CN1602950A - Pharmaceutical composition for treating climacteric syndrome and its preparing process - Google Patents
Pharmaceutical composition for treating climacteric syndrome and its preparing process Download PDFInfo
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Abstract
The invention discloses one medicine fabric which is used to treat the woman menopause syndrome, it is composed by, pregnant Yang Huo, the yellow Manchurian crane grass, the asses' glue, the fruit of the Chinese wolfberry, leonurus siribicus and raw material and so on Chinese rhubarb according to a certain proportion.The medicine fabric has a good treatment result to treat the woman menopause syndrome.Simultaneously this invention has also discloses this medicine fabric preparation method, namely through suitable withdraws the concentration craft,to make clinical needs dosage-form.
Description
Technical field
The invention discloses a kind of pharmaceutical composition that is used for the treatment of menopausal syndrome and preparation method thereof, belong to the field of Chinese medicines
Background technology
Woman climacteric be the middle age to the transition period in old age, mainly be that the women's ovary function is faded to the process of complete obiteration, its time of origin is generally between 45-55 year.Though this is the physiological phenomenon of women's certainty in the latter half of one's life, but the women of quite a few occurs during this period owing to gonadal hormone reduces a series of symptoms and the complication that causes, and moderate or severe symptom can appear in nearly about 20% climacteric women, and may be, even can produce the distracting thoughts of committing suicide with a series of mental symptom.In addition, if in involutional, the severe symptom do not treated, but diseases such as secondary arrhythmia, hypertension, hyperlipemia, diabetes, atherosclerosis, osteoporosis, alzheimer disease.
In recent years, along with country and society to the propaganda of female health, existing increasing women pays close attention to involutional malaise symptoms, and can in time seek medical advice and take medicine, this ability to shoulder economically and consuming capacity enhancing with China women has close getting in touch.Simultaneously, the quickening of social senilization's process, the number of women that also makes China be about to enter into the climacteric period increases sharply.According to estimates, will reach 1.6 hundred million, 2010 to the women of China more than 50 years old in 2005 and reach 1.8 hundred million.Wherein there is 10%～15%, 4%～5% the people that has approximately of obvious menopause syndrome that serious symptoms is then arranged.So how to make women's safety tide over climacteric, have the health in old age of physiology and psychology, be the focus of medical circle research always.And the climacteric syndrome medicine is being contained the huge market space especially.
It mainly is to use controversies in hormone replacement in the elderly (ERT) that modern medicine is treated menopausal syndrome at present, so far the history in year surplus in the of existing 50.Clinical confirmation, ERT can prevent even reverse climacteric women coronary heart disease, cerebrovascular, senile dementia, osteoporosis, delays the decline of ovarian function, makes the women keep good physiological function and mental status, improves the quality of life of climacteric women.But its defective is, prolonged application ERT might bring out breast carcinoma, carcinoma of endometrium, and may produce untoward reaction such as irregular hemorrhage, the weight increase of vagina, and resonable touching upon still has many an open questions in clinical, as the mutual relation between the various gonadal hormone (estrogen, androgen, progestogen), problems such as the effect of gonadal hormone, dosage, ratio and SM time, drug usage individuation, so that the popularization of ERT be restricted.
Motherland's traditional medicine thinks that then the conscience kidney is become estranged, and is the crucial pathogenesis that takes place climacteric, but is basis to suffer from a deficiency of the kidney.The kidney essense abundance, then kidney qi is in harmonious proportion, and is quiet and keep the position, unlikely in vehement rash action.And to over seventy-seven (promptly 49 years old, the general age of taking place with climacteric matches), the essence and blood loss, then kidney qi does not have institute's usage, guards dereliction, on disturb conscience, but gods are upset in then priming flaming up of the ministerial fire, and it is peaceful to cause the state of mind to be lost, rise in the asthenic fire, perspiration, uneasy sleeping at night, nervous cardiopalmus occur warming, cry and laugh by turns, without any apparent reason, symptom such as vertigo and tinnitus.So the kidney invigorating, regulating liver-QI, regulation of mental activities are the main rules of treatment climacteric syndrome, also are the most widely used clinically at present rule of treatment.But the Chinese medicine of actual existing treatment climacteric syndrome, comprise that GENGNIANAN PIAN, the peaceful ball of climacteric, the peaceful sheet of the kidney invigorating, female precious ball, the refreshing curing capsule that relaxes, the female peaceful tincture of benefit, norlutin, the happy sheet of climacteric, the goddess in the moon add beautiful ball, climacteric curing capsule, the easypro sheet of climacteric etc., on curing mainly or the kidney invigorating, or warming YANG, or YIN nourishing, all be partial to an a corner, and disclosed prescription also mainly is a symptom of improving the climacteric syndrome hyperactivity of fire caused by deficiency of YIN among CN1488385A and the CN1468614A.Though these existing square medicines produce effect, and unsatisfactory.
Summary of the invention
The inventor is according to the defective of existing medicine, and through years of researches, the void that proposes the kidney yin kidney yang all can cause the viewpoint of the stasis of blood, thinks and should note tonification gate of vitality vital essence aspect the medication of treatment renal deficiency type climacteric syndrome, should control with negative and positive are two; In the time of nourshing blood and promoting blood circulation, also want blood stasis dispelling to stimulate the menstrual flow.This viewpoint has embodied the critical role of blood stasis in the middle of the primary disease pathogenesis, emphasizes the kidney invigorating while, also answers blood stasis dispelling to stimulate the menstrual flow; Tonifying both YIN and YANG, treating both the principal and secondary aspects of a disease can be obtained special effect.According to this new viewpoint, the inventor has developed following prescription:
Herba Epimedii 9-15 weight portion Radix Astragali 4-8 weight portion Herba Agrimoniae 4-8 weight portion Colla Corii Asini 1-3 weight portion
Fructus Lycii 2-4 weight portion Herba Leonuri 2-4 weight portion Radix Et Rhizoma Rhei 1-3 weight portion
Among this side, the inventor has introduced the notion of Chinese medicine " gate of vitality ".Though the relation of the gate of vitality and kidney has multiple viewpoint in Chinese medicine, the two is inseparable on physiological function.Why be referred to as " gate of vitality " exactly because it is strong directly related always with people's bulk-growth.The gate of vitality is that the institute of human body primordial essence vigour occupies, and essence and gas phase be usefulness each other, make each other mutually, and be the driving source of human life, and menses also is one of composition of primordial essence vigour.When human body enters into the climacteric period, primordial essence vigour occurs losing empty, menses day degradation few, the unusual of various pathology and psychological aspects just can appear in the internal organs imbalance of YIN and YANG.So this side serves as basic with " tonification gate of vitality vital essence " aspect the rule of treatment, reuses Herba Epimedii, its sweet in the mouth is warm in nature, goes into Liver and kidney two warps, can the kidney invigorating and essence nourishing, promote the generation of menses.And the Radix Astragali is sweet, warm, strengthening QI of middle-JIAO, and the yang invigorating strengthening superficial resistance to stop perspiration is to grow the source of blood; Herba Agrimoniae GUIXIN, Liver Channel, astringing to arrest bleeding, but and compensate qi and blood, help to regain one's strength; Two medicines share, but enrich and benefit essence and blood, nourishingization source, QI invigorating and blood producing.Also has the Fructus Lycii nourishing kidney-yin, nourishing the liver blood; The Colla Corii Asini nourishing blood YIN nourishing is moisturized, hemostasis.This two medicines nourishing kidney yin closes the Radix Astragali, Herba Agrimoniae benefit intensive culture blood hemopoietic, plays the effect of tonifying both YIN and YANG altogether with Herba Epimedii.Say as the traditional Chinese medical science: kind YANG invigorating person, must be in treating YANG within YIN, then positive cloudy helping and biochemical infinite; Kind nourishing YIN person must be in treating YIN within YANG, then cloudy positive liter, and source is inexhaustible.Simultaneously, because of the climacteric syndrome disease at deficiency of kidney-YIN, depletion of body fluid causing lack of blood, blood viscous can not be followed and forms the stasis of blood through passing unimpeded and stagnate; If insufficiency of kidney-YANG, can not be warm and promote blood operation, form the stasis of blood and stagnate.And the Herba Leonuri pungent drugs can disperse and bitter drugs can descend, promoting blood flow to regulate menstruation, inducing diuresis to remove edema, but blood circulation promoting and blood stasis dispelling is to stimulate the menstrual flow; Radix Et Rhizoma Rhei can purging heat to relax the bowels, and removing pathogenic heat from blood and toxic substance from the body cleanses stasis of blood deteriorated blood with fixed attention, and it is descending to draw blood stasis, the effect of playing eliminating blood stasis and inducing menstruation altogether with Herba Leonuri.Full side holds on to the basic of menses degradation, take into account involutional various symptom, specimen is two to be controlled, reinforcing and reducing are with using, though can not reverse the natural law of menses decay, can make this process become slow relatively, so that body produces adaptability gradually to this variation, cause other illness and be unlikely to lack of proper care suddenly, make patient's safety successfully tide over this particular time of climacteric because of negative and positive.
In above drug ratio scope, all can reach therapeutic effect, after the inventor further studies, draw optimum ratio:
The Herba Epimedii 12 weight portion Radixs Astragali 6 weight portion Herba Agrimoniaes 6 weight portion Colla Corii Asini 2 weight portions
Fructus Lycii 3 weight portion Herba Leonuris 3 weight portion Radix Et Rhizoma Rhei 2 weight portions
Therefore it is longer that the course of treatment is taken by the side, and Radix Et Rhizoma Rhei discharge function power is strong, and for weakening its side effect, available Radix et Rhizoma Rhei (processed) substitutes, and promptly gets rhubarb tablets and spray with yellow wine, vexed after drying and getting.A little less than Radix et Rhizoma Rhei (processed) rushes down and exerts oneself, and the power of eliminating blood stasis and inducing menstruation does not subtract, so drug effect is better.
More than all medicines of prescription for the crude drug of pharmaceutical composition of the present invention, are taken for the ease of the patient, the inventor designed should the side the extraction preparation method:
A) get Herba Epimedii and Radix et Rhizoma Rhei (processed), add 5-9 times of 60%-80% alcohol heating reflux respectively and extract 2-3 time, each 1-2 hour, filter, medicinal residues device are in addition preserved, and filtrate merges the back decompression recycling ethanol, and relative density is 1.30～1.35 extractum when being concentrated into 60 ℃, and is standby;
B) get that medicinal residues merge after the Radix Astragali, Herba Agrimoniae, Herba Leonuri, Fructus Lycii and the alcohol extraction, add 9-11 times of decocting respectively and boil 2-3 time, each 1-2 hour, filtration, merging filtrate, relative density is 1.30～1.35 extractum when being concentrated into 60 ℃, and is standby;
C) get the Colla Corii Asini molten, with the extractum mix homogeneously after above-mentioned alcohol extraction, the water boiling concentration;
D) the said mixture crushed after being dried is become fine powder.
Behind the preferred parameter, it is as follows to obtain the optimum process flow process:
A) get Herba Epimedii and Radix et Rhizoma Rhei (processed), extract 3 times with 70% alcohol heating reflux, each alcohol adding amount is for being respectively 7,7,5 times, each return time each 1.5 hours, filter, medicinal residues device are in addition preserved, and filtrate merges the back decompression recycling ethanol, and relative density is 1.32～1.35 extractum when being concentrated into 60 ℃, and is standby;
B) get that medicinal residues merge after the Radix Astragali, Herba Agrimoniae, Herba Leonuri, Fructus Lycii and the alcohol extraction, decoct with water 2 times, amount of water is respectively 11 times, 9 times, decocting time each 1.5 hours filters merging filtrate, and relative density is 1.32～1.35 extractum when being concentrated into 60 ℃, and is standby;
C) get the Colla Corii Asini molten, with the extractum mix homogeneously after above-mentioned alcohol extraction, the water boiling concentration;
D) with said mixture in 60 ℃ of drying under reduced pressure, be ground into fine powder.
In above-mentioned technical process, drying means can be present various technology commonly used, comprises normal pressure, decompression and spray drying, after consider the status of equipment of technical costs and at present big portion pharmaceutical producing enterprise, drying under reduced pressure is an optimal case when finally selecting 60 ℃ for use.
The extract fine powder that obtains by above preparation method, can be as required, add different adjuvants commonly used, as disintegrating agent, lubricant, binding agent etc., method of Chinese medicinal with routine is made into various peroral dosage forms, as tablet, capsule, soft capsule and granule etc., be preferably granule.
Therapeutic effect for pharmaceutical composition of the present invention, once by animal pharmacodynamics laboratory observation its influence to animal maincenter and nervous function, to the influence of hypothalamus one hypophysis one hypothalamic pituitary ovarium axis function,, and set upright supporing yang effect to the influence of hybrid dog cardiac function.The result shows: 1. the normal mouse autonomic activities is had certain inhibitory action, and can alleviate rat and mice sweat secretion due to the pilocarpine, the antagonism caffeine causes mice convulsion outbreak and electricity irritation and causes mice and get angry, promote the sleep of pentobarbital sodium in mice and rat, improve memory acquisition disturbance learning and memory abilities in aging mice due to old rats and the Anisodine; 2. increase removal ovary rat and mouse uterine weight, vaginal epithelial cell keratinization ability and serum estradiol content, and can reduce removal ovary rat blood serum follicule-stimulating hormone (FSH), interstitialcellstimulating hormone (ICSH), Bone Gla protein and content of alkaline phosphatase; 3. increase insufficiency of kidney-YANG mice body weight due to the hydrocortisone, body temperature, thymus body than, spleen body than and 4 ℃ of water in swimming time, improve normal mouse peritoneal macrophage phagocytic activity; 4. increase anesthetized dog cardiac output, coronary flow, whenever fight heart output, the work done of left chamber, cardiac index, SI, reduce coronary resistance and Peripheral resistance, blood pressure, heart rate, left indoor pressure, myocardial oxygen consumption and myocardium coefficient of oxygen utilization etc. are not seen obvious influence.Prompting, pharmaceutical composition of the present invention is inhibited to maincenter and vegetative nerve exaltation, the gonad axis dysfunction changed after the estrogen-like effects that it had can improve removal ovary, and may have certain preventive and therapeutic effect to high conversion type osteoporosis, this medicine also has the insufficiency of kidney-YANG of improvement sign, enhancing body non-specific immunity and anti-fatigue at low temperatures effect simultaneously, and the improvement of cardiac function is also had certain effect.
On above zooperal basis, carried out clinical experiment again.Below just specify drug regimen of the present invention menopausal syndrome had concurrently blood stasis patient's therapeutical effect by the clinical experiment example, test used medicine " stilbene benefit granule " and make by optimal proportion of the present invention and optimum process.
1 clinical research purpose: observe stilbene benefit granule to the treatment of climacteric syndrome effect
The object of observation: select menoxenia before and after the menopause, belong to the anemia of suffering from a deficiency of the kidney and hold that female patient of climacteric syndrome 34 examples are the object of observation, 45～55 years old age due to the stasis of blood under the arm, 49 years old mean age, the course of disease 6 months～2.5 years, disease opinion is warmed sweating, vexed not peaceful, dizzy weak, soreness of the waist and knees, or talalgia, little sleep disturbed by dreams, be hard and dry, menoxenia, color is dark under the blood, has held stasis of blood piece under the arm, the dark red tongue of tongue is few, thready pulse.Wherein with warming sweating person's 32 examples, irritated guerulent's 25 examples, chest distress and palpitation symptoms person's 19 examples, insomnia forgetfulness person 15 examples, waist and leg ache person 14 examples, dizzy weak person's 17 examples.
Diagnostic criteria: " new Chinese medicine clinical research guideline " according to Ministry of Health of the People's Republic of China's promulgation in 1997 selected about the diagnostic criteria and the documents and materials of " menopausal syndrome ": (1) age is between 44～55 years old; (2) have climacteric to warm classical symptoms such as hyperhidrosis, irritated irritability, chest distress and palpitation symptoms, insomnia forgetfulness, waist and leg ache, all patients are all with purplish tongue or ecchymosis, petechia are arranged, deficient pulse or thin or string is puckery; (3) lab testing blood estradiol (E
2)＜40 μ g/L, follicle stimulating hormone (FSH)＞40U/L, lutropin (LH)＞25U/L; (4) get rid of side oophorectomize, ovarian tumor or premature ovarian failure person, hyperthyroidism, cardiovascular and cerebrovascular disease, psychosis, bone, joint disease patient.
2 methods
2.1 Therapeutic Method: take stilbene benefit granule, one day 3 times, each 10g, the dosage of every day is equivalent to crude drug 36g; 4 weeks were 1 course of treatment, carried out efficacy evaluation after taking 2 courses of treatment continuously, the other treatment medicine of stopping using during the treatment.
2.2 observed content: difference before and after the treatment: (1) observed and recorded patient sign, symptom variation; (2) adopt SN-682 type radioimmunity gamma counter (Shanghai nuclear good fortune photoelectric instrument company limited product) to put the method for exempting from and measure serum E
2, FSH and LH value (put exempt from medicine box be Tianjin Li Ke company product), and obtain the difference of each index before treatment back and the treatment; (3) adopt R80 type cone-plate formula automatic blood flow graph (Beijing Steellex Scientific Instrument Company's product) to carry out the hemorheology detection, and obtain the difference of treatment back and preceding each index of treatment.During mensuration room temperature constant be 25 ± 0.2 ℃, the blood viscosity shear rate is decided to be 60s
-1
2.3 statistical procedures: adopt the institute's NDST that compiles 8.0 software data processings such as Sun Rui unit, ranked data are checked processing with Ridit, and measurement data is checked with t.
3 results
3.1 efficacy assessment standard: selecting to warm symptoms such as hyperhidrosis, irritated irritability, chest distress and palpitation symptoms, insomnia forgetfulness, waist and leg ache, dizzy weak, body of the tongue stasis of blood purple was MAIN OUTCOME MEASURES, according to the light and heavy degree note of each symptom 0～3 minute.Standards of grading: serious symptom, can not work, the palpus bed or the person of being hospitalized for treatment remember 3 fens; Symptom is heavier, and the person remembers 2 fens but can adhere to the general work; Symptom is lighter, and the worker remembers 1 fen but need not take medicine also; Do not have this symptom and remember 0 fen.Is the efficacy determination foundation with each symptom total mark difference before and after each patient treatment with the ratio size for the treatment of preceding total mark, and ratio 〉=85% is to alleviate fully; Ratio 〉=50% is a produce effects; Ratio 〉=20% is effective; Ratio＜20% is invalid.
3.2 therapeutic outcome
3.2.1 doing well,improving and efficacy result before and after the treatment
Treat after 2 months, two groups of patient's doing well,improvings and efficacy result see Table 1 and table 2 respectively.
Cardinal symptom appraisal result before and after the table 1 stilbene benefit granule therapy
| Symptom | Different light and heavy degree patient with sympotoms numbers | P value (before the VS treatment) | |||||||
| Before the treatment | After the treatment | ||||||||
| 0 minute | 1 minute | 2 minutes | 3 minutes | 0 minute | 1 minute | 2 minutes | 3 minutes | ||
| Warm hyperhidrosis | 2 | 7 | 14 | 11 | 13 | 17 | 4 | 0 | ＜0.01 |
| Irritated irritability | 9 | 8 | 8 | 9 | 15 | 15 | 3 | 1 | ＜0.01 |
| Chest distress and palpitation symptoms | 15 | 3 | 10 | 6 | 25 | 6 | 3 | 0 | ＜0.01 |
| Insomnia forgetfulness | 19 | 9 | 6 | 0 | 28 | 5 | 1 | 0 | ＜0.05 |
| Waist and leg ache | 21 | 4 | 6 | 3 | 30 | 2 | 2 | 0 | ＜0.05 |
| Dizzy weak | 17 | 7 | 9 | 1 | 31 | 1 | 2 | 0 | ＜0.01 |
| Body of the tongue stasis of blood purple | 0 | 34 | 0 | 0 | 30 | 4 | 0 | 0 | ＜0.01 |
1 result shows, take stilbene benefit granule after, compare all to have in various degree before each cardinal symptom of patient and the treatment and alleviate.Ridit method assay shows, comparing before each symptom and the treatment all has significant difference (P＜0.05 or P＜0.01) prompting has obvious effects.
Table 2 stilbene benefit granule is to the efficacy result of climacteric syndrome
| Classification | Alleviate example fully | The produce effects example | Effectively routine | Invalid example | Amount to |
| The example number | 14 | 17 | 2 | 1 | 34 |
| Ratio | 41.2％ | 50.0％ | 5.9％ | 2.9％ | 100.0％ |
Table 2 result shows, in 34 examples of stilbene benefit granule therapy, alleviate fully 14 examples (account for this organize total routine number 41.2%), produce effects 17 examples (accounting for 50.0%), effective 2 examples (accounting for 5.9%), invalid 1 example (accounting for 2.9%), total effective rate reaches 97.1%.
3.2.2 blood E before and after the treatment
2, FSH and LH result of variations
Patient's blood E before and after the table 3 stilbene benefit granule therapy climacteric syndrome
2, FSH and LH change
| Index | E2(μg/L) | FSH(U/L) | LH(U/L) |
| Before the treatment | 32.7±6.8 | 54.9±14.2 | 41.2±12.5 |
| After the treatment | 41.3±10.3 ** | 49.3±15.0 ** | 34.3±11.1 ** |
| Difference | 8.6±7.8 | -5.6±6.0 | -6.9±3.8 |
It is relatively preceding with treatment,
*P＜0.05,
*P＜0.01.
The result shows, medication is after 2 months, E
2Value raises, and FSH and LH value then reduce, and comparing before each desired value and the treatment all has the significance meaning (P＜0.05 or P＜0.01), points out the beneficial granule of stilbene that the improvement of These parameters is had tangible effect.
3.2.3 hemorheology index result of variations before and after the treatment
Before the treatment and treatment after 2 months patient's hemorheology index change and to see Table 4.
Hemorheology index changes before and after the table 4 stilbene benefit granule therapy climacteric syndrome
| Index | Whole blood viscosity (mPas) | Plasma viscosity (mPas) | Packed cell volume (%) |
| Before the treatment | 5.28±1.33 | 1.67±0.39 | 42.27±10.84 |
| After the treatment | 4.70±0.96 ** | 1.51±0.52 * | 38.12±10.90 ** |
| Difference | -0.58±0.61 | -0.16±0.10 | -4.15±4.53 |
It is relatively preceding with treatment,
*P＜0.05,
*P＜0.05.
The result shows that patient's whole blood viscosity, plasma viscosity and packed cell volume value all significantly are lower than treatment preceding (P＜0.05 or P＜0.01), and prompting stilbene benefit granule has therapeutical effect to above-mentioned disease.
As fully visible, pharmaceutical composition of the present invention is to menopausal syndrome, and still it is that the various symptom tools that have the patient of blood stasis concurrently improve significantly, and demonstrates excellent curative, has reached purpose of the present invention.
Embodiment:
Embodiment 1: the preparation of capsule of the present invention
Prescription: Herba Epimedii 9kg Radix Astragali 4kg Herba Agrimoniae 4kg Colla Corii Asini 1kg
Fructus Lycii 2kg Herba Leonuri 2kg Radix Et Rhizoma Rhei 1kg
Method for making: get Herba Epimedii and Radix Et Rhizoma Rhei, add 60% alcohol heating reflux and extract 2 times, add 5 times of amounts of alcohol at every turn, refluxed 1 hour, and filtered, medicinal residues device are in addition preserved, filtrate merges the back decompression recycling ethanol, and relative density is 1.30～1.32 extractum when being concentrated into 60 ℃, and is standby; Get that medicinal residues merge after the Radix Astragali, Herba Agrimoniae, Herba Leonuri, Fructus Lycii and the alcohol extraction, decoct with water 2 times, add 9 times of amounts of water at every turn, decocted 1 hour, filtration, merging filtrate, and relative density is 1.30～1.32 extractum when being concentrated into 60 ℃, standby; Get the Colla Corii Asini molten, with the extractum mix homogeneously after above-mentioned alcohol extraction, the water boiling concentration, drying under reduced pressure is ground into fine powder, and with alcohol granulation, capsule is dressed up in oven dry.
Embodiment 2: the preparation of tablet of the present invention
Prescription: Herba Epimedii 15kg Radix Astragali 8kg Herba Agrimoniae 8kg Colla Corii Asini 3kg
Fructus Lycii 4kg Herba Leonuri 4kg Radix Et Rhizoma Rhei (system) 3kg
Method for making: get Herba Epimedii and Radix et Rhizoma Rhei (processed), add 80% alcohol heating reflux and extract 3 times, add 9 times of amounts at every turn, refluxed 2 hours, and filtered, medicinal residues device are in addition preserved, filtrate merges the back decompression recycling ethanol, and relative density is 1.33～1.35 extractum when being concentrated into 60 ℃, and is standby; Medicinal residues merge after getting the Radix Astragali, Herba Agrimoniae, Herba Leonuri, Fructus Lycii and alcohol extraction, decoct with water 3 times, add 11 times of amounts of water at every turn, decoct 2 hours, filter, and merging filtrate, relative density is 1.33～1.35 extractum when being concentrated into 60 ℃, and is standby; Get the Colla Corii Asini molten, with the extractum mix homogeneously after above-mentioned alcohol extraction, the water boiling concentration, spray drying is made fine powder; Add an amount of carboxymethylstach sodium, microcrystalline Cellulose and magnesium stearate in fine powder, compacting in flakes.
Embodiment 3: the preparation of granule of the present invention
Prescription: Herba Epimedii 12kg Radix Astragali 6kg Herba Agrimoniae 6kg Colla Corii Asini 2kg
Fructus Lycii 3kg Herba Leonuri 3kg Radix Et Rhizoma Rhei (system) 2kg
Method for making: get Herba Epimedii, Radix Et Rhizoma Rhei (system) with 70% alcohol heating reflux extraction 3 times, alcohol adding amount is respectively 7,7,5 times, return time each 1.5 hours, filter, medicinal residues device are in addition preserved, filtrate merges the back decompression recycling ethanol, and relative density is 1.32～1.35 extractum when continuing to be concentrated into 60 ℃, and is standby.Medicinal residues merge after getting the Radix Astragali, Herba Agrimoniae, Herba Leonuri, Fructus Lycii and alcohol extraction, decoct with water 2 times, add the water multiple and are respectively 11,9 times, decocting time respectively is 1.5 hours, filters merging filtrate, relative density is 1.32～1.35 extractum when being concentrated into 60 ℃, and is standby.Other gets the Colla Corii Asini molten, and with extractum uniform mixing after alcohol extraction, the water boiling concentration, 60 ℃ of drying under reduced pressure are ground into fine powder, add an amount of soluble dextrins and 0.01% cyclamate, and mixing is dry below 40 ℃ with alcohol granulation, makes granule.
Claims (1)
1.[document source] electronic application
2.[the message in-coming date] 2004-11-9
3.[application number]
4.[claim item]
[claim 1] a kind of pharmaceutical composition that is used for the treatment of menopausal syndrome is characterized in that this pharmaceutical composition is to be made by the crude drug of following weight ratio:
Herba Epimedii 9-15 weight portion Radix Astragali 4-8 weight portion Herba Agrimoniae 4-8 weight portion Colla Corii Asini 1-3 weight portion
Fructus Lycii 2-4 weight portion Herba Leonuri 2-4 weight portion Radix Et Rhizoma Rhei 1-3 weight portion
[claim 2] is pharmaceutical composition according to claim 1, it is characterized in that the ratio of each crude drug is:
The Herba Epimedii 12 weight portion Radixs Astragali 6 weight portion Herba Agrimoniaes 6 weight portion Colla Corii Asini 2 weight portions
Fructus Lycii 3 weight portion Herba Leonuris 3 weight portion Radix Et Rhizoma Rhei 2 weight portions
[claim 3] is characterized in that as pharmaceutical composition as described in the claim 2 Radix Et Rhizoma Rhei in the crude drug is a Radix et Rhizoma Rhei (processed).
The described preparation of drug combination method of [claim 4] claim 3 is characterized in that this method comprises following steps:
A) get Herba Epimedii and Radix et Rhizoma Rhei (processed), add 5-9 times of 60%-80% alcohol heating reflux respectively and extract 2-3 time, each 1-2 hour, filter, medicinal residues device are in addition preserved, and filtrate merges the back decompression recycling ethanol, and relative density is 1.30～1.35 extractum when being concentrated into 60 ℃, and is standby;
B) get that medicinal residues merge after the Radix Astragali, Herba Agrimoniae, Herba Leonuri, Fructus Lycii and the alcohol extraction, add 9-11 times of decocting respectively and boil 2-3 time, each 1-2 hour, filtration, merging filtrate, relative density is 1.30～1.35 extractum when being concentrated into 60 ℃, and is standby;
C) get the Colla Corii Asini molten, with the extractum mix homogeneously after above-mentioned alcohol extraction, the water boiling concentration;
D) the said mixture crushed after being dried is become fine powder.
[claim 5] is characterized in that as preparation of drug combination method as described in the claim 4 this method comprises following steps:
A) get Herba Epimedii and Radix et Rhizoma Rhei (processed), extract 3 times with 70% alcohol heating reflux, each alcohol adding amount is for being respectively 7,7,5 times, each return time each 1.5 hours, filter, medicinal residues device are in addition preserved, and filtrate merges the back decompression recycling ethanol, and relative density is 1.32～1.35 extractum when being concentrated into 60 ℃, and is standby;
B) get that medicinal residues merge after the Radix Astragali, Herba Agrimoniae, Herba Leonuri, Fructus Lycii and the alcohol extraction, decoct with water 2 times, amount of water is respectively 11 times, 9 times, decocting time each 1.5 hours filters merging filtrate, relative density is 1.32～1.35 extractum when being concentrated into 60 ℃, and is standby;
C) get the Colla Corii Asini molten, with the extractum mix homogeneously after above-mentioned alcohol extraction, the water boiling concentration;
D) with said mixture in 60 ℃ of drying under reduced pressure, be ground into fine powder.
[claim 6] is characterized in that the fine powder in the step d) is added granule adjuvant commonly used as preparation of drug combination method as described in claim 4 or 5, makes granule.
[claim 7] is as the application of pharmaceutical composition as described in the claim 3 in preparation treatment menopausal syndrome medicine.
Priority Applications (1)
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| CNB2004101554364A CN1283287C (en) | 2004-11-09 | 2004-11-09 | Pharmaceutical composition for treating climacteric syndrome and its preparing process |
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| CNB2004101554364A CN1283287C (en) | 2004-11-09 | 2004-11-09 | Pharmaceutical composition for treating climacteric syndrome and its preparing process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101461894B (en) * | 2007-12-20 | 2011-09-28 | 汉生堂药业有限公司 | Medicament composition for treating female climacteric syndrome and delaying age |
| CN102552545A (en) * | 2012-03-08 | 2012-07-11 | 李西秦 | New application of medicinal composition |
| CN101884698B (en) * | 2009-05-15 | 2012-07-25 | 天津太平洋制药有限公司 | Food therapy preparation for preventing and treating climacteric syndrome based on theories of preventive treatment of disease and medicine food homology |
-
2004
- 2004-11-09 CN CNB2004101554364A patent/CN1283287C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101461894B (en) * | 2007-12-20 | 2011-09-28 | 汉生堂药业有限公司 | Medicament composition for treating female climacteric syndrome and delaying age |
| CN101884698B (en) * | 2009-05-15 | 2012-07-25 | 天津太平洋制药有限公司 | Food therapy preparation for preventing and treating climacteric syndrome based on theories of preventive treatment of disease and medicine food homology |
| CN102552545A (en) * | 2012-03-08 | 2012-07-11 | 李西秦 | New application of medicinal composition |
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| Publication number | Publication date |
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| CN1283287C (en) | 2006-11-08 |
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