CN100488525C - Medicine for treating female climacterium syndrome and its preparation method - Google Patents
Medicine for treating female climacterium syndrome and its preparation method Download PDFInfo
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- CN100488525C CN100488525C CNB2006100891251A CN200610089125A CN100488525C CN 100488525 C CN100488525 C CN 100488525C CN B2006100891251 A CNB2006100891251 A CN B2006100891251A CN 200610089125 A CN200610089125 A CN 200610089125A CN 100488525 C CN100488525 C CN 100488525C
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Abstract
A Chinese medicine in the form of tablet or capsule for treating the climacteric syndrome of woman, osteoporosis, and cardiovascular disease and improving immunity contains proportionally soybean isoflavone, extract of astragalus root, general saponin of gynostemma pentaphyllum, microcrystalline cellulose, cardoxymethyl starch sodium or low-substituted hydroxypropyl cellulose, and magnesium stearate. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to Chinese medicine preparation, be specifically related to a kind of to treat the Women disease, double Chinese medicine preparation and the manufacture method of controlling osteoporosis, cardiovascular diseases and improving immunity.
Background technology
With age, the aggravation of social competition, load-bearing in the family life in addition, women's health faces very big problem, for example usually occur that hectic fever is flushing, spontaneous sweating, vexed peaceful, insomnia and dreamful sleep, dizziness and tinnitus etc. are because of clinical symptoms that decrease in estrogen produced, and follow depressed, easy fatigue, immunocompromised and state such as absent minded, long-term symptom is osteoporosis, cardiovascular disease and senile dementia etc.These symptoms not only serious threat women's physical and mental health, influence quality of life, also society and family are brought harmful effect simultaneously.Still do not have the good curing method for above symptom doctor trained in Western medicine at present, the slight person of degree generally takes an amount of tranquillizer etc., can only alleviate, and cures the symptoms, not the disease; The serious symptom person then adopts controversies in hormone replacement in the elderly, but the side effect of this therapy is more, can cause discomforts such as metrorrhagia, mammary gland swelling, and the danger that increases breast carcinoma and onset of endometrial cancer is also arranged.Traditional in addition tcm prescription boils the process complexity and brings inconvenience to the patient, though this sick Chinese medicine preparation prescription of treatment was arranged in recent years, also has all deficiencies.
Publication number is CN 1401320, open day be that the Chinese patent application on March 12nd, 2003 discloses the patent of " a kind of treatment climacteric syndrome medicine ".The effective ingredient of this method is soybean isoflavone and wolfberry fruit extract, soybean isoflavone can play the effect of alleviating climacteric syndrome, effects such as the hot side that has a tidal wave of is red, spontaneous sweating, vexed peaceful, insomnia and dreamful sleep, dizziness and tinnitus, soreness of the waist and knees, feverish sensation in the palms and soles, but because effective ingredient is more single, do not contain the Radix Astragali etc. can defying age and improve body immunity composition, cause its curative effect also comparatively single.
Publication number is CN 1401351, open day be that the Chinese patent application on March 12nd, 2003 discloses the patent of " medicine of treatment climacteric syndrome ".This medicine is formulated in proportion by 13 flavor Chinese medicines such as Rhizoma Coptidis, Cortex Cinnamomi, Fructus Lycii, Fructus Corni.Composition is various, the preparation process relative complex, and price is more expensive.
Summary of the invention
Technical problem to be solved by this invention provides a kind of few female dimacteric syndrome that cures mainly evident in efficacy of that natural plant active component is formed, side reaction that adopts, double control osteoporosis, cardiovascular diseases, defying age and improve immunity compound Chinese medicinal preparation.
A kind of medicine for the treatment of female dimacteric syndrome, it is characterized in that, the composition that comprises following mass fraction: 2-5 parts of soybean isoflavones, 3.5-7 parts of Radix Astragali extracts, 1-3 parts of Herb Gynostemmae Pentaphylli total glycosidess, 4-8 parts of microcrystalline Cellulose, 0.5-1.5 parts of carboxymethyl starch sodium or low-substituted hydroxypropyl celluloses, 0.05-0.15 part of magnesium stearate.
Manufacture method of the present invention is: extraction-granulation-tabletting, finished dosage forms is a tablet during film-making.Concrete manufacturing process is as follows:
1, preparation extract
Soybean isoflavone: leaching process sees that application number is: 200510008536.9 patent application, please replacement demand day the application title, concrete leaching process is: (this patent applies for, but also unexposed, so there is not publication number)
(1) low temperature soy meal is pulverized, crossed 40～60 mesh sieves, get the low temperature soy meal powder;
(2) low temperature soy meal powder and extractant 50～90% ethanol waters carry out the continuous multi-stage countercurrent lixiviate under 45～85 ℃, the mass volume ratio of low temperature soy meal powder and extractant (kg/L) is 1:2～5, obtain the ethanol leaching liquid reduction vaporization of low temperature soy meal, remove ethanol, obtain the soybean isoflavone concentrated aqueous solution;
(3) adding calcium hydroxide in the soybean isoflavone concentrated aqueous solution of step (2), to regulate pH value be 8～12, flocculation, leave standstill remove flocculate precipitate after, regulate pH value to 6～7 with hydrochloric acid, flocculation, leave standstill remove flocculate after, obtain the material liquid that flocculates;
(4) with the ethyl acetate be extractant, the flocculation material liquid of step (3) is extracted that concentrating under reduced pressure is removed ethyl acetate, obtain purity and be about 40% the thick product of soybean isoflavone, extraction yield is more than 95%;
(5) the thick product of soybean isoflavone of step (4) carries out recrystallization with petroleum ether, and petroleum ether is 5～9:1 with the volume mass of the thick product of soybean isoflavone than (L/kg), can obtain the soybean isoflavone product of purity more than 95%.
Radix Astragali extract: get crude drug Radix Astragali decoction pieces, add 8-12 times of water gagings (mass fraction) and decoct 2 times, each 1-3 hours, decoction liquor was filtered the back and is merged, and gets Radix Astragali extractive solution; Radix Astragali extractive solution is abandoned behind the supernatant the residue concentrating under reduced pressure, and condition is: 70 ℃, vacuum-0.1MPa, to relative density be 1.05～1.10 (50 ℃), add 2-4 times of amounts (volume parts) ethanol and make precipitation, place, inclining supernatant; Precipitate adds 50 ℃-70 ℃ hot water dissolving, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 70%-75% (mass fraction), places, and inclining supernatant; Precipitate adds 50 ℃-70 ℃ hot water dissolving again, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 80%-85% (mass fraction), places, and inclining supernatant, extractum; Gained extractum is carried out spray drying, promptly get Radix Astragali extract.
2, granulate
Respectively supplementary material is crossed 80 mesh sieves, 2-5 parts of soybean isoflavones, 3.5-7 parts of Radix Astragali extracts, 1-3 parts of Herb Gynostemmae Pentaphylli extracts, 4-8 parts of microcrystalline Cellulose, 0.5-1.5 parts of 0.3-0.9 part of carboxymethyl starch sodium (in add) or low-substituted hydroxypropyl celluloses, mix homogeneously, it is an amount of to add 70% ethanol water, make soft material, cross the 12-18 mesh sieve and granulate, 12-18 mesh sieve granulate is crossed in 50 ℃ of forced air dryings.(being mass fraction)
3, tabletting
Add 0.05-0.15 part of 0.2-0.6 part of carboxymethyl starch sodium (adding), magnesium stearate in the dried granule, mix homogeneously, compressed tablets.(being mass fraction)
Semen sojae atricolor is the mature seed of legume soybean in the side, and Shennong's Herbal had been put down in writing Semen sojae atricolor and medical value thereof first in B.C. 2838, was listed as " middle product ", had the effect of building body, and women's chronic disease is had the prophylactic treatment effect.The Radix Astragali is leguminous plant, and is sweet in flavor and warm in property, returns lung, spleen channel.As Chinese medicine, have benefit and defend consolidating superficial resistance, inducing diuresis to remove edema, promoting pus discharge and tissue regeneration strengthening, invigorating the spleen and replenishing QI, relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, the sensible effect of lung qi dispersing; It is weak to be used for the deficiency of vital energy, anorexia and loose stool, and sinking of QI of middle-JIAO, the exterior deficiency spontaneous perspiration, deficiency of vital energy edema is burst for a long time and is not held back, blood deficiency and yellow complexion, interior-heat is quenched one's thirst.Herb Gynostemmae Pentaphylli is a cucurbitaceae genus gynostemma, the nature and flavor bitter cold.Has eliminating inflammation and expelling toxin, the effect of quenching the thirst and eliminating the phlegm.
Modern medicine study shows, soybean isoflavone is a class phytoestrogen, mainly contain two kinds of the former and genisteins of daiazi, its structure is similar to estrogen, soybean isoflavone to and hectic fever is flushing, spontaneous sweating, vexed not rather, insomnia and dreamful sleep, dizziness and tinnitus clinical symptoms all have improvement.Menopausal women is taken soybean isoflavone, and hormonal readiness arrives some in the blood, can improve climacteric women gonadal hormone and clinical symptoms, improves the immunologic function of human body.Astragalus polysaccharides is one of main active of the Radix Astragali, has remarkable enhancing human body immunity, anti-ageing multiple function and the pharmacological effect of waiting for a long time.There are 6 kinds of Saponins identical in the Herb Gynostemmae Pentaphylli, also have some can obtain the ginsenoside through hydrolysis with ginsenoside's structure.Gypenoside has many-sided effects such as strong, anoxia enduring, high temperature resistant, resisting fatigue, enhancing immunity to human body.These are highly profitable to motor capacity, promotion fatigue recovery, the adjustment functional status that improves human body.
Make a general survey of this side and be the compound recipe that a kinds of traditional Chinese medicines is formed, rigorous, all medicine of medicine share, brings out the best in each other, effect is remarkable owing to select.Start with from lung stomach, spleen kidney four dirty physiological characteristicies, based on treatment Woman climacteric disease,, strengthening vital QI to eliminate pathogenic factors the same to be in harmonious proportion is aim, possessed lung heat clearing stomach function regulating, invigorating spleen and kidney, alleviate the symptom of Woman climacteric, improve osteoporosis, the effect of enhancing human body immunity power.
In addition, prescription of the present invention also can be made into capsule after adjuvant is changed, and it is as follows specifically to fill a prescription: 2-5 parts of soybean isoflavones, 3.5-7 parts of Radix Astragali extracts, 1-3 parts of Herb Gynostemmae Pentaphylli extracts, 4-8 parts of microcrystalline Cellulose or starch or cyclodextrin.(being mass fraction)
Instructions of taking: every day 1 time, each 1, eliminating cold for resuscitation water is taken.
Points for attention: vinegar-pepper, the wine of period in a medicine taboo.
The specific embodiment
Embodiment 1
A kind of drug products prescription for the treatment of female dimacteric syndrome is: soybean isoflavone 0.1kg, Radix Astragali extract 0.13kg, Herb Gynostemmae Pentaphylli extract 0.065kg, microcrystalline Cellulose 0.17kg, carboxymethyl starch sodium 0.03kg, magnesium stearate 0.003kg.
Its concrete preparation process is as follows:
1, preparation extract
Soybean isoflavone: leaching process is seen publication, and application number is: 1. 200510008536.9 pulverize low temperature soy meal, crosses 40～60 mesh sieves.2. alcoholic solution lixiviate: (equipment of employing is produced by Yuyao, Zhejiang grain machine factory in flat rotary extractor, model is YJPT5, treating capacity is 5T/D), low temperature soy meal 2.5t and extractant 85% ethanol water 7500L carry out continuous 16 stage countercurrent lixiviates under 50 ℃, can obtain the leaching liquid of high concentration; Concentrating under reduced pressure is removed ethanol whole in the leaching liquid, obtains the concentrated aqueous solution of low temperature soy meal.3. calcium hydroxide flocculation: in concentrated solution, add powdery calcium hydroxide adjust pH to 10～12, flocculate, leave standstill the 1h after-filtration, get yellow mud shape precipitation and yellow (muddy slightly) filtrate; Adding concentration is 20% hydrochloric acid in filtrate, and 2h is left standstill in adjust pH to 6～7, gets supernatant, and material liquid must flocculate.4. ethyl acetate extraction: adopt packed tower as extraction tower, tower diameter is 400mm, and tower height 6m, used filler are the porcelain system Raschig ring of specification 25 * 25 * 3; The food stage ethyl acetate is as continuous phase, feedstock direction from bottom to top, the flocculation material liquid is as decentralized photo, feedstock direction from top to bottom.Charging aperture is controlled by constant flow pump up and down, and last lower discharge port is controlled by valve.At first body of the tower is full of ethyl acetate, upper and lower opening charging simultaneously then, flocculation material liquid and raffinate flow are 1000L/h, extractant and extract flow are 4000L/h, after treating system stability, collect extract and raffinate, the ethyl acetate evaporate to dryness obtains the thick product 11.2kg of soybean isoflavone, purity is 41.5%, and extraction yield is 97.8%.5. petroleum ether extraction: with the 70L petroleum ether 41.5% the thick product of isoflavone is carried out recrystallization, obtain isoflavone product 4.6kg, purity is 97.8%, and extraction ratio is 96.8%, and total extraction ratio is 90.0%.
Radix Astragali extract: get crude drug Radix Astragali decoction pieces, add 10 times of water gagings (mass fraction) and decoct 2 times, each 1.5 hours, decoction liquor was filtered the back and is merged, and gets Radix Astragali extractive solution; Radix Astragali extractive solution is abandoned behind the supernatant the residue concentrating under reduced pressure, and condition is: 70 ℃, vacuum-0.1MPa to relative density 1.05～1.10 (50 ℃), adds 3 times of amount ethanol (volume parts) and makes precipitation, places, and inclining supernatant; Precipitate adds 50 ℃ hot water dissolving, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 70% (mass fraction), places, and inclining supernatant; Precipitate adds 50 ℃ hot water dissolving again, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 80% (mass fraction), places, and inclining supernatant, extractum; Gained extractum is carried out spray drying, promptly get Radix Astragali extract.
Herb Gynostemmae Pentaphylli extract: commercial (purchase in Xi'an Honson Biotechnology Co., Ltd., total saponin content of gynostemma pentaphyllum is 98%)
2, granulate
Respectively supplementary material is crossed 80 mesh sieves, get soybean isoflavone 0.1kg, Radix Astragali extract 0.13kg, Herb Gynostemmae Pentaphylli extract 0.065kg, microcrystalline Cellulose 0.17kg, carboxymethyl starch sodium 0.02kg (in add), mix homogeneously, it is an amount of to add 70% ethanol water, make soft material, cross 14 mesh sieves and granulate, 16 mesh sieve granulate are crossed in 50 ℃ of forced air dryings.
3, tabletting
Add 0.01kg carboxymethyl starch sodium (adding), magnesium stearate 0.003kg in the dried granule, mix homogeneously, 1000 of compressed tabletses, the heavy 0.5g/ sheet of sheet.
The clinical observation experiment method:
Use double blinding, at random, the method research observed of placebo outpatient, 30 experimenters are divided into two groups: the medicine group: take a slice medicine every day, matched group is taken the starch preparation.During treating, forbid taking preparations such as other bean food or estrogen.
2 months whole observation periods for the first time for the screening patient, promptly were called first, saw and treated patients for totally four times for every month afterwards twice.For the first time carry out classification marking (hectic fever is flushing, spontaneous sweating, vexed peaceful, insomnia and dreamful sleep, dizziness and tinnitus, depressed, easy fatigue, absent minded) to patient by 8 symptoms, each symptom marking standard is 1-3 minutes:
3 minutes, severe patient in the symptom.Its order of severity is impatient at for the patient, can not adhere to operate as normal, has influence on daily life, must go to hospital to seek medical advice.
2 minutes, symptom was moderate.Though perhaps have than the serious symptom shape, can also stand, adhere to general routine work.
1 minute, the lighter in the symptom.Symptom is relatively light, and the patient can carry out general work.During attention diversion, symptom is lighter relatively.
0 minute, without any symptom.
More than eight subjective symptoms, severe person's total points is 3 * 8=24 branch, moderate is 16 minutes, slightly is below 6 minutes.
Be subjected to examination to include standard in: all are participated in the observer and are married healthy women, and meet following condition:
1. typical climacteric syndrome is arranged, and comprehensive grading is more than 6 minutes.
2. decrease in estrogen in the blood, and flitropin (FSH) and flitropin (LH) level increase.
3. do not take hormones such as steroid in 3 months.
4. do not have breast carcinoma, uterus carcinoma, gestation, vaginal hemorrhage, cardiovascular diseases, hepatopathy, allergy etc. and both hoped medical history.The experimenter is divided into 2 groups at random, and two groups of patients all carry out conventional medicine inspection and lab testing.
Efficacy determination:
Change the judgement curative effect by comprehensive grading before and after 8 symptom treatments, and learn by statistics and handle.
Regular blood, urine, liver, renal function routine examination are adopted in the drug safety analysis.
The result:
30 routine patients are divided into two groups at random, medicine group experimenter's mean age is 51.8 ± 4.62, and menopause syndrome comprehensively is equally divided into 17.18 ± 3.12, and the placebo patients mean age is 50.53 ± 4.59, the comprehensive average mark of menopause syndrome is 16.86 ± 3.04, sees following table for details.Two groups of data no difference of science of statistics before and after taking medicine.
Take before and after medicine and the placebo relatively (x ± D) of menopause syndrome comprehensive grading
Compare before and after the treatment
*P＜0.05;
*P＜0.01
The medicine group is compared #P＜0.05 with placebo group; ##P＜0.01
Medicine group experimenter took medicine after February, and climacteric, 8 cardinal symptoms were clearly better, the symptom total points drop to 10.38 ± 3.04 with treatment before and compare after the treatment of comfort group significant difference all arranged.And before and after comfort group experimenter treated, 8 main subjective symptoms did not have and were clearly better climacteric, and the symptom total points still is 16.28 ± 2.42
Two groups of experimenters took medicine after February, and none example inspection is found blood, urine, liver, renal dysfunction.
The inventor adopts at random, double blinding and placebo method have been observed the therapeutical effect of medicine to climacteric syndrome.Observe by above-mentioned clinical experiment, can find, this medicine has tangible curative effect aspect the treatment climacteric syndrome.The result shows: two groups of experimenters each observations no difference of science of statistics before taking medicine.Medicine group experimenter took medicine after February, and climacteric, 8 main subjective symptoms were clearly better; And before and after comfort group experimenter treated, 8 main subjective symptoms did not have and were clearly better climacteric, showed that the thing that takes this medicine is useful to improving menopause syndrome.
Embodiment 2
A kind of drug products prescription for the treatment of female dimacteric syndrome is: soybean isoflavone 0.08kg, Radix Astragali extract 0.16kg, Herb Gynostemmae Pentaphylli extract 0.025kg, microcrystalline Cellulose 0.17kg, low-substituted hydroxypropyl cellulose 0.025kg, magnesium stearate 0.0025kg.
Its concrete preparation process is as follows:
1, preparation extract
Soybean isoflavone: leaching process is seen publication, and application number is: 1. 200510008536.9 pulverize low temperature soy meal, crosses 40～60 mesh sieves.2. alcoholic solution lixiviate: (equipment of employing is produced by Yuyao, Zhejiang grain machine factory in flat rotary extractor, model is YJPT5, treating capacity is 5T/D), low temperature soy meal 2.5t and extractant 85% ethanol water 7500L carry out continuous 16 stage countercurrent lixiviates under 50 ℃, can obtain the leaching liquid of high concentration; Concentrating under reduced pressure is removed ethanol whole in the leaching liquid, obtains the concentrated aqueous solution of low temperature soy meal.3. calcium hydroxide flocculation: in concentrated solution, add powdery calcium hydroxide adjust pH to 10～12, flocculate, leave standstill the 1h after-filtration, get yellow mud shape precipitation and yellow (muddy slightly) filtrate; Adding concentration is 20% hydrochloric acid in filtrate, and 2h is left standstill in adjust pH to 6～7, gets supernatant, and material liquid must flocculate.4. ethyl acetate extraction: adopt packed tower as extraction tower, tower diameter is 400mm, and tower height 6m, used filler are the porcelain system Raschig ring of specification 25 * 25 * 3; The food stage ethyl acetate is as continuous phase, feedstock direction from bottom to top, the flocculation material liquid is as decentralized photo, feedstock direction from top to bottom.Charging aperture is controlled by constant flow pump up and down, and last lower discharge port is controlled by valve.At first body of the tower is full of ethyl acetate, upper and lower opening charging simultaneously then, flocculation material liquid and raffinate flow are 1000L/h, extractant and extract flow are 4000L/h, after treating system stability, collect extract and raffinate, the ethyl acetate evaporate to dryness obtains the thick product 11.2kg of soybean isoflavone, purity is 41.5%, and extraction yield is 97.8%.5. petroleum ether extraction: with the 70L petroleum ether 41.5% the thick product of isoflavone is carried out recrystallization, obtain isoflavone product 4.6kg, purity is 97.8%, and extraction ratio is 96.8%, and total extraction ratio is 90.0%.
Radix Astragali extract: get crude drug Radix Astragali decoction pieces, add 8 times of water gagings (mass fraction) and decoct 2 times, each 1.3 hours, decoction liquor was filtered the back and is merged, and gets Radix Astragali extractive solution; Radix Astragali extractive solution is abandoned behind the supernatant the residue concentrating under reduced pressure, and condition is: 70 ℃, vacuum-0.1MPa to relative density 1.05～1.10 (50 ℃), adds 3 times of amount ethanol (volume parts) and makes precipitation, places, and inclining supernatant; Precipitate adds 70 ℃ hot water dissolving, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 75% (mass fraction), places, and inclining supernatant; Precipitate adds 70 ℃ hot water dissolving again, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 85% (mass fraction), places, and inclining supernatant, extractum; Gained extractum is carried out spray drying, promptly get Radix Astragali extract.
Herb Gynostemmae Pentaphylli extract: commercial (purchase in Xi'an Honson Biotechnology Co., Ltd., total saponin content of gynostemma pentaphyllum is 98%)
2, granulate
Respectively supplementary material is crossed 80 mesh sieves, get soybean isoflavone 0.08kg, Radix Astragali extract 0.16kg, Herb Gynostemmae Pentaphylli extract 0.025kg, microcrystalline Cellulose 0.17kg, low-substituted hydroxypropyl cellulose 0.025kg, mix homogeneously, it is an amount of to add 70% ethanol water, make soft material, cross 14 mesh sieves and granulate, 16 mesh sieve granulate are crossed in 50 ℃ of forced air dryings.
3, tabletting
Add magnesium stearate 0.0025kg in the dried granule, mix homogeneously, 1000 of compressed tabletses, the heavy 0.46g/ sheet of sheet.
Clinical observation:
By the method identical with embodiment 1, the medicine of embodiment 2 is carried out clinical observation, the result is as follows:
Medicine group experimenter took medicine after February, and climacteric, 8 cardinal symptoms were clearly better, and the symptom total points drops to 10.75 ± 2.94, significant difference was all arranged with comparing after (17.38 ± 3.06) and the comfort group treatment before the treatment.And before and after comfort group experimenter treated, 8 main subjective symptoms did not have and were clearly better climacteric, and the symptom total points still is 16.35 ± 2.56 (comfort group experimenter treat before symptom total points are 17.01 ± 3.16).This shows that the thing that takes this medicine is useful to improving menopause syndrome.
Embodiment 3
A kind of drug products prescription for the treatment of female dimacteric syndrome is: soybean isoflavone 0.08kg, Radix Astragali extract 0.15kg, Herb Gynostemmae Pentaphylli extract 0.05kg, microcrystalline Cellulose 0.18kg, low-substituted hydroxypropyl cellulose 0.035kg, magnesium stearate 0.0027kg.
Its concrete preparation process is as follows:
1, preparation extract
Soybean isoflavone: leaching process is seen publication, and application number is: 1. 200510008536.9 pulverize low temperature soy meal, crosses 40～60 mesh sieves.2. alcoholic solution lixiviate: (equipment of employing is produced by Yuyao, Zhejiang grain machine factory in flat rotary extractor, model is YJPT 5, treating capacity is 5T/D), low temperature soy meal 2.5t and extractant 85% ethanol water 7500L carry out continuous 16 stage countercurrent lixiviates under 50 ℃, can obtain the leaching liquid of high concentration; Concentrating under reduced pressure is removed ethanol whole in the leaching liquid, obtains the concentrated aqueous solution of low temperature soy meal.3. calcium hydroxide flocculation: in concentrated solution, add powdery calcium hydroxide adjust pH to 10～12, flocculate, leave standstill the 1h after-filtration, get yellow mud shape precipitation and yellow (muddy slightly) filtrate; Adding concentration is 20% hydrochloric acid in filtrate, and 2h is left standstill in adjust pH to 6～7, gets supernatant, and material liquid must flocculate.4. ethyl acetate extraction: adopt packed tower as extraction tower, tower diameter is 400mm, and tower height 6m, used filler are the porcelain system Raschig ring of specification 25 * 25 * 3; The food stage ethyl acetate is as continuous phase, feedstock direction from bottom to top, the flocculation material liquid is as decentralized photo, feedstock direction from top to bottom.Charging aperture is controlled by constant flow pump up and down, and last lower discharge port is controlled by valve.At first body of the tower is full of ethyl acetate, upper and lower opening charging simultaneously then, flocculation material liquid and raffinate flow are 1000L/h, extractant and extract flow are 4000L/h, after treating system stability, collect extract and raffinate, the ethyl acetate evaporate to dryness obtains the thick product 11.2kg of soybean isoflavone, purity is 41.5%, and extraction yield is 97.8%.5. petroleum ether extraction: with the 70L petroleum ether 41.5% the thick product of isoflavone is carried out recrystallization, obtain isoflavone product 4.6kg, purity is 97.8%, and extraction ratio is 96.8%, and total extraction ratio is 90.0%.
Radix Astragali extract: get crude drug Radix Astragali decoction pieces, add 12 times of water gagings (mass fraction) and decoct 2 times, each 3 hours, decoction liquor was filtered the back and is merged, and gets Radix Astragali extractive solution; Radix Astragali extractive solution is abandoned behind the supernatant the residue concentrating under reduced pressure, and condition is: 70 ℃, vacuum-0.1MPa to relative density 1.05～1.10 (50 ℃), adds 4 times of amount ethanol (volume parts) and makes precipitation, places, and inclining supernatant; Precipitate adds 60 ℃ hot water dissolving, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 73% (mass fraction), places, and inclining supernatant; Precipitate adds 60 ℃ hot water dissolving again, filters, and filtrate adds ethanol again to be made and contain the alcohol amount and reach 83% (mass fraction), places, and inclining supernatant, extractum; Gained extractum is carried out spray drying, promptly get Radix Astragali extract.
Herb Gynostemmae Pentaphylli extract: commercial (purchase in Xi'an Honson Biotechnology Co., Ltd., total saponin content of gynostemma pentaphyllum is 98%)
2, granulate
Respectively supplementary material is crossed 80 mesh sieves, get soybean isoflavone 0.08kg, Radix Astragali extract 0.15kg, Herb Gynostemmae Pentaphylli extract 0.05kg, microcrystalline Cellulose 0.18kg, low-substituted hydroxypropyl cellulose 0.025kg (in add), mix homogeneously, it is an amount of to add 70% ethanol water, make soft material, cross 14 mesh sieves and granulate, 16 mesh sieve granulate are crossed in 50 ℃ of forced air dryings.
3, tabletting
Add 0.01kg carboxymethyl starch sodium (adding), magnesium stearate 0.0027kg in the dried granule, mix homogeneously, 1000 of compressed tabletses, the heavy 0.52g/ sheet of sheet.
Clinical observation:
By the method identical with embodiment 1, the medicine of embodiment 3 is carried out clinical observation, the result is as follows:
Medicine group experimenter took medicine after February, and climacteric, 8 cardinal symptoms were clearly better, and the symptom total points drops to 10.59 ± 3.01, significant difference was all arranged with comparing after (17.09 ± 3.15) and the comfort group treatment before the treatment.And before and after comfort group experimenter treated, 8 main subjective symptoms did not have and were clearly better climacteric, and the symptom total points still is 16.49 ± 2.63 (comfort group experimenter treat before symptom total points are 17.20 ± 3.21).This shows that the thing that takes this medicine is useful to improving menopause syndrome.
Claims (2)
1. medicine for the treatment of female dimacteric syndrome, it is characterized in that, composition by following mass fraction is made: 2-5 parts of soybean isoflavones, 3.5-7 parts of Radix Astragali extracts, 1-3 parts of Herb Gynostemmae Pentaphylli total glycosidess, 4-8 parts of microcrystalline Cellulose, 0.5-1.5 parts of carboxymethyl starch sodium or low-substituted hydroxypropyl celluloses, 0.05-0.15 part of magnesium stearate;
Described Radix Astragali extract preparation method is as follows: get crude drug Radix Astragali decoction pieces, add 8-12 mass parts several times water gagings and decoct 2 times, each 1-3 hours, decoction liquor was filtered the back and is merged, and gets Radix Astragali extractive solution; Radix Astragali extractive solution is abandoned behind the supernatant the residue concentrating under reduced pressure, and condition is: 70 ℃, vacuum-0.1MPa is 1.05～1.10 during to 50 ℃ of relative densities, adds 2-4 volumes and doubly measures ethanol and make precipitation, places, and inclining supernatant; Precipitate adds 50 ℃-70 ℃ hot water dissolving, filters, and filtrate adds ethanol again to be made and contain alcohol amount mass fraction and reach 70%-75%, places, and inclining supernatant; Precipitate adds 50 ℃-70 ℃ hot water dissolving again, filters, and filtrate adds ethanol again to be made and contain alcohol amount mass fraction and reach 80%-85%, places, and inclining supernatant, extractum; Gained extractum is carried out spray drying, promptly get Radix Astragali extract.
2. the preparation method of the medicine of treatment female dimacteric syndrome according to claim 1 comprises extraction-granulation-tabletting, it is characterized in that may further comprise the steps:
1, preparation extract
The preparation soybean isoflavone:
1) low temperature soy meal is pulverized, crossed 40～60 mesh sieves, get the low temperature soy meal powder;
2) low temperature soy meal powder and extractant 50～90% ethanol waters carry out the continuous multi-stage countercurrent lixiviate under 45～85 ℃, the mass volume ratio kg/L of low temperature soy meal powder and extractant is 1:2～5, obtain the ethanol leaching liquid reduction vaporization of low temperature soy meal, remove ethanol, obtain the soybean isoflavone concentrated aqueous solution;
3) adding calcium hydroxide in the soybean isoflavone concentrated aqueous solution of step (2), to regulate pH value be 8～12, flocculation, leave standstill remove flocculate precipitate after, regulate pH value to 6～7 with hydrochloric acid, flocculation, leave standstill remove flocculate after, obtain the material liquid that flocculates;
4) with the ethyl acetate be extractant, the flocculation material liquid of step 3) is extracted that concentrating under reduced pressure is removed ethyl acetate, obtain purity and be about 40% the thick product of soybean isoflavone, extraction yield is more than 95%;
5) the thick product of the soybean isoflavone of step 4) carries out recrystallization with petroleum ether, and petroleum ether is 5～9:1 with the volume mass of the thick product of soybean isoflavone than L/kg, can obtain the soybean isoflavone product of purity more than 95%;
The preparation Radix Astragali extract:
2, granulate
Respectively raw material is crossed 80 mesh sieves, 2-5 parts of soybean isoflavones, 3.5-7 parts of Radix Astragali extracts, 1-3 parts of Herb Gynostemmae Pentaphylli total glycosidess, 4-8 parts of microcrystalline Cellulose, 0.5-1.5 parts of 0.3-0.9 part of carboxymethyl starch sodium or low-substituted hydroxypropyl celluloses, mix homogeneously, it is an amount of to add 70% ethanol water, make soft material, cross the 12-18 mesh sieve and granulate, 12-18 mesh sieve granulate is crossed in 50 ℃ of forced air dryings;
3, tabletting
Add 0.05-0.15 part of 0.2-0.6 part of carboxymethyl starch sodium, magnesium stearate, mix homogeneously, compressed tablets in the dried granule.
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