CN1966046A - Medicament for treating hyperplasia of mammary gland and preparation process thereof - Google Patents
Medicament for treating hyperplasia of mammary gland and preparation process thereof Download PDFInfo
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Abstract
Disclosed is a Chinese medicament for treating mammary gland hyperplasia and its preparation, wherein the medicament is prepared from the following raw materials (by weight portions): epimedium 95-150 parts, curculigo rhizome 95-150 parts, bupleurum root 55-85 parts, nutgrass flatsedge rhizome 55-85 parts, selfheal 95-150 parts, Chinese angelica root 95-150 parts, corydalis tuber 75-115 parts, toosendan fruit 75-115 parts, zedoary 75-115 parts and Sparganiaceae 75-115 parts. The preparing process consists of preparing volatile oil inclusion compound, water concentration liquid and medicinal dross from curcuma zedoaria rose, making clear grease, obtaining powders through spray-drying, subjecting the spray-dried powder and rhizoma zedoariae volatile oil inclusion compound and adjuvant to sieving, mixing uniformly and preparing medicinal powder, employing conventional method to obtain tablets, granules or capsules.
Description
Technical field: the invention belongs to the Chinese medicine preparation technical field, relate to a kind of medicine for the treatment of cyclomastopathy and preparation method thereof.
Technical background: cyclomastopathy is the modal mastopathy of the women of child-bearing age, is principal character with newborn pain and lump, and its sickness rate accounts for the women of child-bearing age's 40%, accounts for 70～80% of mastopathy.At present, modern medicine does not still have the definite effective Therapeutic Method to this disease, though reported successively since the eighties that treating its effective percentage of cyclomastopathy with tamoxifen can reach 86.00%, has report to there is bigger side effect yet, and easily outbreak repeatedly.But, have a large amount of clinical experimental research to show, its effective percentage of employing Chinese medicine cyclomastopathy can be up to more than 90%, determined curative effect.According to data, cyclomastopathy is classified by TCM Syndrome Type: caused by hepatic stagnation qi stagnation accounts for 31.11%, and Chong and Ren channel disorder type accounts for 29.44%, and expectorant stasis of blood condensation type accounts for 12.22%, and the deficiency of the liver and kindey type accounts for 10.28%, and QIXUELIANGXU type accounts for 16.95%.Wherein the adenosis of breast type accounts for more than 40%, and Chinese medical discrimination is then maximum with Chong and Ren channel disorder type, is caused by hepatic stagnation qi stagnation secondly.As seen Chong and Ren channel disorder shared ratio in mastopathy is most, and caused by hepatic stagnation qi stagnation is many with the mastalgia type.Be used for the treatment of at present nearly 9 kinds of the Chinese patent medicine of cyclomastopathy clinically, comprise the peaceful granule of breast, RUKUAIXIAO capsule, breast knot health ball, RUZENGNING PIAN, RUPIXIAO capsule, the peaceful sheet of breast, RUKANG PIAN, RUHE SANJIE PIAN, newborn disease spirit granule.This wherein is occupy 7 kinds of main effect with dispersing the stagnated live-QI to relieve the stagnation of QI, and with Chong and Ren Meridians regulating be main effect only have RUZENGNING PIAN a kind of, the visible latter's types of drugs wretched insufficiency.In addition, in above-mentioned 9 kinds of medicines, have 5 kinds to be that all the other 4 kinds is ministry standard by the new drug of Ministry of Public Health, National Drug Administration's approval, as seen the medicine of this class is less relatively, and the market development space is bigger.
Summary of the invention: the objective of the invention is at the problems referred to above, excavate motherland's medical treasure-house, a kind of medicine for the treatment of cyclomastopathy and preparation method thereof is provided, it is major function that this medicine is equipped with dispersing the stagnated live-QI to relieve the stagnation of QI, regulating QI to relieve pain, blood circulation promoting and dispersing pathogen accumulation with Chong and Ren Meridians regulating, its giving consideration to both the incidental and fundamental, method of treatment is more reasonable, can be releasing cyclomastopathy slight illness and has given play to definite curative effect.
Technical solution of the present invention comprises:
A kind of treatment cyclomastopathy medicine is characterized in that it is made by following weight parts proportion raw material medicine: Herba Epimedii 95-150 part Rhizoma Curculiginis 95-150 part Radix Bupleuri 55-85 part Rhizoma Cyperi (processed with vinegar) 55-85 part Spica Prunellae 95-150 part Radix Angelicae Sinensis 95-150 part Rhizoma Corydalis (processed with vinegar) 75-115 part parch Fructus Toosendan 75-115 part temperature Rhizoma Curcumae 75-115 part vinegar system rhizoma sparganic 75-115 part.
A kind of preparation method of aforementioned therapies cyclomastopathy medicine is characterized in that finishing by following steps after the weighting raw materials by weight ratio:
(1) Rhizoma Curcumae is ground into granule, soaks, vapor distillation extract Rhizoma Curcumae volatile oil, aqueous extract filters, filtrate concentrates 60-70 ℃ of heat and surveys to relative density 1.0-1.10, the Rhizoma Curcumae water extracting liquid, the rest is the Rhizoma Curcumae medicinal residues;
(2) get beta-schardinger dextrin-and add water, heating makes dissolving, adjusts temperature and also keeps to 55-65 ℃, adds above-mentioned Rhizoma Curcumae volatile oil while stirring, and cold preservation is spent the night, sucking filtration, and sucking filtration thing vacuum drying is pulverized, and crosses sieve No. six, gets the Rhizoma Curcumae volatile oil clathrate;
(3) get other nine flavors medicine and soak extraction three times with above-mentioned Rhizoma Curcumae medicinal residues, filter, merging filtrate, add above-mentioned Rhizoma Curcumae water extracting liquid again, thin film concentration 60-70 ℃ heat is surveyed to relative density 1.0-1.20, adds ethanol to determining alcohol again and reaches 70%, filter, decompression filtrate recycling ethanol, 55-65 ℃ of heat is surveyed to relative density 1.10-1.20, gets clear paste;
(4), get spray drying powder with the clear paste spray drying;
(5) spray drying powder and Rhizoma Curcumae volatile oil clathrate are sieved with adjuvant micropowder silica gel, magnesium stearate, mix medicated powder, make clinically according to conventional method then or acceptable dosage form pharmaceutically: a kind of in tablet, capsule, the granule.
Pharmacodynamic experiment result of the present invention shows:
(1) 7g/kg, 14g/kg, three dosage group preventions of 28g/kg administration can obviously alleviate the hypertrophy by estradiol induced mice mammary gland tissue, relatively have significant difference (P＜0.05) with model group.Mainly show as: can alleviate outgrowth mammary gland acinus and ductal ectasia degree, reduce secreting phenomenon, wherein with in, heavy dose of group effect is obvious.
(2) 3.5g/kg, 7g/kg, three dosage group treatments of 14g/kg administration can obviously alleviate the hypertrophy by rat mammary gland tissue due to estradiol and the progesterone.Mainly show as: 1. can obviously reduce the rat blood serum estradiol and the rising progesterone levels is recovered unbalance estrogen level; 2. can obviously raise serum activity of SOD, reduce the content of MDA, have antioxidation; 3. can obviously reduce the height of nipples of rat, and can reduce outgrowth mammary gland acinus volume, alleviate the ductal ectasia degree, reduce secreting phenomenon, and increase with dosage, effect is more obvious.Each index and model group relatively have significant difference (P＜0.05,0.01).
(3) 7g/kg, 14g/kg, three dosage groups of 28g/kg are to having the improvement effect by epinephrine induced mice auricular microcirculation obstacle, mainly show as: the mice blood capillary arteriole of contraction, thin vein caliber are increased, relatively have significant difference (P＜0.05,0.01) with the blank group.
(4) 3.5g/kg, 7g/kg, three dosage groups of 14g/kg have some improvement to the hemorheology tool of the stasis syndrome card rat of being caused by " epinephrine+frozen water ".Mainly show as: can reduce whole blood viscosity, whole blood reduced viscosity (low cutting) and plasma viscosity, relatively have significant difference (P＜0.05,0.01) with model group.
(5) 7g/kg, 14g/kg, three dosage groups of 28g/kg can alleviate the mice pain reaction (writhing response) due to being stimulated by acetic acid and cause mice foot sole of the foot pain reaction by electricity irritation, with the blank group significant difference (P＜0.05,0.01) are arranged more all.
In sum, medicine of the present invention has tangible resisting hyperplasia of mammary glands, microcirculation improvement, improves effects such as hemorheology and analgesia.
Pharmacology toxicity test of the present invention:
(1) test of acute toxicity testing----maximum dosage-feeding.Experimental result shows: this medicine is by the mice of twice gastric infusion on the one, its maximum dosage-feeding is 480g/kg, as being that 42g/60kg calculates by clinical adult oral dose on the one, then the maximum dosage-feeding of the mice of this medicine filling on the one stomach is 686 times [(480g/kg)/(42g/60kg)] of clinical adult oral dose on the one, shows that this safety of medicine degree is bigger.
(2) long term toxicity test.With this medicine 10.5g/kg (crude drug amount, 15 times of clinical consumption), 21g/kg (crude drug amount, 30 times of clinical consumption), 42g/kg (crude drug amount, 60 times of clinical consumption) three dosage groups are given 24 weeks of rat oral gavage continuously and were recovered for 3 weeks, and three dosage groups of this medicine do not have obviously influence to the general situation of rat, body weight, food ration, hematology, blood biochemical, organ coefficient etc. as a result; Microscopic examination showed, this medicine is not seen tangible histology's pathological change to main organs such as rat heart, liver, spleen, lungs, kidney, stomach, brain, thyroid, thymus, adrenal gland, hypophysis, prostate, testis, epididymis, ovary, uterus, mammary gland yet.Show that this medicine does not have the toxic action of the property accumulated for a long time substantially to rat.
This pharmic function cures mainly: dispersing the stagnated live-QI to relieve the stagnation of QI, Chong and Ren Meridians regulating, regulating QI to relieve pain, blood circulation promoting and dispersing pathogen accumulation.Be used for the treatment of the caused cyclomastopathy disease of stagnation of QI due to depression of the liver.
The specific embodiment: the invention will be further described below in conjunction with embodiment.
Embodiment 1, medication preparation of the present invention.The crude drug prescription is pressed the weight proportion blanking of Herba Epimedii 95-150 part, Rhizoma Curculiginis 95-150 part, Radix Bupleuri 55-85 part, Rhizoma Cyperi (processed with vinegar) 55-85 part, Spica Prunellae 95-150 part, Radix Angelicae Sinensis 95-150 part, Rhizoma Corydalis (processed with vinegar) 75-115 part, parch Fructus Toosendan 75-115 part, warm Rhizoma Curcumae 75-115 part, vinegar system rhizoma sparganic 75-115 part; Prepare by following steps:
(1) Rhizoma Curcumae is ground into granule, soaks, vapor distillation extract Rhizoma Curcumae volatile oil, aqueous extract filters, filtrate concentrates 60-70 ℃ of heat and surveys to relative density 1.0-1.10, the Rhizoma Curcumae water extracting liquid, the rest is the Rhizoma Curcumae medicinal residues;
(2) get beta-schardinger dextrin-and add water, heating makes dissolving, adjusts temperature and also keeps to 55-65 ℃, adds above-mentioned Rhizoma Curcumae volatile oil while stirring, and cold preservation is spent the night, sucking filtration, and sucking filtration thing vacuum drying is pulverized, and crosses sieve No. six, gets the Rhizoma Curcumae volatile oil clathrate;
(3) get other nine flavors medicine and soak extraction three times with above-mentioned Rhizoma Curcumae medicinal residues, filter, merging filtrate, add above-mentioned Rhizoma Curcumae water extracting liquid again, thin film concentration 60-70 ℃ heat is surveyed to relative density 1.0-1.20, adds ethanol to determining alcohol again and reaches 70%, filter, decompression filtrate recycling ethanol, 55-65 ℃ of heat is surveyed to relative density 1.10-1.20, gets clear paste;
(4), get spray drying powder with the clear paste spray drying;
(5) spray drying powder and Rhizoma Curcumae volatile oil clathrate are sieved with adjuvant micropowder silica gel, magnesium stearate, mix medicated powder, make clinically according to conventional method then or acceptable dosage form pharmaceutically: a kind of in tablet, capsule, the granule.
Embodiment 2, optimization formula medication preparation of the present invention.Its crude drug prescription is pressed Herba Epimedii 113-125 part, Rhizoma Curculiginis 113-125 part, Radix Bupleuri 68-75 part, Rhizoma Cyperi (processed) 68-75 part, Spica Prunellae 113-125 part, Radix Angelicae Sinensis 113-125 part, Rhizoma Corydalis (processed with vinegar) 90-100 part, parch Fructus Toosendan 90-100 part, warm Rhizoma Curcumae 90-100 part, the blanking of vinegar system rhizoma sparganic 90-100 part weight proportion; Processing step by previous embodiment 1 prepares then.
Embodiment 3, capsule medicine preparation of the present invention.The crude drug prescription is pressed the proportioning blanking of Herba Epimedii 500g, Rhizoma Curculiginis 500g, Radix Bupleuri 300g, Rhizoma Cyperi (processed with vinegar) 300g, Spica Prunellae 500g, Radix Angelicae Sinensis 500g, Rhizoma Corydalis (processed with vinegar) 400g, parch Fructus Toosendan 400g, warm Rhizoma Curcumae 400g, vinegar system rhizoma sparganic 400g, then according to following processing step preparation:
(1) get the Rhizoma Curcumae medical material, be ground into granule, add 6 times of water gagings and soaked 0.5 hour, vapor distillation extracted 4 hours, and it is standby to get Rhizoma Curcumae volatile oil; Aqueous extract filters, and filtrate concentrates 65 ℃ of heat and surveys to relative density 1.05, and it is standby to get the Rhizoma Curcumae water extracting liquid; The Rhizoma Curcumae medicinal residues are standby with container package.
(2) get beta-schardinger dextrin-24g, add water 300ml, heating makes dissolving, adjusts temperature to 60 ℃ also maintenance, adds above-mentioned Rhizoma Curcumae volatile oil while stirring, per minute 1ml stirred 1 hour, and cold preservation is spent the night, sucking filtration, sucking filtration thing vacuum drying is pulverized, and crosses sieve No. six, and it is standby to get the Rhizoma Curcumae volatile oil clathrate.
(3) other nine flavors medicines of getting except that Rhizoma Curcumae add 9 times of amounts of water (V/W) with above-mentioned Rhizoma Curcumae medicinal residues, soak 1 hour; Extract three times with each 1.5 hours time then, wherein second and third time adds each 7 times of amount of water; Filter, merging filtrate adds above-mentioned Rhizoma Curcumae water extracting liquid again, 65 ℃ of heat of thin film concentration are surveyed to relative density 1.10, add ethanol to determining alcohol again and reach 70%, filter, 75 ℃ ,-condition of 0.08Mpa under decompression filtrate recycling ethanol, 60 ℃ of heat are surveyed to relative density 1.15, clear paste.
(4) with clear paste 180 ℃ of intake air temperatures, pressure 0.2MPa carries out spray drying under the condition that the air outlet temperature is 78 ℃, spray drying powder.
(5) spray drying powder and Rhizoma Curcumae volatile oil clathrate are crossed 80 mesh sieves with micropowder silica gel 100g, magnesium stearate 18g, granulate, and cross 30 mesh sieves and carry out granulate with granulator.
(6) get the fore shaft hard capsule No. 0, above-mentioned granule under the condition of RH≤50%, is pressed the granule 0.5Kg fill of per 1000 capsules.
Every of the capsule that adopts this method to make contains granule 0.5g, is equivalent to crude drug 3.5g.Oral consumption, a 3-4 grain, 3 times on the one.
Claims (4)
1, a kind of treatment cyclomastopathy medicine is characterized in that it is made by following weight parts proportion raw material medicine:
Herba Epimedii 95-150 part Rhizoma Curculiginis 95-150 part Radix Bupleuri 55-85 part Rhizoma Cyperi (processed with vinegar) 55-85 part Spica Prunellae 95-150 part Radix Angelicae Sinensis 95-150 part Rhizoma Corydalis (processed with vinegar) 75-115 part parch Fructus Toosendan 75-115 part temperature Rhizoma Curcumae 75-115 part vinegar system rhizoma sparganic 75-115 part.
2,, it is characterized in that the weight portion optimum ratio of described crude drug is according to the treatment cyclomastopathy medicine of claim 1:
Herba Epimedii 113-125 part Rhizoma Curculiginis 113-125 part Radix Bupleuri 68-75 part Rhizoma Cyperi (processed) 68-75 part Spica Prunellae 113-125 part Radix Angelicae Sinensis 113-125 part Rhizoma Corydalis (processed with vinegar) 90-100 part parch Fructus Toosendan 90-100 part temperature Rhizoma Curcumae 90-100 part vinegar system rhizoma sparganic 90-100 part
3, according to the treatment cyclomastopathy medicine of claim 1 or 2, it is characterized in that this medicine is made clinically or acceptable dosage form pharmaceutically: a kind of in tablet, capsule, the granule.
4,, it is characterized in that by finishing by following steps after the proportioning weight portion weighting raw materials according to the preparation method of claim 1 or 2 described treatment cyclomastopathy medicines:
(1) Rhizoma Curcumae is ground into granule, soaks, vapor distillation extract Rhizoma Curcumae volatile oil, aqueous extract filters, filtrate concentrates 60-70 ℃ of heat and surveys to relative density 1.0-1.10, the Rhizoma Curcumae water extracting liquid, the rest is the Rhizoma Curcumae medicinal residues;
(2) get beta-schardinger dextrin-and add water, heating makes dissolving, adjusts temperature and also keeps to 55-65 ℃, adds above-mentioned Rhizoma Curcumae volatile oil while stirring, and cold preservation is spent the night, sucking filtration, and sucking filtration thing vacuum drying is pulverized, and crosses sieve No. six, gets the Rhizoma Curcumae volatile oil clathrate;
(3) get other nine flavors medicine and soak extraction three times with above-mentioned Rhizoma Curcumae medicinal residues, filter, merging filtrate, add above-mentioned Rhizoma Curcumae water extracting liquid again, thin film concentration 60-70 ℃ heat is surveyed to relative density 1.0-1.20, adds ethanol to determining alcohol again and reaches 70%, filter, decompression filtrate recycling ethanol, 55-65 ℃ of heat is surveyed to relative density 1.10-1.20, gets clear paste;
(4), get spray drying powder with the clear paste spray drying;
(5) spray drying powder and Rhizoma Curcumae volatile oil clathrate are sieved with adjuvant micropowder silica gel, magnesium stearate, mix medicated powder, make clinically according to conventional method then or acceptable dosage form pharmaceutically: a kind of in tablet, capsule, the granule.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006101020135A CN100509050C (en) | 2006-10-12 | 2006-10-12 | Medicament for treating hyperplasia of mammary gland and preparation process thereof |
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| CNB2006101020135A CN100509050C (en) | 2006-10-12 | 2006-10-12 | Medicament for treating hyperplasia of mammary gland and preparation process thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102370948A (en) * | 2011-11-17 | 2012-03-14 | 中国中医科学院中医临床基础医学研究所 | Chinese medicinal compound preparation for treating hyperplasia of mammary glands and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102370948A (en) * | 2011-11-17 | 2012-03-14 | 中国中医科学院中医临床基础医学研究所 | Chinese medicinal compound preparation for treating hyperplasia of mammary glands and preparation method thereof |
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