CN107007758A - It is a kind of for pharmaceutical composition of women's climacteric syndrome and its preparation method and application - Google Patents
It is a kind of for pharmaceutical composition of women's climacteric syndrome and its preparation method and application Download PDFInfo
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- CN107007758A CN107007758A CN201710380201.2A CN201710380201A CN107007758A CN 107007758 A CN107007758 A CN 107007758A CN 201710380201 A CN201710380201 A CN 201710380201A CN 107007758 A CN107007758 A CN 107007758A
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Abstract
The present invention discloses a kind of for pharmaceutical composition of women's climacteric syndrome and preparation method thereof, described pharmaceutical composition is made up of hypericum perforatum, wilsonii, agalloch eaglewood, santal, radix bupleuri, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetite, hand ginseng and arginine, glutamic acid, and preparation method includes the step such as volatile oil extracting and inclusion, water extraction, preparations shaping.Results of animal shows that pharmaceutical composition of the present invention can significantly improve the symptom of forced swimming and the disappointed experiment mice of outstanding tail；Clinical effectiveness shows that the pharmaceutical composition has preferable curative effect to climacteric metancholia of women, and curative effect is peaceful better than conventional treatment drug climacteric.
Description
Technical field
It is more particularly to a kind of comprehensive for treating Woman climacteric the present invention relates to a kind of pharmaceutical composition and preparation method thereof
Pharmaceutical composition of disease and preparation method thereof is closed, belongs to technical field of pharmaceuticals.
Background technology
Climacteric metancholia be women estrogen level decline cause psychology and physiology occur change caused by it is a series of
In symptom, traditional medicine, climacteric metancholia belongs to the category of " premenopausal rear all diseases ", and reason is mainly kidney qi exhaustion, and punching is appointed
Virtual loss, asthenia of essence and blood, menses is gradually exhausted, the menstruation physiological change that the menopause that arrives occurs by disconnected, yin and yang imbalance, internal organs qi and blood function
A series of syndrome for functions disorder lacked of proper care and occurred.The interpretation of the cause, onset and process of an illness being related to mainly has liver dysfunction, stagnation of QI due to depression of the liver, or spleen to lose
With the passing of time life in strong fortune, phlegm wet, or fat abundant expectoration, stagnation of QI due to depression of the liver cause qi stagnation blood stasis, phlegm accumulating with stagnant blood and be disease.Or the deficiency of the kidney yin,
Ji the heart-yin, or heart-fire hyperactivity can not be gone up, it is impossible under meet at kidney, make the fiery disequilibrium of heart kidney yin yang edema, form breakdown of the normal physiological coordination between the heart and the kidney.Thus
It can be seen that, the traditional Chinese medical science thinks that climacteric metancholia is deficiency of kidney-QI, so that what vital organs of the human body imbalance of yin and yang was caused, therefore in treatment,
With kidney tonifying gas, adjustment negative and positive are main method.
For the different interpretation of the cause, onset and process of an illness, the usual symptomatic treatment of the traditional Chinese medical science such as uses nourishing liver and kidney, nourishing yin and suppressing the excessive yang is controlled for the deficiency of liver-yin and kidney-yin
Method；For breakdown of the normal physiological coordination between the heart and the kidney, using nourishing Yin and falling fire, restoring normal coordination between heart and kidney therapy；Dispersing stagnated hepatoqi is used for stagnation of liver qi, clearing heat and nourishing yin is controlled
Method, etc., clinic has certain effect but effect and unstable.
The content of the invention
In order to overcome the defect of prior art, found by studying, hypericum perforatum can improve the depression of climacteric women
Shape, can not only improve psychology and physiological signs simultaneously, also contribute to the sexual function of climacteric women.Taking hypericum perforatum
After 12 weeks, the women for having 76% thinks that the menopausal syndrome symptom of oneself is obviously improved or disappeared.Hypericum perforatum and wilsonii
And arginine combination, then be equipped with it is other have one's ideas straightened out and drug for invigorating blood circulation and eliminating stasis, have preferable effect for climacteric metancholia.
It is an object of the present invention to provide a kind of pharmaceutical composition for women's climacteric syndrome.Technical scheme is such as
Under：
A kind of pharmaceutical composition for women's climacteric syndrome, is made up of the bulk drug of following parts by weight：Pass through leaf company
Stick up 40-120 parts, 60-240 parts of wilsonii, 15-50 parts of agalloch eaglewood, 15-50 parts of santal, 12-50 parts of radix bupleuri, 5-35 parts of cornu bubali, wheat
Winter 15-50 part, 10-20 parts of the wind-weed, 15-50 parts of cortex albiziae, 15-50 parts of jujube kernel, 12-40 parts of magnetite, hand join 15-100 parts, smart ammonia
Sour 1-20 parts, 1-20 parts of oryzanol.
According to currently preferred, the raw material medicines in portions by weight of described pharmaceutical composition is：60-100 parts of hypericum perforatum, thorn five
Plus 100-180 parts, 15-50 parts of agalloch eaglewood, 15-50 parts of santal, 20-50 parts of radix bupleuri, 15-30 parts of cornu bubali, tuber of dwarf lilyturf 20-50 part, know
Female 10-20 parts, 20-40 parts of cortex albiziae, 25-50 parts of jujube kernel, 20-40 parts of magnetite, 40-90 parts of hand ginseng, 1-8 parts of arginine, Gu Wei
It is plain 1-20 parts.
It is further preferred that the raw material medicines in portions by weight of described pharmaceutical composition is：80 parts of hypericum perforatum, 160 parts of wilsonii,
35 parts of agalloch eaglewood, 40 parts of santal, 40 parts of radix bupleuri, 20 parts of cornu bubali, 25 parts of the tuber of dwarf lilyturf, 15 parts of the wind-weed, 30 parts of cortex albiziae, 30 parts of jujube kernel,
30 parts of magnetite, 80 parts of hand ginseng, 3 parts of arginine, 12 parts of oryzanol.
It is a further object to provide the preparation side of the above-mentioned pharmaceutical composition for women's climacteric syndrome
Method, comprises the following steps：
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, by 3 taste medicinal material gross weights 4-12 extraordinarily
Water, using steam distillation, extracts volatile oil 3-7h, collects volatile oil, and decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to weight g/ volume ml percentages 3-7%, volatile oil
Envelope-bulk to weight ratio with beta-schardinger dextrin is 1ml：Under 3-10g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 3-6h, 0-4 DEG C
12-48h is refrigerated, suction filtration, precipitation, 40 DEG C of -60 DEG C of vacuum drying obtain volatile oil clathrate compound；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetic are taken by bulk drug composition and ratio
Stone, hand join totally 9 taste medicinal material, and the dregs of a decoction A extracted with step (1) after volatile oil is mixed, and the refluxing extraction that adds water 2-4 times adds water every time
Amount be 5-14 times of the 9 taste medicinal material and dregs of a decoction A gross weights, 1-4h is extracted every time, is filtered, volatile oil is extracted with step (1)
Extract solution A ' merging afterwards, is concentrated under reduced pressure, and is concentrated into the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40；Will stream
Extract dry, obtains extract B；
(3) extract B made from volatile oil clathrate compound made from above-mentioned steps (1), step (2) is mixed, adds formula
The arginine and oryzanol of amount, add customary adjuvant, and pharmaceutically acceptable any agent is prepared into according to common process
Type, including tablet, capsule, oral liquid, dripping pill, granule, condensed pill etc..
The auxiliary material includes solvent, diluent, disintegrant, flavouring, preservative, colouring agent, adhesive, lubricant, base
One or more of combinations in matter.
According to currently preferred, the preparation method of the above-mentioned pharmaceutical composition for women's climacteric syndrome, including
Following steps：
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, are added water by 10 times of 3 taste medicinal material gross weights,
Using steam distillation, volatile oil 4h is extracted, volatile oil is collected, decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to percent weight in volume 6%, volatile oil and β-ring
The envelope-bulk to weight ratio of dextrin is 1ml：Under 6g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 4h, 0-4 DEG C of refrigeration 24h, taken out
Filter, precipitation, 60 DEG C of vacuum drying obtain volatile oil clathrate compound；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetic are taken by bulk drug composition and ratio
Stone, hand join totally 9 taste medicinal material, and the dregs of a decoction A extracted with step (1) after volatile oil is mixed, and the refluxing extraction that adds water 2 times adds water twice
Amount is 8 times and 6 times of the 9 taste medicinal material and dregs of a decoction A gross weights respectively, and 2h is extracted every time, is filtered, and extracts and volatilizees with step (1)
Extract solution A ' merging after oil, is concentrated under reduced pressure, and is concentrated into the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40；Will
Liquid extract is dried, and obtains extract B；
(3) by extract B made from volatile oil clathrate compound made from above-mentioned steps (1), step (2) and formula essence used
Propylhomoserin, oryzanol are mixed, and the cornstarch of 20-40 parts by weight are added, using the ethanol of volumetric concentration 75% as wetting agent softwood, mistake
40 eye mesh screens are pelletized, and are put in 60 DEG C of baking ovens and are dried, and cross 40 eye mesh screen whole grains, encapsulated, are produced.
The relation of parts by weight and parts by volume of the present invention is g/ml or kg/l.
The medicine for the treatment of women's climacteric syndrome is being prepared it is also another object of the present invention to provide described pharmaceutical composition
Application in thing.
The invention has the advantages that：
1st, the invention provides a kind of pharmaceutical composition, composition include hypericum perforatum, wilsonii, agalloch eaglewood, santal, radix bupleuri,
Cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetite, hand ginseng, arginine, oryzanol etc..Found by clinical research, the group
Compound has good therapeutic effect to women's climacteric syndrome.
2nd, the present invention is extracted to the volatile oil component of prescription medicinal material, and uses beta-cyclodextrin inclusion compound technique, effectively
The stabilization that ensure that volatile oil effective component.
3rd, the present invention is extracted to medicinal material, is used as medicine with form of extract, passes through adding for modern granulation technique and lubricant
Enter, enhance mobility, it is possible to reduce loading amount error, improve the quality of the pharmaceutical preparations and production efficiency.
Embodiment
Following embodiments and experimental example are used to further illustrate but be not limited to the present invention.Medicine used in experimental example is
Medicament composition capsule for women's climacteric syndrome prepared by the embodiment of the present application 1.
Liuwei Dihuang Wan in experimental example as a comparison is commercially available prod.
It is embodiment 1, a kind of for medicament composition capsule of women's climacteric syndrome and preparation method thereof
Bulk drug is constituted：Hypericum perforatum 80g, wilsonii 160g, agalloch eaglewood 35g, santal 40g, radix bupleuri 40g, cornu bubali
20g, tuber of dwarf lilyturf 25g, wind-weed 15g, cortex albiziae 30g, jujube kernel 30g, magnetite 30g, hand ginseng 80g, arginine 3g, oryzanol 12g.
Preparation method：
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, are added water by 10 times of 3 taste medicinal material gross weights,
Using steam distillation, volatile oil 4h is extracted, volatile oil 4.2ml is obtained, decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to percent weight in volume 6%, volatile oil and β-ring
The envelope-bulk to weight ratio of dextrin is 1ml：Under 6g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 4h, 0-4 DEG C of refrigeration 24h, taken out
Filter, precipitation, 60 DEG C of vacuum drying obtain volatile oil clathrate compound 28.7g；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetic are taken by bulk drug composition and ratio
Stone, hand join totally 9 taste medicinal material, and the dregs of a decoction A extracted with step (1) after volatile oil is mixed, and the refluxing extraction that adds water 3 times adds water every time
Amount is 8 times of the 9 taste medicinal material and dregs of a decoction A gross weights, and 2h is extracted every time, filtration, and the extraction after volatile oil is extracted with step (1)
Liquid A ' merging, is concentrated under reduced pressure, and is concentrated into the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40；Liquid extract is done
It is dry, obtain extract B 66.4g；
(3) by the smart ammonia of extract B and formula ratio made from volatile oil clathrate compound made from above-mentioned steps (1), step (2)
Acid, oryzanol are mixed, and add 27g cornstarch, using the ethanol of volumetric concentration 75% as wetting agent softwood, cross 40 eye mesh screen systems
Grain, puts in 60 DEG C of baking ovens and dries, and crosses 40 eye mesh screen whole grains, encapsulated, produces.
It is embodiment 2, a kind of for pharmaceutical composition coating tablet of women's climacteric syndrome and preparation method thereof
Bulk drug is constituted：Hypericum perforatum 60g, wilsonii 180g, agalloch eaglewood 15g, santal 30g, radix bupleuri 20g, cornu bubali
15g, tuber of dwarf lilyturf 50g, wind-weed 10g, cortex albiziae 40g, jujube kernel 25g, magnetite 40g, hand ginseng 90g, arginine 1g, oryzanol 20g.
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, are added water by 4 times of 3 taste medicinal material gross weights,
Using steam distillation, volatile oil 7h is extracted, volatile oil 3.9ml is collected, decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to percent weight in volume 3%, volatile oil and β-ring
The envelope-bulk to weight ratio of dextrin is 1ml：Under 3g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 6h, 0-4 DEG C of refrigeration 12h, taken out
Filter, precipitation, 40 DEG C of -60 DEG C of vacuum drying obtain volatile oil clathrate compound 23.5g；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetic are taken by bulk drug composition and ratio
Stone, hand join totally 9 taste medicinal material, and the dregs of a decoction A extracted with step (1) after volatile oil is mixed, and the refluxing extraction that adds water 2 times adds water every time
Amount is 14 times of the 9 taste medicinal material and dregs of a decoction A gross weights, and 2h is extracted every time, filtration, and carrying after volatile oil is extracted with step (1)
Liquid A ' merging is taken, is concentrated under reduced pressure, the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40 is concentrated into；Liquid extract is done
It is dry, obtain extract B 62.7g；
(3) by extract B and arginine, Gu Wei made from volatile oil clathrate compound made from above-mentioned steps (1), step (2)
Element is mixed, and adds 40g cornstarch and other customary adjuvants, and piece agent is prepared according to common process, and film coating is produced.
It is embodiment 3, a kind of for medicament composition granule agent of women's climacteric syndrome and preparation method thereof
Bulk drug is constituted：Hypericum perforatum 40g, wilsonii 100g, agalloch eaglewood 30g, santal 15g, radix bupleuri 50g, cornu bubali
30g, tuber of dwarf lilyturf 20g, wind-weed 20g, cortex albiziae 20g, jujube kernel 50g, magnetite 20g, hand ginseng 40g, arginase 12 0g, oryzanol 1g.
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, are added water by 12 times of 3 taste medicinal material gross weights,
Using steam distillation, volatile oil 3h is extracted, volatile oil 4.1ml is obtained, decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to percent weight in volume 7%, volatile oil and β-ring
The envelope-bulk to weight ratio of dextrin is 1ml:Under 10g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 3h, 0-4 DEG C of refrigeration 48h, taken out
Filter, precipitation, 40 DEG C of -60 DEG C of vacuum drying obtain volatile oil clathrate compound 24.2g；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetic are taken by bulk drug composition and ratio
Stone, hand join totally 9 taste medicinal material, and the dregs of a decoction A extracted with step (1) after volatile oil is mixed, and the refluxing extraction that adds water 4 times adds water every time
Amount is 5 times of the 9 taste medicinal material and dregs of a decoction A gross weights, and 1h is extracted every time, filtration, and the extraction after volatile oil is extracted with step (1)
Liquid A ' merging, is concentrated under reduced pressure, and is concentrated into the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40；Liquid extract is done
It is dry, obtain extract B 58.5g；
(3) by extract B and arginine, Gu Wei made from volatile oil clathrate compound made from above-mentioned steps (1), step (2)
Element is mixed, and is added 20g cornstarch and other customary adjuvants, is prepared into granule according to common process, produces.
It is embodiment 4, a kind of for pharmaceutical composition condensed pill of women's climacteric syndrome and preparation method thereof
Bulk drug is constituted：Hypericum perforatum 120g, wilsonii 240g, agalloch eaglewood 50g, santal 15g, radix bupleuri 50g, cornu bubali
35g, tuber of dwarf lilyturf 50g, wind-weed 10g, cortex albiziae 50g, jujube kernel 50g, magnetite 12g, hand ginseng 100g, arginine 8g, oryzanol 20g.
Preparation method：
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, are added water by 12 times of 3 taste medicinal material gross weights,
Using steam distillation, volatile oil 3h is extracted, volatile oil 4.1ml is obtained, decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to percent weight in volume 7%, volatile oil and β-ring
The envelope-bulk to weight ratio of dextrin is 1ml:Under 10g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 3h, 0-4 DEG C of refrigeration 48h, taken out
Filter, precipitation, 40 DEG C of -60 DEG C of vacuum drying obtain volatile oil clathrate compound 24.0g；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetic are taken by bulk drug composition and ratio
Stone, hand join totally 9 taste medicinal material, and the dregs of a decoction A extracted with step (1) after volatile oil is mixed, and the refluxing extraction that adds water 4 times adds water every time
Amount is 5 times of the 9 taste medicinal material and dregs of a decoction A gross weights, and 1h is extracted every time, filtration, and the extraction after volatile oil is extracted with step (1)
Liquid A ' merging, is concentrated under reduced pressure, and is concentrated into the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40；Liquid extract is done
It is dry, obtain extract B 59.1g；
(3) by extract B and arginine, Gu Wei made from volatile oil clathrate compound made from above-mentioned steps (1), step (2)
Element is mixed, and is added customary adjuvant, is prepared into condensed pill according to common process, produces.
Experimental example 1, stability test
Using volatile oil as index, the stability of the pharmaceutical composition for women's climacteric syndrome is investigated.
Volatile oil is extracted as described in Example 1, and is included, and medicament composition capsule (inclusion sample) is further made；Press
Embodiment 1 obtains volatile oil with legal system, and after not including directly with 3 times of 85% alcohol dissolving sprinkling batch mixing, medicine group is further made
Compound capsule (does not include sample)；(40 DEG C ± 2 DEG C of temperature, the decentralization of relative humidity 75% ± 5%) is set to 0 identical conditions, 1,2,3,6
Month, volatile oil content is detected, 1 is the results are shown in Table.
Investigation result of the beta-cyclodextrin inclusion compound of table 1 to stability of volatile oil
As a result show, after volatile oil beta-cyclodextrin inclusion compound of the present invention, the stability of volatile oil in the formulation can be improved.
Experimental example 2, craft screening experiment
1st, extraction process optimization test
(1) experiment of different extraction times is investigated
Agalloch eaglewood, santal, 3 kinds of medicinal materials of radix bupleuri, plus 8 times of weight water are taken to extract volatile oil 5 hours by bulk drug proportioning, extraction is waved
The another device of extract solution after hair oil is preserved, extract the dregs of a decoction and hypericum perforatum after volatile oil, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed,
Totally 9 taste medicinal materials add water refluxing extraction 3 times for cortex albiziae, jujube kernel, magnetite, hand ginseng, and the amount added water every time is 8 times of weight, and volatile oil is carried
Liquid and first time aqueous extract is taken to merge, concentration determines dry spun and saponin content, second and third time aqueous extract is single respectively
Solely concentration, determines dry spun, saponin content.Result of the test is shown in Table 2.
The experiment of the different extraction times of table 2 is investigated
It can be seen from measurement result, by extract volatile oil after the dregs of a decoction merge with remaining medicinal material extract 2 times, 2 hours every time,
Its saponin extraction rate respectively more than 90% (it is 100% to extract saponin(e summation by 3 times), therefore is extracted 2 times, is extracted 2 hours every time
Extraction effect can be met.
(2) different extraction times
Agalloch eaglewood, santal, 3 kinds of medicinal materials of radix bupleuri, plus 8 times of weight water are taken to extract volatile oil 5 hours by bulk drug proportioning, extraction is waved
The another device of extract solution after hair oil is preserved, extract the dregs of a decoction and hypericum perforatum after volatile oil, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed,
Totally 9 taste medicinal materials add water refluxing extraction 2 times for cortex albiziae, jujube kernel, magnetite, hand ginseng, and the amount added water every time is 8 times of weight, extraction time
Extracted according to the extraction time being related in table 3, extract solution is merged respectively, concentrated, determine dry spun and saponin content.Measurement result
It is shown in Table 3.
The experiment of the different extraction times of table 3 is investigated
It can be seen from measurement result, paste-forming rate and saponin(e can increase with the extension of extraction time, and extraction time is 2
At+1 hour, saponin content is 3.84g, slightly smaller, during 2+2 and 2+3 hours extraction time, and paste-forming rate and saponin content are differed not
Greatly, therefore preferably extraction time is every time 2 hours.
(3) it is different to extract solvent consumption
Agalloch eaglewood, santal, 3 kinds of medicinal materials of radix bupleuri, plus 8 times of weight water are taken to extract volatile oil 5 hours by bulk drug proportioning, extraction is waved
The another device of extract solution after hair oil is preserved, extract the dregs of a decoction and hypericum perforatum after volatile oil, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed,
Totally 8 taste medicinal materials add water refluxing extraction 2 times for cortex albiziae, jujube kernel, magnetite, hand ginseng, extract 2 hours every time, the amount added water every time according to
The consumption designed in table 4 is extracted, and merges extract solution, and concentration determines dry spun and saponin content.Measurement result is shown in Table 4.
The experiment of the Different solution consumption of table 4 is investigated
It can be seen from measurement result, paste-forming rate and saponin content can increase, solvent amount with increasing for solvent is extracted
When being measured for 6+6 times, paste-forming rate and saponin content are all slightly smaller, the extraction of paste-forming rate and saponin content when extracted amount is 8+6 and 8+8
Amount difference is not very big, therefore preferred solvent amount of extracting is 8+6 times.
In summary, extraction process is preferably the refluxing extraction 2 times of adding water, and is extracted 2 hours every time, for the first time plus 8 times of amounts, the
Secondary plus 6 times of amounts.
Experimental example 3, hydroscopicity and mobility are investigated
(1) selection of auxiliary material prescription：It is auxiliary material to select microcrystalline cellulose, lactose, dextrin, cornstarch, and one is weighed by table 5
Pharmaceutical composition of the invention and auxiliary material prepared by quantitative embodiment 1, cross 80 mesh sieves and mix, put constant weight in drier, investigate
The hydroscopicity of pharmaceutical composition fine powder for women's climacteric syndrome prepared by embodiment 1 and angle of repose.
Compatibility prescription (the unit of the auxiliary material of table 5 and pharmaceutical composition：g)
(3) measure of hydroscopicity：The glass desicator that bottom is filled into sodium chloride supersaturated solution is put into 25 DEG C of constant temperature
Constant temperature 24h in incubator, now relative humidity is 75% in drier.It is put into thickness about 2mm's in the measuring cup bottom of constant weight
For the pharmaceutical composition medicinal powder of women's climacteric syndrome, the glass that sodium chloride supersaturated solution is placed in after correct amount is dried
In device (weigh the cap opening), in being kept in 25 DEG C of constant incubator, regularly weigh, hydroscopicity is calculated as follows：
Medicinal powder weight × 100% before hydroscopicity (%)=(medicinal powder weight before medicinal powder weight-moisture absorption after moisture absorption)/moisture absorption
It is grouped according to above-mentioned tested number, each operates parallel 2 parts, the results are shown in Table 6.
The hydroscopicity measurement result of table 6
From result, using hydroscopicity as index, it is preferred in various auxiliary materials with cornstarch and microcrystalline cellulose.
(4) angle of repose is determined：Using fixed funnel method, 3 funnels are connected and are fixed on the graph paper of horizontal positioned
At 1cm height, the pharmaceutical composition medicinal powder for women's climacteric syndrome that carefully different auxiliary material is made is respectively along leakage
Headwall is poured into uppermost funnel untill the medicinal powder cone tips of bottom funnel formation touch bell mouth, by sitting
Millimeter paper measures the diameter (surveying 6 times repeatedly) of conical base, calculates angle of repose, the results are shown in Table 7.
The angle of repose measurement result of the prescription medicinal powder of table 7
From result, using angle of repose as index, it is preferred with microcrystalline cellulose and cornstarch.
Summary result of the test, will make medicinal powder good fluidity, and hydroscopicity is low, production cost can be reduced again, then with corn
Starch is suitable.Therefore selection cornstarch is auxiliary material.
(5) particle using cornstarch as auxiliary material is compared with powder properties
1. the pharmaceutical composition 40g for women's climacteric syndrome that prepared by the method for Example 1, adds cornstarch
10g, using 75% ethanol as wetting agent softwood, crosses the granulation of 40 eye mesh screens, puts in 60 DEG C of baking ovens and dry, cross 40 eye mesh screen whole grains,
Produce composition grain.
2. the pharmaceutical composition 40g for women's climacteric syndrome that prepared by the method for Example 1, adds cornstarch
10g, is well mixed, and crosses 80 eye mesh screens, produces composition powder.
3. hydroscopicity is determined according to above-mentioned (3), determines angle of repose according to above-mentioned (4), the results are shown in Table 8.
The corn starch granules of table 8 and medicinal powder angle of repose and hydroscopicity measurement result
By above-mentioned results showed that so that cornstarch is auxiliary material and particle is made, the stability and stream of preparation can be improved
Dynamic property, is conducive to reducing the content uniformity in producing, improves the quality of the pharmaceutical preparations.
Experimental example 4, the improvement result to the disappointed depression model mouse of forced swimming and outstanding tail
First, Preparatory work of experiment
Male mouse of kunming, weight (20 ± 2) g, credit number:SCXK (Shandong) 2013-0002, by Shandong Shandong medicine
Limited company provides.Sample 1-4 (is prepared, wherein sample 1 is prepared for full formula by the method for embodiment 1；Sample 2 is to match somebody with somebody entirely
Side removes hypericum perforatum and prepared；Sample 3 is that full formula removes wilsonii preparation；Sample 4 is that full formula removes arginine and Gu Wei
Prepared by element).Positive control medicine fluoxetine hydrochloride dispersible tablet (Li Lai Suzhou pharmaceutical Co. Ltd, lot number：2842A, specification：
20mg).Electronic balance (AL104), Mettler-Toledo Instrument (Shanghai) Co., Ltd., Rotary Evaporators (RE-52C), Shanghai
Qingpu Hu Xi instrument plants.
2nd, experimental method
1st, packet and dosage
Mouse is grouped at random according to body weight, every group 10, is divided into blank group (giving same volume distilled water)；Positive drug group
(Fluoxetine hydrochloride group 20mg/kg)；Sample 1-4 groups.Gastric infusion, 1 time a day, successive administration 14d.Each group sample and positive drug
Finite concentration is dissolved into distilled water, so that it is 0.4ml/d that gavage amount is unified.
2nd, experimental implementation
A, forced swim test
Forced swim test (FST)：Mouse after 14d gavages 1h is placed in high 30cm, depth of water 10cm, diameter 15cm
In transparent cylindrical container, water temperature (25 ± 2) DEG C.Testing time is 6min, and preceding 2min is adaptation time, is arrived at timing 2min ends
6min end period in, test and assess mouse swimming behavior and motionless behavior, record mouse motionless behavior it is accumulative when
Between (second).So-called motionless behavior refers to：Mouse stops struggling in water, in floating state, except to avoid submerging in water, making
Head keeps keeping afloat the above, nostril surface and outside only tiny limb motion, without other motor behaviors.
B, outstanding tail disappointment experiment
Tail-suspention test (TST)：It is after mouse 14d administrations 1h, the tail end (at tail point 1cm) of mouse is solid with adhesive plaster
Live calmly, make mouse in the downward suspension status in head.It is separated between its head distance flat surface 15cm, every mouse with plate to regard
Line, it is to avoid mutual interference.Mouse can produce struggle activity to overcome abnormal position, but go out after movable a period of time
Existing motionless state, the desperate state of display.Motionless state is defined as：Mouse passive suspension, it is completely motionless.Tail-suspention test is carried out altogether
6min, preceding 2min be adaptation time, record from 2min end to 6min end totally 4 minutes section in motionless state it is accumulative when
Between (second).
It should be noted that experimental situation is tried one's best and kept quite in experiment, the interference to mouse is reduced；Kept in FST in water vat
Clarification of water is transparent；The depth of experiment reclaimed water is crucial, mouse rear solid end should be made just to touch cylinder bottom, but can not support body
Body.
3rd, experimental result and conclusion
Counted using spss17.0, as a result examined with t and carry out two group difference analyses.
1st, experimental result is shown in Table 9.
The forced swimming of table 9 and outstanding tail disappointed experiment mice dead time compare
Wherein, compared with blank group, * P ＜ 0.05, * * P ＜ 0.01
2nd, conclusion
Sample 1-4 has different degrees of shortening for the dead time of forced swimming and the disappointed experiment mice of outstanding tail, its
Middle full formula group (sample 1) effect is especially apparent, and the time shortens degree suitable with positive drug even better than positive drug, sample 2-4
Then have compared to sample 1 and be not so good as, show hypericum perforatum, wilsonii, arginine, oryzanol it is overall for depressed mouse have compared with
Important improvement therapeutic action.
Through mouse experiment, the preparation of embodiment 2~4 has reached the equivalent effect of above-mentioned 1 group of sample.
Experimental example 5, treatment climacteric metancholia clinical test
1. case diagnosis standard
Reference《Chinese medicine, natural drug treatment menopausal syndrome clinical test technological guidance's principle》And data of literatures
Formulate diagnostic criteria：
1. age 40~60 years old
2. menstruation menopause more than 3 months, hectic fever sweating is cardinal symptom；
3. can be with irritable, palpitation and insomnia, headache uncomfortable in chest, emotion-thought abnormal, failure of memory, fluctuation of blood pressure, waist-leg
Ache.
4. blood estradiol (estrodiol, E2)<30pg/ml, follicle-stimulating hormone (FSH) (Follicle Stimulating
Hormone, FSH)>10IU/L；
2. case inclusive criteria
(1) menopausal syndrome diagnostic criteria is met
(2) age 40-60 Sui
(3) Kupperman Index scorings are more than 15 points of persons
(4) patient voluntarily participates in research
3. case exclusion standard
(1) Western medicine diagnostic criteria is not met
(2) age<40 or>60 years old persons
(3) hypertension or Patients With Pheochromocytoma
(4) patients with hyperthyroidism
(5) mammography or Breast ultrasonography, find the patient of malignant breast tumor evidence
(6) uterus ultrasound diagnosis, finds uterine malignant tumour patient, endometrial hyperplasia patient
(7) mould or Bacterial leaf steak, urinary infection patient
(8) Bilateral oophorectomy, ovarian neoplasm and premature ovarian failure person
(9) allergic constitution or those who are allergic to this drug
(10) severe primary disease and the mental patients such as cardiovascular and the cerebrovascular, liver, kidney and hemopoietic system are merged
(11) estrogen and progestogen class medicine or similar Chinese medicine person are used
4. Dosing Regimens
Test 1 group of patient and take the complete square capsule of embodiment 1, once two grains, 3 times a day；Test 2 groups and take the method for embodiment 1
The full side prepared removes the capsule being made after wilsonii, once two grains, 3 times a day；It is peaceful that control group patient takes Tongrentang's board climacteric
(water-honeyed pill), 8 balls, 2 times a day；Warm water is oral.Continuous take 28 days is a course for the treatment of.
Patient takes similar or related drugs during taking medicine without must not agree to, must not use estrogen and progestational hormone medicine
Thing, no drinking is not smoked, and diet is preferably light.
5. testing program
The menopausal syndrome patient 180 of case inclusion criteria will be met, is randomly divided into 3 groups, respectively test 1 group,
Test 2 groups and control group, every group 60.Relative medicine treatment is taken according to Dosing Regimens regulation.Used before and after medication
Kupperman tables are scored
6. observation index
Scored before and after being taken medicine using the Kupperman point systems of country's improvement to patient, observation patient related symptoms,
Sign changes.Patient's hepatic and renal function is determined before and after medication.
7. the standard of curative effect evaluation
(1) Kupperman scoring deduction rate >=75% after recovery from illness treatment, symptom disappears；Drug withdrawal is not recurred in January；
(2) Kupperman scorings deduction rate >=50% after effective treatment, symptom largely disappears, and does not influence minimal invasive treatment
And work；
(3) Kupperman scorings deduction rate >=25% effectively after treatment, symptom small part disappears, and slightly influences minimal invasive treatment
And work；
(4) Kupperman scoring deduction rates ＜ 25% after futile treatment, symptom does not improve substantially, influences minimal invasive treatment
And work；
Note：Calculation formula (Nimodipine method) is：Integration × 100% before (being integrated before treatment after integration-treatment) ÷ treatments
8. result of the test
The composition capsule of 10 embodiment of table 1 treats (the %) ﹜ of Jie Guo ﹛ of menopausal syndrome
χ2Examine, * P are compared with control group<0.05
The above results are shown：Each group sample has certain curative effect to menopausal syndrome.60 patients of control group, cure rate
For 18.3%, obvious effective rate is 40%, and inefficiency is 26.7%, and total effective rate is 73.3%.It is 21.7% to test 1 group of cure rate,
Obvious effective rate is 46.7%, and inefficiency is 13.3%, and total effective rate is 86.7%；It is 15.0% to test 2 groups of cure rates, and obvious effective rate is
43.3%, inefficiency is 23.3%, and total effective rate is 76.7%.
Through χ2Examine, compared with control group, 1 group of total effective rate of experiment is significantly better than control group (P<0.05).Prompting is implemented
The complete square composition capsule treatment menopausal syndrome effect of example 1 is better than control sample；2 groups of total effective rates are tested with control group without aobvious
Write sex differernce, therapeutic equivalence (P ＞ 0.05).
In addition, two groups of patients are in drug administration process, obvious adverse reaction, the hepatic and renal function detection of medication Patients Before And After are had no
Index is in normal range (NR).
Claims (6)
1. a kind of pharmaceutical composition for women's climacteric syndrome, is characterised by, it is made up of the bulk drug of following parts by weight：
40-120 parts of hypericum perforatum, 60-240 parts of wilsonii, 15-50 parts of agalloch eaglewood, 15-50 parts of santal, 12-50 parts of radix bupleuri, cornu bubali 5-
35 parts, tuber of dwarf lilyturf 15-50 part, 10-20 parts of the wind-weed, 15-50 parts of cortex albiziae, 15-50 parts of jujube kernel, 12-40 parts of magnetite, hand ginseng 15-100
Part, 1-20 parts of arginine, 1-20 parts of oryzanol.
2. the pharmaceutical composition according to claim 1 for women's climacteric syndrome, is characterised by, by following weight
The bulk drug of part is made：60-100 parts of hypericum perforatum, 100-180 parts of wilsonii, 15-50 parts of agalloch eaglewood, 15-50 parts of santal, radix bupleuri
20-50 parts, 15-30 parts of cornu bubali, tuber of dwarf lilyturf 20-50 part, 10-20 parts of the wind-weed, 20-40 parts of cortex albiziae, 25-50 parts of jujube kernel, magnetite
20-40 parts, hand join 40-90 parts, 1-8 parts of arginine, 1-20 parts of oryzanol.
3. the pharmaceutical composition according to claim 1 for women's climacteric syndrome, is characterised by, by following weight
The bulk drug of part is made：80 parts of hypericum perforatum, 160 parts of wilsonii, 35 parts of agalloch eaglewood, 40 parts of santal, 40 parts of radix bupleuri, cornu bubali 20
Part, 25 parts of the tuber of dwarf lilyturf, 15 parts of the wind-weed, 30 parts of cortex albiziae, 30 parts of jujube kernel, 30 parts of magnetite, 80 parts of hand ginseng, 3 parts of arginine, oryzanol 12
Part.
4. the preparation method of the pharmaceutical composition for women's climacteric syndrome described in claim 1-3, it is characterised in that
Step is as follows：
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, adds water, adopt by 4-12 times of 3 taste medicinal material gross weights
With steam distillation, volatile oil 3-7h is extracted, volatile oil is collected, decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to percent weight in volume 3-7%, volatile oil is pasted with β-ring
The volume ml/ weight g ratios of essence are 1ml:Under 3-10g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 3-6h, 0-4 DEG C of refrigeration
12-48h, suction filtration, precipitation, 40 DEG C of -60 DEG C of vacuum drying obtain volatile oil clathrate compound；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetite, hand are taken by bulk drug composition and ratio
Join totally 9 taste medicinal material, the dregs of a decoction A extracted with step (1) after volatile oil is mixed, the refluxing extraction that adds water 2-4 times, the amount added water every time is
5-14 times of the 9 taste medicinal material and dregs of a decoction A gross weights, extracts 1-4h every time, filters, and carrying after volatile oil is extracted with step (1)
Liquid A ' merging is taken, is concentrated under reduced pressure, the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40 is concentrated into；Liquid extract is done
It is dry, obtain extract B；
(3) by the arginine of extract B and formula ratio made from volatile oil clathrate compound made from above-mentioned steps (1), step (2) and
Oryzanol, adds customary adjuvant, mixes, pharmaceutically acceptable any formulation is prepared into according to common process, including
Tablet, capsule, oral liquid, dripping pill, granule, condensed pill.
5. the preparation method of the pharmaceutical composition according to claim 4 for women's climacteric syndrome, its feature exists
In step is as follows：
(1) agalloch eaglewood, santal, the taste medicinal material of radix bupleuri 3 are taken by bulk drug composition and ratio, is added water by 10 times of 3 taste medicinal material gross weights, used
Steam distillation, extracts volatile oil 4h, collects volatile oil, and decoction filtration obtains extract solution A ' and dregs of a decoction A；
In the beta-schardinger dextrin saturated aqueous solution that gained volatile oil is added to percent weight in volume 6%, volatile oil and beta-schardinger dextrin
Envelope-bulk to weight ratio be 1ml：Under 6g, stirring condition, 40 DEG C -60 DEG C of keeping temperature stirs 4h, and 0-4 DEG C of refrigeration 24h, suction filtration sinks
Form sediment, 60 DEG C of vacuum drying obtain volatile oil clathrate compound；
(2) hypericum perforatum, wilsonii, cornu bubali, the tuber of dwarf lilyturf, the wind-weed, cortex albiziae, jujube kernel, magnetite, hand are taken by bulk drug composition and ratio
Join totally 9 taste medicinal material, the dregs of a decoction A extracted with step (1) after volatile oil is mixed, the refluxing extraction that adds water 2 times, the amount difference added water every time
It is 8 times and 6 times of the 9 taste medicinal material and dregs of a decoction A gross weights, 2h is extracted every time, filter, is extracted with step (1) after volatile oil
Extract solution A ' merging, is concentrated under reduced pressure, and is concentrated into the liquid extract that relative density under the conditions of 50-60 DEG C is 1.20-1.40；By liquid extract
Dry, obtain extract B；
(3) by extract B made from volatile oil clathrate compound made from above-mentioned steps (1), step (2) and formula smart ammonia used
Acid, oryzanol are mixed, and add the cornstarch of 20-40 parts by weight, using the ethanol of volumetric concentration 75% as wetting agent softwood, cross 40
Eye mesh screen is pelletized, and is put in 60 DEG C of baking ovens and is dried, and crosses 40 eye mesh screen whole grains, encapsulated, is produced.
6. the pharmaceutical composition for women's climacteric syndrome described in claim 1-3 is comprehensive in preparation treatment Woman climacteric
Close the application in the medicine of disease.
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| CN115554349A (en) * | 2022-11-03 | 2023-01-03 | 深圳太太药业有限公司 | Natural pharmaceutical composition for treating climacteric syndrome of women and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102600418A (en) * | 2012-03-29 | 2012-07-25 | 山东阿如拉药物研究开发有限公司 | Medicinal composition for treating female climacteric syndrome, and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102600418A (en) * | 2012-03-29 | 2012-07-25 | 山东阿如拉药物研究开发有限公司 | Medicinal composition for treating female climacteric syndrome, and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115554349A (en) * | 2022-11-03 | 2023-01-03 | 深圳太太药业有限公司 | Natural pharmaceutical composition for treating climacteric syndrome of women and application thereof |
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