CN102406790A - Traditional Chinese medicine capsule for treating hyperplasia of mammary glands and preparation method thereof - Google Patents
Traditional Chinese medicine capsule for treating hyperplasia of mammary glands and preparation method thereof Download PDFInfo
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- CN102406790A CN102406790A CN2011102028065A CN201110202806A CN102406790A CN 102406790 A CN102406790 A CN 102406790A CN 2011102028065 A CN2011102028065 A CN 2011102028065A CN 201110202806 A CN201110202806 A CN 201110202806A CN 102406790 A CN102406790 A CN 102406790A
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Abstract
The invention relates to a traditional Chinese medicine capsule for treating hyperplasia of mammary glands with breast lump and tender breast caused by stagnation of liver-qi and turbid phlegm and blood stagnation. The capsule takes Chinese herbal medicines such as Snakegourd Fruit, rhizoma cyperi, Radix Paeoniae Rubra, rhizoma arisaematis, pericarpium citri reticulatae viride, pericarpium citri reticulatae, Sculellaria barbata and wild chrysanthemum as the raw materials and adopts modern scientific process for preparation. The capsule is capable of soothing-liver and regulating qi, reducing phlegm and resolving masses, activating blood circulation and removing blood stasis, relieving bruises and pains, regulating the body's secretion and estrogen level, and addressing both the symptoms and root causes of hyperplasia of mammary glands. The capsule is a new Chinese herbal preparation with exact treatment effect, no obvious toxic and side effect, safety and reliability.
Description
Technical field:
The present invention relates to a kind of Chinese medicine breast safe capsule preparations of knot and preparation technology thereof who treats hyperplasia of mammary glands.
Background technology:
Cyclomastopathy is the modal obstinate cystic hyperplasia of breast of women, and its sickness rate accounts for the first place of mastopathy.Cyclomastopathy is also claimed mammary gland cystic mastopathy, chronic mastopathy, capsule property cyclomastopathy, mammary gland fiber sexually transmitted disease (STD) or cyst property breast epithelium hypertrophy disease etc., belongs to traditional Chinese medical science nodules of the breast category.Should be the trend that rises year by year by the disease sickness rate in the last few years, the age also more and more becomes younger.There is 70%～80% women that cyclomastopathy is in various degree all arranged according to investigations approximately, is more common in the 25--45 women in year.The traditional Chinese medical science think primary disease mainly be owing to Chong and Ren channel disorder, stagnation of liver-QI, suffer from a deficiency of the kidney, expectorant coagulates, qi stagnation blood stasis forms.Modern medicine study proves, cyclomastopathy, and its canceration rate reaches 8.8%-21.8%.Also do not have specific chemicals at present, the treatment cyclomastopathy Chinese medicine preparation that has gone on the market has certain curative effect, but ideal pharmaceutical preparation seldom.Therefore, patient's expectation has the new drug preparation of definite curative effect.
Motherland's medical science thinks, cyclomastopathy is because internal damage by the excessive seven emotions, disorder of emotion, and blockage of meridian or Chong and Ren channel disorder, so that depression of liver-QI lose in catharsis, give birth in the dysfunction of the spleen in transportation, stagnation of phlegm, and stagnation of QI expectorant gathers or qi depression to blood stasis, and is long-pending and due to the in bulk.Therefore, should put in poison to the ill, treating both the principal and secondary aspects of a disease just can be obtained definite curative effect.Fructus Trichosanthis is the fruit of cucurbitaceous plant Fructus Trichosanthis or trichosanthes rosthornii Harms, sweet in the mouth, and little hardship, cold in nature.Have clearing away heat and eliminating phlegm, relieving stuffiness of the chest by dispersing aggregation of pathogens is moisturized laxation, and soothing liver-QI is strongly fragrant, and suppressing the hyperactive liver is contrary, the knot expectorant that disappears, the carbuncle of loosing poison effect.Be used to treat breast side of body painful abdominal mass pain, laryngopharynx swelling and pain; The nodules of the breast acute mastitis.Pharmacological research shows that Fructus Trichosanthis has the effect of coronary artery dilator, coronary blood flow increasing, antiplatelet aggregative activity, and phlegm-dispelling functions, antibacterial action improves hypoxia-bearing capability, antitumor and anti-aging effects etc.
Rhizoma Cyperi is the dry rhizome of sedge dried tuber, and acrid in the mouth, little hardship, little sweet are flat.The resolving depression of regulating the flow of vital energy, the menstruction regulating and pain relieving effect.Be used for stagnation of QI due to depression of the liver, breast, the side of body, abdominal distention, distending pain of the breast etc.Compendium of Material Medica is recited as: " Directorate-General DG of disorder of QI, the chief commander of gynecological ", Rhizoma Cyperi fragrance is walked to scurry, promoting QI circulation for relieving depression, " the strongly fragrant removing blood stasis that looses, make spontaneous and hundred bodies of fresh blood with " (" Elementary Medicine book on Chinese herbal medicine ").Pharmacological research shows, to central nervous system's effect, and to the effect of cardiovascular system, estrogen-like effects, analgesic cooling, antiinflammatory, antibiotic, analgesia, hypotensive effect etc.
Radix Paeoniae Rubra is gone into Liver Channel, " master breaks diffusing, tonneau, specially goes into liver man blood system " and " promoting the circulation of blood then cold and heat is broken sluggish blood from only, and then numbness and hernia abdominal mass are from disappearing " (" Bencao Jingshu ").
Rhizoma Arisaematis has the effect of " broken hard long-pending, subduing inflammation " (" Kaibao Bencao ").Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae have functions such as soothing the liver dispelling the stagnated QI, eliminating stagnationization stagnate, drying dampness to eliminate phlegm (" Chinese pharmacopoeia version in 2010).Herba Scutellariae Barbatae, Flos Chrysanthemi Indici have heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, dispersing swelling and dissipating binds pain relieving effect (" Chinese pharmacopoeia version in 2010).
The present invention according to the theory of Chinese medical science prescription, uses the modern science and technology method according to the effect and the effect of cyclomastopathy etiology and pathogenesis and above-mentioned Chinese medicine; According to the activity of drug ingredients constitutive property, study from effective component extracting and preparation process thereof, process and have depressed liver-energy dispersing and QI regulating; Dissipating phlegm and resolving masses, the promoting blood circulation and stopping pain effect is to stagnation of QI due to depression of the liver; Lump in breast distending pain due to the expectorant blood coagulation stasis of blood, cyclomastopathy has the capsule of definite curative effect.
Summary of the invention:
The objective of the invention is to seek and solve a kind ofly has definite curative effect and little, the safe and reliable ideal new Chinese medicine preparation of toxic and side effects to cyclomastopathy.For the patient provides the more new drug of more options, to promote human health.
The present invention is through following scheme implementation
According to the traditional Chinese medical science principles of formulating prescriptions; With the Fructus Trichosanthis is monarch drug; With Rhizoma Cyperi, Radix Paeoniae Rubra, Rhizoma Arisaematis is ministerial drug, is that adjuvant drug is formed prescription with Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Herba Scutellariae Barbatae, Flos Chrysanthemi Indici, adopts modern scientific method; Carry out extracts active ingredients, clarification, separation and purification, extracting solution vacuum concentration, drying process, add that proper auxiliary materials is mixed with the safe capsule preparations of breast knot.The formulation preparation technical step is following:
(1) getting Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae (being coarse powder), Flos Chrysanthemi Indici adds purified water and is dipped to medical material and runs through; Vapor distillation extracts volatile oil; Process clathrate by volatilize oil mass and beta-schardinger dextrin-1: 4-10 and 20-80 times of purified water of beta-schardinger dextrin-amount, drying, subsequent use;
(2) get the Herba Scutellariae Barbatae coarse powder and process alcohol extract;
(3) get the Radix Paeoniae Rubra coarse powder and process alcohol extract;
(4) Fructus Trichosanthis, Rhizoma Arisaematis (being coarse powder) are processed water extract or alcohol extract with medicinal residues such as Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici, Herba Scutellariae Barbatae, Radix Paeoniae Rubra;
(5) solution behind the said alcohol extract recovered alcohol and aqueous extract are carried out clarifying treatment, obtain clear filtrate;
(6) the clear filtrate vacuum concentration is become extractum, drying is pulverized, and with clathrate and an amount of pharmaceutic adjuvant mix homogeneously, processes hard capsule or extractum and volatile oil, the medication adjuvant is processed soft capsule.
The percentage by weight of above-mentioned raw materials medicine is Fructus Trichosanthis 15%-50%, Rhizoma Cyperi 18%-45%, Radix Paeoniae Rubra 6%-20%, Rhizoma Arisaematis 4%-15%, Pericarpium Citri Reticulatae Viride 2%-12%, Pericarpium Citri Reticulatae 3%-15%, Herba Scutellariae Barbatae 8%-30%, Flos Chrysanthemi Indici 10%-35%, and gross weight is 100%.
Alcohol extract is an ethanol extract in technical step of the present invention (2), (3), filters through 300 mesh sieves.
Technical step of the present invention (4) water extract filters through 300 mesh sieves.
Technical step of the present invention (5) removes impurity such as 75%-90% colloid, protein, phlegmatic temperament for the ZTC1+1 natural clarifying agent removes, and also can remove most of impurity with alcohol deposition method, obtains purity higher effective active matter.
The safe capsule pharmacological experiments of the present invention's breast knot shows, can obviously suppress the rat mammary gland hypertrophy that estradiol brings out, and obviously reduces the rat blood serum estradiol level, reduces uterus coefficient and ovary level, and prompting has the effect of the cyclomastopathy of inhibition; Can obviously suppress the rat paw edema that carrageenin brings out, improve mice hot plate pain territory etc., point out these article that anti-inflammatory and analgesic effect is arranged.
The present invention's breast knot is safe capsule toxicological study result show, acute toxicity, long term toxicity test all do not find to have tangible toxicity.
Pharmacology, toxicologic study result show, the safe capsule safety of the present invention's breast knot, effective.
The safe capsule for treating cyclomastopathy of the present invention's breast knot has definite curative effect.
The safe capsule for treating cyclomastopathy clinical observation on the therapeutic effect of embodiment breast knot
1, clinical data
(1) case selects to discuss calendar year 2001 with reference to " the clinical research guideline of Chinese new drug treatment cystic hyperplasia of breast ", Chinese Pharmaceutical Association surgery breast disease Professional Committee " cyclomastopathy diagnosis, dialectical and therapeutic evaluation standard ", the Chinese Chinese medicine industry standard " disease of tcm diagnosis criterion of therapeutical effect " of revision, and with the 90 routine cyclomastopathy patients group of doing experiment, matched group 30 examples are carried out clinical treatment observation; The test group age is less than 30 years old 27 examples, 38 examples in 31-40 year, 25 examples more than 41 years old; The matched group age is less than 30 years old 8 examples, 11 examples in 31-40 year, 11 examples more than 41 years old; 35.9 years old test group mean age (standard deviation 8.2 years old), 36.5 years old matched group mean age (standard deviation 8.0 years old), test group course of disease situation; The course of disease 1 year is with 58 interior examples, 16 examples in 1 year to 2 years, 12 examples in-three years more than 2 years; 4 examples more than 3 years, the matched group course of disease 1 year are with 20 interior examples, 6 examples in 1 year to 2 years; 3 examples in-three years more than 2 years, 1 example more than 3 years.Two groups of principal elements have harmony.
(2) the Therapeutic Method test group is taken the safe capsule of breast knot, each 4, every day 3 times.Matched group is taken the breast granule that disappears soon, each bag (10 gram), every day 3 times.3 months courses of treatment.Duration of test must not use the medicative Chinese medicine decoction of cyclomastopathy, Chinese patent medicine, Western medicine.
(3) observational technique clinical symptoms, tongue pulse condition, sign were all observed once in treatment in forward and backward 1,2,3 month; Ultrasound diagnosis must be before treatment, respectively carry out once in the week after the treatment menstruation in back 3 months; The molybdenum target inspection must be carried out once before treatment, treats and checks in case of necessity after three months; Routine blood test, routine urinalysis, stool routine examination, electrocardiogram, liver function, renal function must carry out one-time detection in forward and backward 3 months in treatment.
(4) efficacy assessment standard is discussed " cyclomastopathy diagnosis, dialectical and therapeutic evaluation standard ", " disease of tcm diagnosis criterion of therapeutical effect " (State Administration of Traditional Chinese Medicine's issue) of revision calendar year 2001 with reference to " the clinical research guideline of Chinese new drug treatment cystic hyperplasia of breast ", Chinese Pharmaceutical Association surgery breast disease Professional Committee.
The lump in breast size is comprehensively judged through auxiliary examinations such as palpation, molybdenum target X line, B ultrasonic or near infrared rays.
Clinical recovery: therapeutic index>=95%; Produce effects: 70%≤therapeutic index＜95%; Effectively: 30%≤therapeutic index＜70%; Invalid: therapeutic index＜30%.
(5) the statistical procedures data are analyzed with PP.
2, after result's 120 example treatments, the test group curative effect is superior to matched group, analyzes through PP, and two groups of total effectses are relatively seen table 1
Table 1 liang group total effects is (PP analysis) relatively
*Recovery from illness and produce effects P＜0.05
Clinical test results, test group recovery from illness and obvious effective rate 35.55%, total effective rate reaches 95.55%; Inefficiency 4.44%; Matched group obvious effective rate 16.67%, total effective rate 93.33% treatment group recovery from illness and produce effects and matched group relatively have significant difference, total effective rate difference not statistically significant.
3, safety inspection
Routine blood test, routine urinalysis, stool routine examination, liver function, renal function, electrocardiogram are all no abnormal.Explain that capsule of the present invention is safe and effective by clinical regulation medication.
The specific embodiment:
Below in conjunction with embodiment the present invention is done further elaboration.Following examples only are used to the purpose of giving an example and do not limit the present invention.
Embodiment one
Crude drug adopts Fructus Trichosanthis 282.5g Rhizoma Cyperi (system) 282.5g Radix Paeoniae Rubra 227.5g Rhizoma Arisaematis (system) 82.5g
Pericarpium Citri Reticulatae Viride 77.5g Pericarpium Citri Reticulatae 77.5g Herba Scutellariae Barbatae 177.5g Flos Chrysanthemi Indici 177.5g
Method for preparing
1, distillation extraction:
Get Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae and concoct qualifiedly respectively, be ground into coarse powder, with clean Flos Chrysanthemi Indici, add an amount of purified water and soaked 5 hours, put in the alembic, it is an amount of to add purified water, distill 7 hours, and the extraction volatile ingredient, subsequent use.
2, decoct extraction:
(1) get the Herba Scutellariae Barbatae coarse powder, use 75% alcohol reflux, get alcohol extract, filter with the 300-400 mesh sieve, subsequent use.
(2) get the Radix Paeoniae Rubra coarse powder, use 30% alcohol reflux, get alcohol extract, filter with the 300-400 mesh sieve, subsequent use.
(3) get medicinal residues such as Fructus Trichosanthis, Rhizoma Arisaematis medicinal material coarse powder and Radix Paeoniae Rubra, Herba Scutellariae Barbatae, Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici and put and add 12 times in water in the extraction pot and decoct 2 times, 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor; Vacuum concentration to medical material is 1 with the concentrated solution ratio: 6-10 ends, and takes advantage of heat to add the ZTC1+1 natural clarifying agent, leaves standstill 300 mesh sieve leaching supernatant; Filtrating is concentrated into the clear paste that relative density is 1.05-1.12 (80 ℃), puts and is chilled to room temperature, adds 95% ethanol and makes and contain alcohol amount and reach 60%; Stir hold over night, leaching ethanol clear liquid; Reclaim ethanol, medicinal liquid continues to be concentrated into the thick paste that relative density is 1.32-1.38 (60 ℃), and is subsequent use.
3, hard capsule preparation
(1) it is an amount of to get beta-schardinger dextrin-(by Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici distillation extraction thing amount 6 times), with 40 times of wiring solution-formings of hot purified water, under agitation adds Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici distillation extraction thing; Cold preservation is spent the night; The leaching deposition is drained vacuum dehydrating at lower temperature; Get clathrate, dry thing is pulverized subsequent use.
(2) get 2 thick paste vacuum dryings, dried cream powder is broken into fine powder, adds an amount of pharmaceutic adjuvant, and mix homogeneously is processed granule, drying, and granulate adds the volatile oil beta cyclodextrin inclusion complex fine powder, abundant mix homogeneously, filled capsules is processed 1000 altogether, promptly gets
4, soft capsule preparation
(1) after volatile oil adds the dilution of an amount of dehydrated alcohol and stirs, under agitation adds in 2 thick pastes, stir and made full and uniform, subsequent use in 1 hour.
(2) get gelatin and add an amount of purified water and make its swelling, dissolve into even gelatin solution, leave standstill, filter, put in the gelatin storage tank; Maintain the temperature at 50-65 ℃ of scope, the uniformity of adjustment rubber weight and rubber, the back pill that meets the requirements is with 4 (1) mixture fill system soft capsules; The soft capsule that fill becomes is inserted the dry rotating cage of rustless steel equably, and dryness finalization is evenly inserted in the frame dish again, dehumidifying, drying, and lamp inspection selects ball, polishing; Reject useless ball, packing is processed 1000 balls altogether after quality inspection is qualified, promptly gets.
Embodiment two
Crude drug adopts Fructus Trichosanthis 310.8g Rhizoma Cyperi (system) 310.8g Radix Paeoniae Rubra 250.3g Rhizoma Arisaematis (system) 90.8g
Pericarpium Citri Reticulatae Viride 85.3g Pericarpium Citri Reticulatae 85.3g Herba Scutellariae Barbatae 195.3g Flos Chrysanthemi Indici 195.3g
Method for preparing:
1, distillation extraction:
Get Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae and concoct qualifiedly respectively, be ground into coarse powder,, add an amount of purified water and soaked 4 hours for 4 times, put in the alembic, add 12 times of purified water of medical material amount with clean Flos Chrysanthemi Indici, distillation extraction 9 hours, volatile ingredient, subsequent use.
2, water extract-alcohol precipitation:
Fructus Trichosanthis, Radix Paeoniae Rubra, Rhizoma Arisaematis, Herba Scutellariae Barbatae coarse powder and Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, the Flos Chrysanthemi Indici medicinal residues of learning from else's experience the process of preparing Chinese medicine, purified treatment and pulverizing are put in the extraction pot, and add 15 times of water gagings and decoct 2 times, 2 hours for the first time, 1.5 hours for the second time; Twice decoction liquor merges, and filters with 300 mesh sieves, and filtrating vacuum concentration to medical material is 1: 1 o'clock with the concentrated solution ratio, stops to concentrate; Leave standstill to room temperature, add 95% ethanol, make to contain alcohol amount and reach 55%, stir; Hold over night, the leaching supernatant reclaims ethanol to there not being the alcohol flavor; Take advantage of heat to add the ZTC1+1 natural clarifying agent, stir, left standstill 4-10 hour; Supernatant is got in 300 sievings, is condensed into relative density and is the thick paste of 1.32-1.38 (60 ℃), and is subsequent use.
(1) hard capsule preparation
1. it is an amount of to get beta-schardinger dextrin-(by Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici distillation extraction thing amount 8 times), with 50 times of wiring solution-formings of hot purified water, under agitation adds Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici distillation extraction thing; Cold preservation is spent the night; Leaching deposition is taken out in, vacuum dehydrating at lower temperature; Get clathrate, dry thing is pulverized subsequent use.
2. get 2 thick pastes, vacuum drying, dried cream is pulverized with 80 mesh sieves, and comminuting matter and the 1. abundant mix homogeneously of fine powder add an amount of pharmaceutic adjuvant, and mix homogeneously is encapsulated, processes 1000 altogether, promptly gets.
(2) soft capsule preparation
1. get 1 volatile oil, add an amount of dehydrated alcohol dilution.Stir, subsequent use.
2. get 2 thick pastes, under agitation slowly add 1. mixed liquor, continue stirring and made full and uniform, subsequent use in 1 hour.
3. get gelatin and add an amount of purified water and make its swelling, dissolve into even gelatin solution, leave standstill, filter, put in the gelatin storage tank; Maintain the temperature at 50-65 ℃ of scope, note the uniformity of adjustment rubber weight and rubber, the back pill that meets the requirements, 2. mixture fill system soft capsule; The soft capsule that fill becomes is inserted the dry rotating cage of rustless steel equably, and dryness finalization is evenly inserted in the frame dish again, dehumidifying, drying, and lamp inspection selects ball, polishing; Reject useless ball, packing is processed 1000 balls altogether after quality inspection is qualified, promptly gets.
Embodiment three
Crude drug adopts Fructus Trichosanthis 268.4g Rhizoma Cyperi (system) 268.4g Radix Paeoniae Rubra 237.8g Rhizoma Arisaematis (system) 86.3g
Pericarpium Citri Reticulatae Viride 81.1g Pericarpium Citri Reticulatae 81.1g Herba Scutellariae Barbatae 185.5g Flos Chrysanthemi Indici 185.5g
Method for preparing:
1, distillation extraction: get Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae and concoct qualifiedly respectively, be ground into coarse powder,, add an amount of purified water and run through, put in the alembic with clean Flos Chrysanthemi Indici, water vapour distillation 9 hours, volatile ingredient, subsequent use.
2, decoct to extract: learn from else's experience and concoct qualified and be ground into the medicinal residues such as Fructus Trichosanthis, Radix Paeoniae Rubra, Rhizoma Arisaematis, Herba Scutellariae Barbatae and Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici of coarse powder, add water to extract 2 times for 10 times, 2 hours for the first time, 1.5 hours for the second time; Merge the water extract twice, filter, filtrating vacuum concentration to medical material is 1: 8 with the extracting solution ratio, takes advantage of heat to add the ZTC1+1 natural clarifying agent; Stirred 2 hours, and left standstill the leaching supernatant 6 hours; Half of vacuum concentration to filtrate volume takes advantage of heat to add an amount of ZTC1+1 natural clarifying agent again, leaves standstill after stirring 6 hours; The leaching supernatant, the sub-relative density of vacuum concentration is the thick paste of 1.32-1.38 (60 ℃), and is subsequent use.
3, alcohol extraction: 2 medicinal residues are added 8 times of amounts of 65% ethanol, and reflux, extract, twice 1.5 hours for the first time, adds 6 times of amounts of 60% ethanol for the second time; Extracted 1 hour, and merged alcohol extract twice, 300 mesh sieves filter; Filtrate recycling ethanol, concentrated solution take advantage of heat to add the ZTC1+1 natural clarifying agent, leave standstill after stirring 6 hours; Leaching supernatant, the sub-relative density of vacuum concentration are 1.35-1.40 (60 ℃), and be subsequent use.
4, formulation preparation:
(1) hard capsule preparation:
1. it is an amount of to get beta-schardinger dextrin-(by Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici distillation extraction thing amount 8 times), processes saturated beta-schardinger dextrin-solution in right amount with hot purified water, under agitation adds Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici distillation extraction thing; Cold preservation is spent the night; The leaching deposition is drained vacuum dehydrating at lower temperature; Get clathrate, dry thing is pulverized subsequent use.
2. get 2,3 thick paste mix homogeneously, vacuum drying, dried cream is pulverized with 80 mesh sieves, and comminuting matter and the 1. abundant mix homogeneously of fine powder add an amount of pharmaceutic adjuvant, and mix homogeneously is encapsulated, every 0.46-0.55 gram, packing promptly gets.
(2) soft capsule preparation
1. get 1 volatile oil, add an amount of dehydrated alcohol dilution.Stir, subsequent use.
2. get 2,3 thick paste mix homogeneously, under agitation add 1. mixed liquor, continue stirring and made full and uniform, subsequent use in 1 hour.
3. get gelatin and add an amount of purified water and make its swelling, dissolve into even gelatin solution, leave standstill, filter; Put in the gelatin storage tank, maintain the temperature at 5065 ℃ of scopes, note the uniformity of adjustment rubber weight and rubber, the back pill meets the requirements; 2. mixture fill system soft capsule is inserted the dry rotating cage of rustless steel equably with the soft capsule that fill becomes, and dryness finalization is evenly inserted in the frame dish again, dehumidifying, drying; Lamp inspection selects ball, polishing, rejects useless ball, and packing promptly gets after quality inspection is qualified.
The key technology of capsule of the present invention is capsule prescription and preparation process thereof.
The prepared capsule of the present invention has following characteristics:
1, the aqueous extraction-alcohol precipitation technology that Chinese crude drug is commonly used is because each active component different in kind of medical material, and the composition that is insoluble in water extracts not come out, and makes during precipitate with ethanol simultaneously to be insoluble in alcoholic acid effective ingredient deposition and to lose; Extracts active ingredients is incomplete, and the precipitate with ethanol removal of impurity is incomplete separately in addition, and extract purity is not high; Very big to the curative effect influence, extraction process of the present invention adopts medical material to merge or water or alcohol extraction or water, alcohol extraction respectively separately, and water-soluble or alcoholic acid effective ingredient is fully extracted; The active component extraction ratio is high; Particularly with ZTC1+1 natural clarifying agent clarification, impurity such as phlegmatic temperament, protein, the colloid etc. of removing no physiologically active reach 75%-90%, and effective ingredient such as polysaccharide, aminoacid, glycoside etc. can all remain; The effective site purity of extracting is high, and this is a common process advanced technologies can't be obtained.Common process: Fructus Trichosanthis, Radix Paeoniae Rubra, Rhizoma Arisaematis, Herba Scutellariae Barbatae (being coarse powder) and Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici extract medicinal residues behind the volatile oil, and it is that 1.05-1.10 (80 ℃) is put and is chilled to room temperature that extracting in water 2 times, water extract are concentrated into relative density; Adding ethanol makes the alcohol amount of containing reach 55%-70%; Staticly settle, the leaching supernatant reclaims ethanol; Solution continues to be concentrated into the thick paste that relative density is 1.35-1.40 (80 ℃), dry, pulverize subsequent use.With Hesperidin and peoniflorin extraction ratio is example, and the common process Hesperidin is 0.82%-1.10%, peoniflorin 0.55%-0.68%, the technology that the present invention adopts, and Hesperidin and peoniflorin are respectively 1.40%-1.75% and 0.90%-1.25%
2, because extraction process is advanced, the extract active constituent content is high, purity is high, prescription science, so capsule special effect; Treating both the principal and secondary aspects of a disease, evident in efficacy, function is wide, can regulate allomeric function, normal, the scalability hormonal readiness of endocrine regulation; Again can depressed liver-energy dispersing and QI regulating, dissipating phlegm and resolving masses, blood circulation promoting and blood stasis dispelling; Reducing swelling and alleviating pain has definite curative effect to all types of cyclomastopathies, mastalgia etc. clinically, and does not have obvious toxic-side effects.
Claims (2)
1. Chinese medicinal capsule agent of treating cyclomastopathy is characterized in that with Chinese crude drugs such as percentage by weight Fructus Trichosanthis 15%-50%, Rhizoma Cyperi 18%-45%, Radix Paeoniae Rubra 6%-20%, Rhizoma Arisaematis 4%-15%, Pericarpium Citri Reticulatae Viride 2%-12%, Pericarpium Citri Reticulatae 3%-15%, Herba Scutellariae Barbatae 8%-30%, Flos Chrysanthemi Indici 10%-35% be that crude drug is processed.
2. according to claims 1 described Chinese medicinal capsule agent, it is characterized in that its preparation technology is: (1) Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici water vapour distillation volatile oil and Fructus Trichosanthis, Radix Paeoniae Rubra, Rhizoma Arisaematis, Herba Scutellariae Barbatae and Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici medicinal residues are processed water, ethanol extract; (2) described extraction volatile oil is subsequent use or carry out enclose with its 3-10 beta-schardinger dextrin-aqueous solution doubly; (3) described water, ethanol extract, through concentrated, clarification, separation and purification, the refined solution vacuum concentration becomes thick paste or thick paste drying; (4) clathrate, the dried cream powder of gained is broken, behind an amount of pharmaceutic adjuvant mix homogeneously, process hard capsule or, process soft capsule volatile oil and thick paste mixture.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011102028065A CN102406790A (en) | 2011-07-14 | 2011-07-14 | Traditional Chinese medicine capsule for treating hyperplasia of mammary glands and preparation method thereof |
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| CN2011102028065A CN102406790A (en) | 2011-07-14 | 2011-07-14 | Traditional Chinese medicine capsule for treating hyperplasia of mammary glands and preparation method thereof |
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| CN102406790A true CN102406790A (en) | 2012-04-11 |
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| CN2011102028065A Pending CN102406790A (en) | 2011-07-14 | 2011-07-14 | Traditional Chinese medicine capsule for treating hyperplasia of mammary glands and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110731994A (en) * | 2019-11-15 | 2020-01-31 | 广西昌弘制药有限公司 | A Chinese medicinal preparation for treating mammary gland hyperplasia, and its preparation method |
| CN112807365A (en) * | 2019-11-15 | 2021-05-18 | 广西昌弘制药有限公司 | Traditional Chinese medicine preparation for treating hyperplasia of mammary glands and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1429596A (en) * | 2002-01-21 | 2003-07-16 | 阙锋 | Manufacturing process of Rujietai preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1429596A (en) * | 2002-01-21 | 2003-07-16 | 阙锋 | Manufacturing process of Rujietai preparation |
Non-Patent Citations (2)
| Title |
|---|
| 李朝兴: "新一代纯天然澄清剂ZTC系列天然澄清剂", 《离子交换与吸附》 * |
| 陈建功等: "中医药治疗乳腺增生病概况", 《中医杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110731994A (en) * | 2019-11-15 | 2020-01-31 | 广西昌弘制药有限公司 | A Chinese medicinal preparation for treating mammary gland hyperplasia, and its preparation method |
| CN112807365A (en) * | 2019-11-15 | 2021-05-18 | 广西昌弘制药有限公司 | Traditional Chinese medicine preparation for treating hyperplasia of mammary glands and preparation method thereof |
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Application publication date: 20120411 |