diseases, a frequently-occurring disease, accounts for the first place of mastopathy.Variation along with social environment, natural environment, the quickening of rhythm of life, the enhancing of competitive spirit and the change of dietary structure, the sickness rate of cyclomastopathy has the trend that rises year by year, according to its sickness rate of domestic report is about 10%, wherein 2%～4% cystic hyperplasia initiation canceration can take place, and women's physical and mental health in serious threat, causes showing great attention to of doctor and patient.Therefore, raising is most important to the curative effect of cyclomastopathy.
Doctor trained in Western medicine does not still have the definite effective Therapeutic Method to cyclomastopathy at present.General clinically slight can the treating of symptom; Symptom than the loud work of ghost image, give birth to the reviver, based on Drug therapy, adopt Hormone Replacement Therapy, but side effect is big, and uncertain therapeutic efficacy cuts more, do not consolidate, may cause the further disorder of endocrine function; The height hypertrophy is had the tendency person of cancerating, then adopt operative therapy, but the relapse rate height is not easy for patients to accept.The Chinese traditional treatment primary disease adopts the method for dispersing the stagnated live-QI to relieve the stagnation of QI, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving more, though certain curative effect can be arranged, not from the starting with of morbidity at all, i.e. deficiency of the liver and kindey, Chong and Ren channel disorder, thereby can't reach better therapeutic.
Summary of the invention
The purpose of this invention is to provide and a kind ofly have regulating functional activities of qi, make Chinese medicine composition of the treatment cyclomastopathy that stagnation of liver-QI can be separated, the stagnation of QI can be relaxed, pain must be ended, lump can disappear and preparation method thereof, the western medicine therapy side effect that solves existing treatment cyclomastopathy is big, the defective that most tcm therapies are not started with the morbidity of deficiency of the liver and kindey, Chong and Ren channel disorder at all.
For achieving the above object, the Chinese medicine composition of treatment cyclomastopathy provided by the invention is made by four flavor raw materials of following portions by weight: Rhizoma Cyperi 3～10, Rhizoma Chuanxiong 2～8, Semen Citri Reticulatae 2～8, Herba Centellae 10～30.
The Chinese medicine composition of treatment cyclomastopathy of the present invention is preferably made by four flavor raw materials of following portions by weight: Rhizoma Cyperi 4～8, Rhizoma Chuanxiong 3～6, Semen Citri Reticulatae 3～6, Herba Centellae 15～22.
The Chinese medicine composition of treatment cyclomastopathy of the present invention is made by four flavor raw materials of following portions by weight more: Rhizoma Cyperi 6, Rhizoma Chuanxiong 4, Semen Citri Reticulatae 4, Herba Centellae 18.
The medicinal liquid of the Chinese medicine composition of treatment cyclomastopathy of the present invention, extractum, medicated powder etc. can be made into various oral formulations, are tablet, granule, capsule or oral liquid etc. preferably, are capsule more.
The present invention also further provides the preparation method of the Chinese medicine composition of above-mentioned treatment cyclomastopathy:
1. the preparation of capsule:
Take by weighing Rhizoma Cyperi, Rhizoma Chuanxiong, Semen Citri Reticulatae, Herba Centellae by weight; Rhizoma Cyperi is added 5～7 times of water distillations 4-6 hour, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then, and the medical filtration after the distillation gets filtrate A; Medicinal residues add 4-6 times of decocting and boiled 1-2 hour, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, the extractum G that it is 1.10-1.12 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 10-14 hour, C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 50-95% is extracted, filter filtrate recycling ethanol afterwards, filtrate D, the thick paste J that it is 1.30-1.32 that merging filtrate C and filtrate D, the liquor C after the merging and filtrate D concentrating under reduced pressure become 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With the Herba Centellae extracting in water, filter to get filtrate, it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, the ethanol of Jia Ruing is 60% to containing the alcohol amount afterwards, left standstill 10-14 hour, and filtered filtrate recycling ethanol, it is the thick paste I of 0.16-1.10 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, and first concentration with 3 times of resin bed volumes is 0.2% NaOH solution flushing, extremely neutral with the purified water flushing then, with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes again, the eluent concentrating under reduced pressure becomes thick paste, drying, dried cream powder are broken into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add adjuvant, make granule, drying adds above-mentioned standby nutgrass galingale oil-beta cyclodextrin clathrate, and mixing incapsulates, promptly.
2. the preparation of granule:
With above-mentioned fine powder E and fine powder F mix homogeneously, add adjuvant, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate in the dried granule, and mixing is used the compositing aluminium bag packing, promptly.
3. the preparation of tablet:
With above-mentioned fine powder E and fine powder F mix homogeneously, add adjuvant, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate in the dried granule, mixing, tabletting, packing again behind slice, thin piece packing or the bag film-coat, promptly.
4. the preparation of oral liquid:
Get extractum J and thick paste I behind the concentrating under reduced pressure in the capsule preparation, merge the back thin up, add antiseptic commonly used and correctives again, supply full dose with water and make oral liquid.
Wherein, above-mentioned adjuvant comprises inert filler or diluent etc., and as lactose, starch, dextrin, mannitol etc., the ratio of used adjuvant and above-mentioned dried cream powder is in 1: 1 to 10: 1 scope.Foregoing preservatives is benzoic acid, sodium benzoate, sorbic acid, sodium sorbate or parabens, and consumption is the 0.01-0.5wt% of oral liquid total amount.Above-mentioned correctives is sweeting agent, sugar-free sweetener, inclusion agents, fat material or essence etc., and consumption is the 0.01%-75wt% of oral liquid total amount.
Positive progressive effect of the present invention is: the Chinese medicine composition of treatment cyclomastopathy of the present invention has the curative effect of its depressed liver-energy dispersing and QI regulating, removing obstruction for relieving pain at the pathogenic characteristic of stagnation of QI due to depression of the liver blood stasis type cyclomastopathy.The preparation of the Chinese medicine composition of treatment cyclomastopathy of the present invention has the taking convenience of carrying, quality controllable, eutherapeutic characteristics.
The specific embodiment
Mode below by embodiment further specifies the present invention, but does not therefore limit the present invention among the described embodiment.
The preparation of embodiment 1 capsule
Take by weighing Rhizoma Cyperi 667g, Rhizoma Chuanxiong 445g, Semen Citri Reticulatae 445g, Herba Centellae 2000g; Rhizoma Cyperi is added 6 times of water distillations 5 hours, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then; Above-mentioned medical filtration gets filtrate A; Medicinal residues add 5 times of decoctings and boiled 1.5 hours, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.10 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 12 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, for the second time add 5 times of ethanol, extracted 2 hours at every turn, filter afterwards, filtrate recycling ethanol, filtrate D, the thick paste J that it is 1.30-1.32 that merging filtrate C and filtrate D, the liquor C after the merging and filtrate D concentrating under reduced pressure become 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With Herba Centellae extracting in water three times; Add for the first time 10 times of boiling water, second, add 8 times of water for three times respectively, the each decoction 1.5 hours filtered respectively and merging filtrate, and it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, adding ethanol afterwards is 60% to containing the alcohol amount, standing over night is filtered filtrate recycling ethanol, it is the thick paste I of 0.16-1.10 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, and first concentration with 3 times of resin bed volumes is 0.2% NaOH solution flushing, extremely neutral with the purified water flushing then, with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes again, the eluent concentrating under reduced pressure becomes thick paste, drying, dried cream powder are broken into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add the lactose of 1 times of weight of dried cream powder, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate, and mixing incapsulates 1000.
The specification of the capsule that makes is: the 0.3g/ grain.Usage and dosage is: oral, one time 3,3 times on the one.
The preparation of embodiment 2 capsules
Take by weighing Rhizoma Cyperi 334g, Rhizoma Chuanxiong 667g, Semen Citri Reticulatae 667g, Herba Centellae 2445g; Rhizoma Cyperi is added 7 times of water distillations 6 hours, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then; Above-mentioned medical filtration gets filtrate A; Medicinal residues add 6 times of decoctings and boiled 2 hours, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.12 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 14 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, for the second time add 5 times of ethanol, extracted 2 hours at every turn, filter afterwards, filtrate recycling ethanol, filtrate D, the thick paste J that it is 1.30-1.32 that merging filtrate C and filtrate D, the liquor C after the merging and filtrate D concentrating under reduced pressure become 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With Herba Centellae extracting in water three times; Add for the first time 10 times of boiling water, second, add 8 times of water for three times respectively, the each decoction 1.5 hours, filter respectively and merging filtrate, it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, adding 85% ethanol afterwards is 60% to containing the alcohol amount, standing over night is filtered filtrate recycling ethanol, it is the thick paste I of 0.16-1.10 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, and first concentration with 3 times of resin bed volumes is 0.2% NaOH solution flushing, extremely neutral with the purified water flushing then, with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes again, the eluent concentrating under reduced pressure becomes thick paste, drying, dried cream powder are broken into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add the starch of 10 times of weight of dried cream powder, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate, and mixing incapsulates 1000.
The specification of the capsule that makes is: the 0.3g/ grain.Usage and dosage is: oral, one time 3,3 times on the one.
The preparation of embodiment 3 capsules
Take by weighing Rhizoma Cyperi 889g, Rhizoma Chuanxiong 334g, Semen Citri Reticulatae 334g, Herba Centellae 1667g; Rhizoma Cyperi is added 5 times of water distillations 4 hours, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then; Above-mentioned medical filtration gets filtrate A; Medicinal residues add 4 times of decoctings and boiled 1 hour, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.10 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 14 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, for the second time add 5 times of ethanol, extracted 2 hours at every turn, filter afterwards, filtrate recycling ethanol, filtrate D, the thick paste J that it is 1.30-1.32 that merging filtrate C and filtrate D, the liquor C after the merging and filtrate D concentrating under reduced pressure become 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With Herba Centellae extracting in water three times; Add for the first time 10 times of water, second, add 8 times of water for three times respectively, the each decoction 1.5 hours, filter respectively and merging filtrate, it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, adding 85% ethanol afterwards is 60% to containing the alcohol amount, standing over night, filter, it is the thick paste I of 0.16-1.10 that filtrate recycling ethanol, concentrating under reduced pressure become 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, is earlier 0.2% NaOH solution flushing with the concentration of 3 times of resin bed volumes, then with the purified water flushing to neutral, again with 60% ethanol elution, the eluent eluent concentrating under reduced pressure of collecting 3.5 times of resin bed volumes becomes thick paste, drying, and dried cream powder is broken into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add the dextrin of 5 times of weight of dried cream powder, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate, and mixing incapsulates 1000.
The specification of the capsule that makes is: the 0.3g/ grain.Usage and dosage is: oral, one time 3,3 times on the one.
The preparation of embodiment 4 capsules
Take by weighing Rhizoma Cyperi 1112g, Rhizoma Chuanxiong 223g, Semen Citri Reticulatae 223g, Herba Centellae 3334g; Rhizoma Cyperi is added 6 times of water distillations 5 hours, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then; Above-mentioned medical filtration gets filtrate A; Medicinal residues add 5 times of decoctings and boiled 1.5 hours, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.10 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 12 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, for the second time add 5 times of ethanol, extracted 2 hours at every turn, filter afterwards, filtrate recycling ethanol, filtrate D, the thick paste J that it is 1.30-1.32 that merging filtrate C and filtrate D, the liquor C after the merging and filtrate D concentrating under reduced pressure become 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With Herba Centellae extracting in water three times; Add for the first time 10 times of boiling water, second, add 8 times of water for three times respectively, the each decoction 1.5 hours, filter respectively and merging filtrate, it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, the ethanol of Jia Ruing is 60% to containing the alcohol amount afterwards, standing over night is filtered filtrate recycling ethanol, it is the thick paste I of 0.16-1.10 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, and first concentration with 3 times of resin bed volumes is 0.2% NaOH solution flushing, extremely neutral with the purified water flushing then, with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes again, the eluent concentrating under reduced pressure becomes thick paste, drying, dried cream powder are broken into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add the mannitol of 3 times of weight of dried cream powder, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate, and mixing incapsulates, promptly.
The preparation of embodiment 5 capsules
Take by weighing Rhizoma Cyperi 445g, Rhizoma Chuanxiong 889g, Semen Citri Reticulatae 889g, Herba Centellae 1112g; Rhizoma Cyperi is added 6 times of water distillations 5 hours, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then; Above-mentioned medical filtration gets filtrate A; Medicinal residues add 5 times of decoctings and boiled 1.5 hours, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.11 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 13 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, for the second time add 5 times of ethanol, extracted 2 hours at every turn, filter afterwards, filtrate recycling ethanol, filtrate D, the thick paste J that it is 1.30-1.32 that merging filtrate C and D, the liquor C after the merging and D concentrating under reduced pressure become 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With Herba Centellae extracting in water three times; Add for the first time 10 times of water, second, add 8 times of water for three times respectively, the each decoction 1.5 hours filtered respectively and merging filtrate, and it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, the ethanol of Jia Ruing is 60% to containing the alcohol amount afterwards, standing over night is filtered filtrate recycling ethanol, it is the thick paste I of 0.16-1.10 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, and first concentration with 3 times of resin bed volumes is 0.2% NaOH solution flushing, extremely neutral with the purified water flushing then, with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes again, the eluent concentrating under reduced pressure becomes thick paste, drying, dried cream powder are broken into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add the lactose of 8 times of weight of dried cream powder, drying adds nutgrass galingale oil-beta cyclodextrin clathrate, and mixing incapsulates 1000.
The specification of the capsule that makes is: the 0.3g/ grain.Usage and dosage is: oral, one time 3,3 times on the one.
The preparation of embodiment 6 granules
Prescription by embodiment 1 takes by weighing four flavors; Rhizoma Cyperi is added 6 times of water distillations 5 hours, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then; Above-mentioned medical filtration gets filtrate A; Medicinal residues add 5 times of decoctings and boiled 1.5 hours, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.10 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 12 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, for the second time add 5 times of ethanol, extracted 2 hours at every turn, filter afterwards, filtrate recycling ethanol, get filtrate D, merging filtrate C and filtrate D, the thick paste J that it is 1.30-1.32 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With Herba Centellae extracting in water three times; Add for the first time 10 times of boiling water, second, add 8 times of water for three times respectively, the each decoction 1.5 hours, filter respectively and merging filtrate, it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and the ethanol of Jia Ruing is 60% to containing that alcohol measures afterwards, standing over night, filter, it is the thick paste I of 0.16-1.10 that filtrate recycling ethanol, concentrating under reduced pressure become 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, is earlier 0.2% NaOH solution flushing with the concentration of 3 times of resin bed volumes, then with the purified water flushing to neutral, again with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes, be evaporated to driedly, be ground into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add the starch of 6 times of weight of dried cream powder, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate, and mixing is used the compositing aluminium bag packing, makes 2000g.
The specification of the granule that makes is: the 6g/ bag.Usage and dosage is: oral, one time 1 bag, 3 times on the one.
The preparation of embodiment 7 tablets
Prescription by embodiment 1 takes by weighing four flavors; Rhizoma Cyperi is added 6 times of water distillations 5 hours, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then; Above-mentioned medical filtration gets filtrate A; Medicinal residues add 5 times of decoctings and boiled 1.5 hours, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.10 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 12 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, for the second time add 5 times of ethanol, extracted 2 hours at every turn, filter afterwards, filtrate recycling ethanol, get filtrate D, merging filtrate C and filtrate D, the thick paste J that it is 1.30-1.32 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, vacuum drying is ground into fine powder E; With Herba Centellae extracting in water three times; Add for the first time 10 times of boiling water, second and third time adds 8 times of water respectively, the each decoction 1.5 hours, filter respectively and merging filtrate, it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding 85% ethanol afterwards is 60% to containing the alcohol amount, standing over night, filter, it is the thick paste I of 0.16-1.10 that filtrate recycling ethanol, concentrating under reduced pressure become 60 ℃ of following relative densities; Filter, filtrate is by the D101 macroporous adsorbent resin, and first concentration with 3 times of resin bed volumes is 0.2% NaOH solution flushing, extremely neutral with the purified water flushing then, again with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes, be evaporated to driedly, be ground into fine powder F; Fine powder E and fine powder F are mixed into dried cream powder, add the mannitol of 2 times of weight of dried cream powder, make granule, drying adds nutgrass galingale oil-beta cyclodextrin clathrate, mixing, and tabletting, packing behind slice, thin piece packing or the bag film-coat is made 1000.
The specification of the granule that makes is: the 0.3g/ sheet.Usage and dosage is: oral, one time 3,3 times on the one.
The preparation of embodiment 8 oral liquids
Prescription by embodiment 1 takes by weighing four flavors; Rhizoma Cyperi is added 6 times of water distillations 5 hours, and medical filtration gets filtrate A; Medicinal residues add 5 times of decoctings and boiled 1.5 hours, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is 1.10 extractum G that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 12 hours, and C filters to get filtrate; The alcohol heating reflux of Rhizoma Chuanxiong and Semen Citri Reticulatae adding 85% is extracted twice, add for the first time 6 times of ethanol, add for the second time 5 times of ethanol, the each extraction 2 hours, filter afterwards, filtrate recycling ethanol gets filtrate D, merging filtrate C and filtrate D, the thick paste J that it is 1.30-1.32 that concentrating under reduced pressure becomes 60 ℃ of following relative densities; With Herba Centellae extracting in water three times; Add for the first time 10 times of boiling water, second and third time adds 8 times of water respectively, the each decoction 1.5 hours, filter respectively and merging filtrate, it is 1.05 extractum H that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding 85% ethanol afterwards is 60% to containing the alcohol amount, standing over night, filter, it is the thick paste I of 0.16-1.10 that filtrate recycling ethanol, concentrating under reduced pressure become 60 ℃ of following relative densities; Mix thick paste J and thick paste I, thin up adds 100g sodium benzoate and 100g essence again, supplies full dose 10000ml with water and makes oral liquid.Wherein, described antiseptic also can be selected other antiseptic commonly used for use, and as benzoic acid, sorbic acid, sodium sorbate or parabens etc., consumption is the 0.01%-75wt% of oral liquid total amount; Described correctives also can be selected other correctivess commonly used for use, and as sweeting agent, sugar-free sweetener, inclusion agents or fat material, consumption is the 0.01%-75wt% of oral liquid total amount.
The specification of the oral liquid that makes is: the 10ml/ bottle.Usage and dosage is: oral, one time 1 bottle, 3 times on the one.
Effect embodiment
The present invention is directed to the pathogenic characteristic of stagnation of QI due to depression of the liver blood stasis type cyclomastopathy, according to its depressed liver-energy dispersing and QI regulating, removing obstruction for relieving pain method of treatment and prescription, the meaning of imitative " danxi's experiential therapy " Yueju Wan legislation, regulate the flow of vital energy, invigorate blood circulation, eliminating stagnation, all methods of pain relieving be parallel, hot, warm, bitter, cold all medicines are with executing, focus on regulating functional activities of qi, and " regulate the flow of vital energy and not blood trouble, blood stasis dispelling and just do not hinder ".Select Rhizoma Cyperi, Rhizoma Chuanxiong for use, with depressed liver-energy dispersing and QI regulating resolving depression, blood-activating and qi-promoting pain relieving, to control the witness of the stagnation of QI, blood stagnation; Add with the Semen Citri Reticulatae of promoting QI to circulate and dispersing the agglomeration of the pathogens pain relieving, the Herba Centellae of removing toxic substances and promoting subsidence of swelling, the side of being combined into.
Among the present invention, Rhizoma Cyperi acrid in the mouth, the little hardship of property, little sweet, flat, return Liver Channel, hot can loosing, perfume (or spice) can be scurried, little hardship can be fallen, little sweet energy and, property is flat and cold not hot, be the principal agent of Liver Channel edema caused by disorder of QI, hold concurrently logical 12, be good at dispersing the stagnated live-QI to relieve the stagnation of QI through edema caused by disorder of QI, regulating functional activities of qi has merit soothing the liver, regulating QI to relieve pain, is gynecological's product commonly used, be particularly useful for the disease such as distending pain of the breast, abdominal pain during menstruation due to the depression of liver-QI, so be monarch drug.Rhizoma Chuanxiong nature and flavor suffering, warm in nature, return the liver and gall warp, Xin Xianghang looses, and warm promoting blood circulation can blood circulation promoting and blood stasis dispelling and eliminating stagnation, again can activating QI to alleviate the depression and pain relieving, forefathers are called " the gas medicine in the blood ", and stagnation of QI person should it, based on, the card that is usually used in stagnation of QI and blood, merit with sensible QI and blood, blood-activating and qi-promoting pain relieving, normal and compatibilities such as Radix Bupleuri, Rhizoma Cyperi are to treat all diseases due to the stagnation of QI due to depression of the liver, so be ministerial drug.Semen Citri Reticulatae is the seed of Fructus Citri tangerinae, and bitter in the mouth is flat, returns Liver Channel, the promoting QI to circulate and dispersing the agglomeration of the pathogens pain relieving, and the cards such as pain caking that are usually used in all diseases in position that Liver Channel is crossed are as breast caking, painful and swollen testis, hernia etc.; Herba Centellae bitter in the mouth, suffering, cold in nature, return liver, spleen channel, removing toxic substances and promoting subsidence of swelling; Semen Citri Reticulatae, Herba Centellae two medicines can assist monarch drug, ministerial drug to strengthen the effect of depressed liver-energy dispersing and QI regulating removing obstruction for relieving pain on the one hand, and the hot fragrant warm-dryness syndrome that can help Rhizoma Cyperi (processed), Rhizoma Chuanxiong again cold in nature of Herba Centellae prevents the dry cloudy blood of consumption that excessively exhausts of Xin Wenxiang, so be adjuvant in addition.All medicines share, and regulate the flow of vital energy, invigorate blood circulation, eliminating stagnation, all methods of pain relieving are parallel, hot, temperature, bitter, cold all medicines be with executing, and focus on regulating functional activities of qi, make that stagnation of liver-QI can be separated, the stagnation of QI can be relaxed, pain must be ended, lump can disappear, and disease then rehabilitates.
The present invention extracts volatile oil and uses beta-cyclodextrin inclusion compound by Rhizoma Cyperi, increases stability, and extracting solution carries out purification process; Rhizoma Chuanxiong, Semen Citri Reticulatae main component mostly are fat-soluble, adopt alcohol extraction; Herba Centellae medical material consumption is big, but the drug effect of relevant composition is clear and definite, and the composition relevant with this system curative effect is mainly Herba Centellae total glycosides, therefore, extracts purification by macroporous resin, makes the effective ingredient enrichment.By middle trial production checking, each stable yield of each technical process as a result, material balance, quality controllable, prove this feasible process.
1. effect experiment
To hyperplasia of mammary gland model, blood stasis model and the analgesia of SD female rats and NIH female mice, the antiinflammatory influence of acute and chronic inflammation, research is observed it to the curing mammary gland hyperplasia effect, specifically asks for an interview table 1 by Chinese medicine composition of the present invention.Wherein, SD rat body weight 180-220g, NIH mice body weight 18-22g is the SPF level, derives from Guangdong Medical Lab Animal Center.The result shows: use estradiol benzoate (E2) and Progesterone (P) preparation rat mammary gland hypertrophy disease model, after modeling while or success, gavage Chinese medicinal composition capsules of the present invention, two tests show that all Chinese medicine composition of the present invention can significantly reduce the incidence rate of rat mammary gland hypertrophy disease due to estradiol (E2), the Progesterone (P), the degree that suppresses cyclomastopathy, reduce the E2 concentration in the serum, have the effect of prevention and treatment cyclomastopathy; And can obviously suppress the mice caused by dimethylbenzene xylene ear swelling, carrageenin causes rat paw edema and acetic acid causes increasing of mouse peritoneal capillary permeability; Swollen being formed with of rat granuloma obviously there is inhibitory action, has the effect of anti-acute exudative inflammation and chronic nonspecific inflammation, but the pain that hot plate method and acetic acid cause is not had significant analgesia role; Experiment shows further that also Chinese medicine composition of the present invention also can reduce different shear rate whole blood viscosity of rat blood stasis model and plasma viscosity, blood viscosity lowering, improve blood stasis after hemorheology unusual.
Table 1: main pharmacodynamics experimental technique and result
Wherein, dosage is meant the amount that is converted to every kg body weight crude drug that experimental mouse gives; Onset dosage is meant and is converted to the dosage that crude drug that every kg body weight experimental mouse given produces curative effect; Be meant the multiple that is converted to human clinical's consumption by onset dosage with the relation of clinical plan consumption.
2. acute toxicity testing
Use 40 of NIH mices, the SPF level, male and female half and half, body weight 18-22g is provided by Guangdong Medical Lab Animal Center, carries out acute toxicity testing.Mice is divided into two groups at random, be matched group and administration group, fasting 12 hours before the experiment, (concentration is 5.76g crude drug/ml to give the Chinese medicinal composition capsules suspension of the invention described above then, maximum concentration) irritates stomach, irritate the stomach volume and be 40ml/kg (be that single-dose dosage is that the 230.4g crude drug/kg), matched group gives the equivalent normal saline, administration in 1 day 2 times, delivery time 6 hours, observed 14 days continuously after the administration, and toxic reaction and the death toll of record mice, specifically see table 2 for details.Experimental result shows: with matched group relatively, mice does not see notable difference after the administration, experiment was observed 14 days continuously, the mice overall health of patients, ingest, drinking-water, body weight gain is all normal.Mice oral administration gavage capsule LD of the present invention
50＞230.4g crude drug/kg, every day, maximum dosage-feeding was 460.8g crude drug/kg/ day.Chinese medicine composition clinical application amount of the present invention is 32g crude drug/day/people, becomes body weight for humans in 60kg, and average dosage is 0.533g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 20g) oral administration gavage Chinese medicine composition of the present invention is 864 times of clinical consumption.Therefore Chinese medicine composition acute toxicity of the present invention is low, clinical drug safety.
Table 2: the The acute toxicity tests of mice oral administration gavage Chinese medicinal composition capsules of the present invention
3. long term toxicity test
Select 132 of female sd inbred rats for use, SPF level, body weight 80～100g, provide by Guangdong Medical Lab Animal Center, be divided into 4 groups at random by body weight, promptly matched group, the basic, normal, high dosage group of Chinese medicine composition of the present invention (6.4,19.2,57.6g crude drug/kg), 33 every group.The administration group is subjected to reagent once every day, successive administration 3 months, 6 months and put to death each 11 of matched groups, basic, normal, high dosage group rat, totally 44 after convalescent period (drug withdrawal 1 month) respectively.Duration of test is observed outward appearance, general behavior, body weight change, the amount of drinking water of ingesting of animal, and 3,6 months and 1 month (convalescent period) of drug withdrawal are carried out index inspections such as hematology's (RBC, HCT, MCV, MCH, MCHC, HB, PLT, CT, WBC and classification, reticulocyte, clotting time etc.) and serum biochemistry (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, GLOB, A/G, TG, CHOL etc.), organ coefficient, histopathology after the administration.Result of the test shows: each treated animal general state is good, all no abnormal variation of outward appearance sign, behavioral activity, body weight gain; Three dosage groups and matched group are learned and are checked all in normal range not have significant difference between group at administration 3,6 months and drug withdrawal hematological examination after 1 month, blood biochemical; Each is organized main organs and organizes and do not see that pathology relevant with medicine change.This test dosage is respectively 12,36,108 times of clinical medicine dose, show according to result of the test: basic, normal, high three dosage of Chinese medicine composition of the present invention (6.4,19.2, the 57.6g crude drug/kg) administration in continuous 3,6 months does not have obvious influence to rat, no clear and definite toxicity target organ and sensitive indicator, convalescent period observes and does not also see the retardance toxic reaction, therefore the long term toxicity of Chinese medicine composition of the present invention is low, the dosage safety height of clinical practice.
Claims (13)
1. a Chinese medicine composition for the treatment of cyclomastopathy is characterized in that, described Chinese medicine composition is made by four flavor raw materials of following portions by weight: Rhizoma Cyperi 3～10, Rhizoma Chuanxiong 2～8, Semen Citri Reticulatae 2～8, Herba Centellae 10～30.
2. Chinese medicine composition as claimed in claim 1 is characterized in that, described Chinese medicine composition is made by four flavor raw materials of following portions by weight: Rhizoma Cyperi 4～8, Rhizoma Chuanxiong 3～6, Semen Citri Reticulatae 3～6, Herba Centellae 15～22.
3. Chinese medicine composition as claimed in claim 2 is characterized in that, described Chinese medicine composition is made by four flavor raw materials of following portions by weight: Rhizoma Cyperi 6, Rhizoma Chuanxiong 4, Semen Citri Reticulatae 4, Herba Centellae 18.
4. as each described Chinese medicine composition of claim 1～3, it is characterized in that the dosage form of described Chinese medicine composition is tablet, granule, capsule or oral liquid.
5. Chinese medicine composition as claimed in claim 4 is characterized in that: the dosage form of described Chinese medicine composition is a capsule.
6. as the preparation method of each described Chinese medicine composition of claim 1～3, it is characterized in that, may further comprise the steps:
1. take by weighing Rhizoma Cyperi, Rhizoma Chuanxiong, Semen Citri Reticulatae, Herba Centellae by weight;
2. Rhizoma Cyperi is added 5～7 times of water distillations 4-6 hour, collect volatile oil, with this volatile oil of beta-cyclodextrin inclusion compound, the nutgrass galingale oil that generates behind the enclose-beta cyclodextrin inclusion is standby then, and the medical filtration after the above-mentioned distillation gets filtrate A; Medicinal residues add 4-6 times of decocting and boiled 1-2 hour, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is the extractum of 1.10-1.12 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 10-14 hour, and C filters to get filtrate;
3. the alcohol heating reflux with Rhizoma Chuanxiong and Semen Citri Reticulatae adding 50-95% extracts, and filters afterwards, and filtrate recycling ethanol gets filtrate D;
4. merging filtrate C and filtrate D, it is the thick paste of 1.30-1.32 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, vacuum drying is ground into fine powder;
5. with the Herba Centellae extracting in water, filter to get filtrate, it is 1.05 extractum that concentrating under reduced pressure becomes 60 ℃ of following relative densities, adding 85% ethanol afterwards is 60% to containing the alcohol amount, left standstill 10-14 hour, and filtered filtrate recycling ethanol, it is the thick paste of 0.16-1.10 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, filter, filtrate is by the D101 macroporous adsorbent resin, and first concentration with 3 times of resin bed volumes is 0.2% NaOH solution flushing, extremely neutral with the purified water flushing then, with 60% ethanol elution, collect the eluent of 3.5 times of resin bed volumes again, concentrating under reduced pressure becomes thick paste, drying, dried cream powder is broken into fine powder;
6. with step 4. and 5. the fine powder of gained be mixed into dried cream powder, add adjuvant, granulate, drying, add step 2. in standby nutgrass galingale oil-beta cyclodextrin inclusion, behind the mixing granule packed in the capsulae vacuus, promptly get capsule; Or granule compositing aluminium bag packing, promptly get granule; Or granule is repressed, packing promptly got plain sheet or Film coated tablets after the gained slice, thin piece directly carried out packing or coating.
7. as the preparation method of each described Chinese medicine composition of claim 1～3, it is characterized in that, may further comprise the steps:
1. take by weighing Rhizoma Cyperi, Rhizoma Chuanxiong, Semen Citri Reticulatae, Herba Centellae by weight;
2. Rhizoma Cyperi is added 5～7 times of water distillations 4-6 hour, medical filtration gets filtrate A; Medicinal residues add 4-6 times of decocting and boiled 1-2 hour, the B that filters to get filtrate, and merging filtrate A and liquor B afterwards, it is the extractum of 1.10-1.12 that concentrating under reduced pressure becomes 60 ℃ of following relative densities, and adding ethanol afterwards is 65% to containing the alcohol amount, leaves standstill 10-14 hour, and C filters to get filtrate;
3. the alcohol heating reflux with Rhizoma Chuanxiong and Semen Citri Reticulatae adding 50-95% extracts, and filters afterwards, and filtrate recycling ethanol gets filtrate D;
4. merging filtrate C and filtrate D, it is the thick paste of 1.30-1.32 that concentrating under reduced pressure becomes 60 ℃ of following relative densities;
5. with the Herba Centellae extracting in water, filter to get filtrate, it is 1.05 extractum that concentrating under reduced pressure becomes 60 ℃ of following relative densities, adding 85% ethanol afterwards is 60% to containing the alcohol amount, leaves standstill 10-14 hour, filters, it is the thick paste of 0.16-1.10 that filtrate recycling ethanol, concentrating under reduced pressure become 60 ℃ of following relative densities;
6. with 4. gained thick paste and 5. gained thick paste mixing of step of step, thin up adds antiseptic and correctives again, supplies full dose with water, promptly gets oral liquid.
8. the preparation method of Chinese medicine composition as claimed in claim 6 is characterized in that: step adds 85% alcohol heating reflux with Rhizoma Chuanxiong and Semen Citri Reticulatae in 3. and extracts twice; Add for the first time 6 times of ethanol, add 5 times of ethanol for the second time, extracted 2 hours at every turn.
9. the preparation method of Chinese medicine composition as claimed in claim 6 is characterized in that: step 5. in Herba Centellae extracting in water three times, filter the back merging filtrate respectively; For the first time add 10 times of water, second and third time adds 8 times of water respectively, decocts 1.5 hours at every turn.
10. the preparation method of Chinese medicine composition as claimed in claim 9 is characterized in that: step 5. in Herba Centellae for the first time extracting in water be to add boiling water.
11. the preparation method of Chinese medicine composition as claimed in claim 7 is characterized in that: step adds 85% alcohol heating reflux with Rhizoma Chuanxiong and Semen Citri Reticulatae in 3. and extracts twice; Add for the first time 6 times of ethanol, add 5 times of ethanol for the second time, extracted 2 hours at every turn.
12. the preparation method of Chinese medicine composition as claimed in claim 7 is characterized in that: step 5. in Herba Centellae extracting in water three times, filter the back merging filtrate respectively; For the first time add 10 times of water, second and third time adds 8 times of water respectively, decocts 1.5 hours at every turn.
13. the preparation method of Chinese medicine composition as claimed in claim 12 is characterized in that: step 5. in Herba Centellae for the first time extracting in water be to add boiling water.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2012032250A1 (en) * | 2010-09-09 | 2012-03-15 | Naturex | Method for preparing an extract of centella asiatica |
| CN103961547A (en) * | 2014-05-08 | 2014-08-06 | 罗英 | Externally-applied traditional Chinese medicinal preparation for treating liver-qi stagnation type mammary gland hyperplasia and nursing method |
| CN104645063A (en) * | 2015-03-23 | 2015-05-27 | 曹燕欣 | Pills for treating hyperplasia of mammary glands and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100420480C (en) * | 2004-06-01 | 2008-09-24 | 闫丽娟 | Pillows for mastosis, e.g., hyperplasia, tumours and other diseases |
| CN100371012C (en) * | 2004-06-17 | 2008-02-27 | 成都地奥制药集团有限公司 | Medicinal composition, and its preparing method and use |
| CN101254265A (en) * | 2008-04-21 | 2008-09-03 | 北京中科仁和科技有限公司 | Chinese medicinal composition for curing gland hyperplasia and method of preparing the same |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012032250A1 (en) * | 2010-09-09 | 2012-03-15 | Naturex | Method for preparing an extract of centella asiatica |
| FR2964570A1 (en) * | 2010-09-09 | 2012-03-16 | Burgundy | PROCESS FOR PREPARING AN EXTRACT OF CENTELLA ASIATICA |
| CN103961547A (en) * | 2014-05-08 | 2014-08-06 | 罗英 | Externally-applied traditional Chinese medicinal preparation for treating liver-qi stagnation type mammary gland hyperplasia and nursing method |
| CN104645063A (en) * | 2015-03-23 | 2015-05-27 | 曹燕欣 | Pills for treating hyperplasia of mammary glands and preparation method thereof |
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