CN104055882B - This sub-denier hair growth promoter of compound recipe and preparation method thereof - Google Patents
This sub-denier hair growth promoter of compound recipe and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to hair growth promoter technical field, be this sub-denier hair growth promoter of a kind of compound recipe and preparation method thereof；This sub-denier hair growth promoter of this compound recipe, raw materials by weight portion includes Semen Nigellae 1 part, 0.5 part of Semen Persicae and Semen Granati 0.1 part.This sub-denier hair growth promoter of compound recipe of the present invention is all demonstrated by being better than the hair-growing effects of existing composite siyadan oil for promoting hair growth under normal model and pathological model, suitable with the hair-growing effects of street drug minoxidil or finasteride, illustrate that the hair-growing effects of this sub-denier hair growth promoter of compound recipe of the present invention is notable；Safety testing shows, this sub-denier hair growth promoter of compound recipe of the present invention does not shows skin irritation and anaphylaxis, illustrates that this sub-denier hair growth promoter of compound recipe of the present invention has higher safety；Medicinal residues can recycle simultaneously, improves resource utilization.
Description
Technical field
The present invention relates to hair growth promoter technical field, be this sub-denier hair growth promoter of a kind of compound recipe and preparation method thereof.
Background technology
Alopecia refer to hair pathologic come off and cause hair sparse or formed alopecia speckle, serious caused hair all takes off
Falling, pathogenic factor is unclear.Uygur's medical science is thought, alopecia refers to alopecia, occurs minimizing and scalp portion that speckle occurs suddenly
Shape alopecia is the disease of principal character, and complete taking off can be divided into take off two kinds with speckle, and the cause of disease is many to be affected by various inside and outsides undesirable element
Under, body fluid is unbalance, and makings is lacked of proper care, and is burnt lymphatic temperament and black gallbladder matter or strong bile matter and overrich corruption blood matter is condensed in skin
Skin or Rhizoma Imperatae, cause weakening of its local trophicity (absorbing power, take the photograph power and plastic force), affect caused by hair growth.
Alopecia is the commonly encountered diseases of department of dermatologry, frequently-occurring disease.In west, 30 years old male's sickness rate about 30%, 40 years old time be 40%,
It is 50% when 50 years old, and the white man at least 80% of 70 years old suffers from alopecia.In China, alopecia prevalence about 30.29%, wherein 25 years old extremely
In 55 years old male, 25% has androgenetic alopecia.Along with the increase of social pressure, alopecia is to the development that becomes younger, and patient groups
Rise year by year.Although the life of alopecia not entail dangers to people, but significantly affect attractive in appearance, to patient bring the biggest stress and
Psychological burden, particularly with the child of trophophase.
Over nearly 30 years, Bureau of Drugs Supervision of the U.S. only ratifies minoxidil and two kinds of hair growth medicines of finasteride.After approval
It is first-line drug always, Most patients is had preferable hair-growing effects.Two kinds of medicines, in long-term application, gradually expose one
Some not enough places, as, onset invalid to small part patient slowly, easily recurrence etc. after drug withdrawal.More allow patient perplexs is two kinds
Side effects of pharmaceutical drugs, minoxidil has phenomena of cutaneous irritation occurred frequently, and serious meeting causes palpitating speed, and blood pressure rises high secondary work
With, also have been reported that the unspecific allergic being still not clear with the cause effect relation used reacts such as welt, allergic rhinitis, face and swells
The untoward reaction such as swollen, allergy is breathed hard, had a headache, neuritis.Finasteride treatment androgenetic alopecia is only applicable to male patient, long
Phase takes common sexual dysfunction (sexual impotence, hyposexuality, defective ejaculation), breast uncomfortable (mammary gland increase, mammary gland pain) and skin
Rash, still has other untoward reaction to include: anaphylaxis and the testicular pains such as scratchiness, rubella and face lip swelling.Some patients
In the case of medication effect is dissatisfied, uses the hair transplantation operation of somewhat expensive, but hair transplantation is for head own
Sending out rare patient, operation is difficult to carry out, it is easy to the complication such as infection, epidermoid cyst occur, and outward appearance is the most unnatural.
Uygur's medicine has the history of more than 2000 year, has unique medicine theoretical system, in difficulties such as treatment dermatosiss
Miscellaneous diseases aspect shows unique characteristics, and is increasingly favored by people.This sub-denier hair oil of dimension recurrence due to taking drug side is that treatment is commonly used by the Uygur nationality
Alopecia agent, has long-term applicating history and records in " (Uigurs medicine divides Drug Standard of Ministry of Public Health of the Peoples Republic of China
Volume) " national drug standards.Composite siyadan oil for promoting hair growth by Semen Nigellae, Semen Persicae, Semen Granati three taste medical material according to 1:0.5:0.1
Prescription, takes oil through squeezing and makes.It is applied to outward disease sites, treats the diseases such as alopecia, alopecia areata, scalp itch.Clinic for many years should
With showing, this product has certain curative effect, has the highest popularity in Xinjiang region.
It is the most excellent that composite siyadan oil for promoting hair growth has long-term clinical practice history, special effect etc. as national medicine
Point, but there is also the problem that product basic research is the weakest, in place of exposing some shortcomings in production and application.
1. drug effect aspect: existing composite siyadan oil for promoting hair growth has certain curative effect, but still can not be equal to minoxidil and finasteride
U.S., if drug action can be improved further can preferably play its value.2. utilization of resources aspect: this sub-denier of existing compound recipe is raw
Hair oil preparation method is made for the squeezing of Semen Nigellae, Semen Persicae and Semen Granati three taste medical material is taken oil, and medical material is medicine after squeezing takes oil
Slag i.e. discards as refuse；As the very limited amount of Chinese crude drug of resource, this is a kind of more inefficient Utilizing Resource Pattern, important
, squeeze the active component that there is substantial amounts for the treatment of disease after taking oil in medicinal residues, if it is irrational for discarding as refuse, because of
This, the drug action and the raising resource utilization that increase existing composite siyadan oil for promoting hair growth become the difficult problem needing solution badly.
Summary of the invention
The invention provides this sub-denier hair growth promoter of a kind of compound recipe and preparation method thereof, overcome above-mentioned prior art no
Foot, it can effectively solve the problem that existing alopecia agent drug effect difference can not effectively utilize with medicinal residues.
One of technical scheme is realized by following measures: this sub-denier hair growth promoter of a kind of compound recipe, raw material
Include Semen Nigellae 1 part, 0.5 part of Semen Persicae and Semen Granati 0.1 part by weight.
Further optimization and/or improvements to foregoing invention technical scheme one of are presented herein below:
This sub-denier hair growth promoter of above-mentioned compound recipe obtains as follows: the first step, by the desired amount of Semen Nigellae, Semen Persicae and stone
Pomegranate squeezes, and obtains fatty contents and medicinal residues after squeezing；Second step, adds 8 based on raw material weight number in medicinal residues
Part extracting to the solvent of 15 parts, solvent is water or percent by volume is the ethanol water of 10% to 70%, extracts twice, often
Secondary Extracting temperature is 80 DEG C to 100 DEG C, and each extraction time is 0.5 hour to 2 hours, and after twice extraction, united extraction liquid obtains
Mixed extract；3rd step, mixed extract obtains concentrated solution after concentrating under reduced pressure, and concentrated solution is in the density that temperature is when 25 DEG C
For 1.05g/mL to 1.25g/mL；4th step, after fatty contents and concentrated solution are mixed, adds Tween 80 or polyoxyethylene
Obtain after 40 castor oil hydrogenated mixings this sub-denier hair growth promoter of compound recipe, Tween 80 or polyoxyethylene 40 castor oil hydrogenated compound recipe this
Weight/mass percentage composition in sub-denier hair growth promoter is 10% to 60%.
This sub-denier hair growth promoter of above-mentioned compound recipe obtains as follows: the first step, by the desired amount of Semen Nigellae, Semen Persicae and stone
The pomegranate ethanol water that percent by volume is 95% to 99% extracts, and Extracting temperature is 20 DEG C to 80 DEG C, extraction time
It is 0.5 hour to 2 hours, after extraction, obtains fatty contents and medicinal residues；Second step, adds based on raw material weight number in medicinal residues
The ethanol water that percent by volume is 30% entering 8 parts to 15 parts extracts, and extracts twice, and each Extracting temperature is 80 DEG C
To 100 DEG C, each extraction time is 0.5 hour to 2 hours, and after twice extraction, united extraction liquid obtains mixed extract；3rd
Step, mixed extract obtains concentrated solution after concentrating under reduced pressure, concentrated solution temperature be density when 25 DEG C be 1.05g/mL extremely
1.25g/mL；4th step, after fatty contents and concentrated solution are mixed, is answered after adding the mixing of Oleum Ricini poly-hydrocarbon oxygen ester 35
Fang Siya denier hair growth promoter, the Oleum Ricini poly-hydrocarbon oxygen ester 35 weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10% to 60%.
This sub-denier hair growth promoter of above-mentioned compound recipe obtains as follows: the first step, by the desired amount of Semen Nigellae, Semen Persicae and stone
Pomegranate obtains powder after pulverizing with pulverizer；Second step, is just adding 10 parts to 30 parts based on raw material weight number in the powder
Hexane extracts, and Extracting temperature is 20 DEG C to 80 DEG C, and extraction time is 0.5 hour to 1.5 hours, obtains normal hexane after extraction
Extracting solution and medicinal residues, hexane extract obtains fatty contents after concentrating under reduced pressure volatilization normal hexane；3rd step, by raw material weight
Amount number meter adds the water of 8 parts to 15 parts in medicinal residues, boils and extracts, extracts twice, and each extraction 0.5 hour is little to 2
Time, after twice extraction, united extraction liquid obtains mixed extract；4th step, mixed extract is concentrated after concentrating under reduced pressure
Liquid, concentrated solution temperature be density when 25 DEG C be 1.05g/mL to 1.25g/mL；5th step, fatty contents and concentrated solution
After mixing, after adding Labraso mixing, obtain this sub-denier hair growth promoter of compound recipe, the poly-second of caprylic capric two
Alcohol glyceride weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10% to 60%.
This sub-denier hair growth promoter of above-mentioned compound recipe obtains as follows: the first step, by the desired amount of Semen Nigellae, Semen Persicae and stone
Pomegranate obtains powder after pulverizing with pulverizer；Second step, powder CO2Supercritical extraction instrument extracts, and extracting pressure is 10
MPa to 70 MPa, extraction temperature are 20 DEG C to 60 DEG C, extraction time is 1 hour to 3 hours, obtain fatty contents after extraction
And medicinal residues；3rd step, adds the water of 8 parts to 15 parts based on raw material weight number in medicinal residues, boils and extract, extract two
Secondary, to extract 0.5 hour to 2 hours every time, after twice extraction, united extraction liquid obtains mixed extract；4th step, mixed extraction
Liquid obtains concentrated solution after concentrating under reduced pressure, concentrated solution temperature be density when 25 DEG C be 1.05g/mL to 1.25g/mL；5th
Step, after fatty contents and concentrated solution are mixed, adds 15-hydroxy polyethylene glycol stearate and is uniformly mixed so as to obtain this sub-denier of compound recipe
Hair growth promoter, 15-hydroxy polyethylene glycol stearate weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10% to 60%.
The pressure of above-mentioned concentrating under reduced pressure is-0.04MPa to-0.09MPa, and the temperature of concentrating under reduced pressure is 50 DEG C to 95 DEG C.
The two of technical scheme are realized by following measures: the preparation of this sub-denier hair growth promoter of a kind of compound recipe
Method, is carried out: the first step in the steps below, the desired amount of Semen Nigellae, Semen Persicae and Semen Granati is squeezed, obtains after squeezing
Fatty contents and medicinal residues；Second step, the solvent adding 8 parts to 15 parts based on raw material weight number in medicinal residues extracts,
Solvent is water or percent by volume is the ethanol water of 10% to 70%, extracts twice, each Extracting temperature be 80 DEG C to 100
DEG C, each extraction time is 0.5 hour to 2 hours, and after twice extraction, united extraction liquid obtains mixed extract；3rd step, mixed
Close extracting solution after concentrating under reduced pressure, obtain concentrated solution, concentrated solution temperature be density when 25 DEG C be 1.05g/mL to 1.25g/
mL；4th step, after fatty contents and concentrated solution are mixed, adds Tween 80 or the mixing of polyoxyethylene 40 castor oil hydrogenated
After obtain this sub-denier hair growth promoter of compound recipe, Tween 80 or the polyoxyethylene 40 castor oil hydrogenated matter in this sub-denier hair growth promoter of compound recipe
Amount percentage composition is 10% to 60%.
The three of technical scheme are realized by following measures: the preparation of this sub-denier hair growth promoter of a kind of compound recipe
Method, is carried out: the first step in the steps below, by the desired amount of Semen Nigellae, Semen Persicae and Semen Granati percent by volume be 95% to
The ethanol water of 99% extracts, and Extracting temperature is 20 DEG C to 80 DEG C, and extraction time is 0.5 hour to 2 hours, after extraction
Obtain fatty contents and medicinal residues；Second step, adds the percent by volume of 8 parts to 15 parts based on raw material weight number in medicinal residues
Be 30% ethanol water extract, extract twice, each Extracting temperature is 80 DEG C to 100 DEG C, and each extraction time is
0.5 hour to 2 hours, after twice extraction, united extraction liquid obtained mixed extract；3rd step, mixed extract is through concentrating under reduced pressure
After obtain concentrated solution, concentrated solution temperature be density when 25 DEG C be 1.05g/mL to 1.25g/mL；4th step, fat-soluble portion
Divide and after concentrated solution mixing, after adding the mixing of Oleum Ricini poly-hydrocarbon oxygen ester 35, obtain this sub-denier hair growth promoter of compound recipe, the poly-hydrocarbon of Oleum Ricini
The oxygen ester 35 weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10% to 60%.
The four of technical scheme are realized by following measures: the preparation of this sub-denier hair growth promoter of a kind of compound recipe
Method, is carried out: the first step in the steps below, obtains after the desired amount of Semen Nigellae, Semen Persicae and Semen Granati pulverizer being pulverized
Powder；Second step, the normal hexane adding 10 parts to 30 parts based on raw material weight number in the powder extracts, and Extracting temperature is
20 DEG C to 80 DEG C, extraction time is 0.5 hour to 1.5 hours, obtains hexane extract and medicinal residues, normal hexane extraction after extraction
Liquid obtains fatty contents after concentrating under reduced pressure volatilization normal hexane；3rd step, adds 8 parts based on raw material weight number in medicinal residues
To the water of 15 parts, boil and extract, extract twice, extract 0.5 hour to 2 hours, united extraction liquid after twice extraction every time
Obtain mixed extract；4th step, mixed extract obtains concentrated solution after concentrating under reduced pressure, and concentrated solution is when temperature is 25 DEG C
Density is 1.05g/mL to 1.25g/mL；5th step, after fatty contents and concentrated solution are mixed, adds the poly-second of caprylic capric
Obtaining this sub-denier hair growth promoter of compound recipe after the mixing of glycol glyceride, Labraso is at this sub-denier hair growth promoter of compound recipe
In weight/mass percentage composition be 10% to 60%.
The five of technical scheme are realized by following measures: the preparation of this sub-denier hair growth promoter of a kind of compound recipe
Method, is carried out: the first step in the steps below, obtains after the desired amount of Semen Nigellae, Semen Persicae and Semen Granati pulverizer being pulverized
Powder；Second step, powder CO2Supercritical extraction instrument extracts, and extracting pressure is 10 MPa to 70 MPa, extraction temperature is
20 DEG C to 60 DEG C, extraction time be 1 hour to 3 hours, obtain fatty contents and medicinal residues after extraction；3rd step, by raw material weight
Amount number meter adds the water of 8 parts to 15 parts in medicinal residues, boils and extracts, extracts twice, and each extraction 0.5 hour is little to 2
Time, after twice extraction, united extraction liquid obtains mixed extract；4th step, mixed extract is concentrated after concentrating under reduced pressure
Liquid, concentrated solution temperature be density when 25 DEG C be 1.05g/mL to 1.25g/mL；5th step, fatty contents and concentrated solution
After mixing, adding 15-hydroxy polyethylene glycol stearate and be uniformly mixed so as to obtain this sub-denier hair growth promoter of compound recipe, 15-hydroxy stearic acid gathers
Glycol ester weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10% to 60%.
This sub-denier hair growth promoter of compound recipe of the present invention is all demonstrated by being better than existing compound recipe under normal model and pathological model, and this is sub-
The hair-growing effects of denier hair oil, suitable with the hair-growing effects of street drug minoxidil or finasteride, compound recipe of the present invention is described
The hair-growing effects of this sub-denier hair growth promoter is notable；Safety testing shows, this sub-denier hair growth promoter of compound recipe of the present invention does not shows skin
Zest and anaphylaxis, illustrate that this sub-denier hair growth promoter of compound recipe of the present invention has higher safety；Medicinal residues can reclaim profit simultaneously
With, improve resource utilization.
Detailed description of the invention
The present invention is not limited by following embodiment, can determine specifically according to technical scheme and practical situation
Embodiment.
Embodiment 1, this sub-denier hair growth promoter of this compound recipe, raw materials by weight portion include Semen Nigellae 1 part, 0.5 part of Semen Persicae and
Semen Granati 0.1 part.
Embodiment 2, this sub-denier hair growth promoter of this compound recipe is obtained by following preparation method: the first step, by the desired amount of Nigella damascena L.
Son, Semen Persicae and Semen Granati squeeze, and obtain fatty contents and medicinal residues after squeezing；Second step, based on raw material weight number
Adding the solvent of 8 parts to 15 parts in medicinal residues to extract, solvent is water or percent by volume is the ethanol water of 10% to 70%,
Extracting twice, each Extracting temperature is 80 DEG C to 100 DEG C, and each extraction time is 0.5 hour to 2 hours, closes after twice extraction
And extracting solution obtains mixed extract；3rd step, mixed extract obtains concentrated solution after concentrating under reduced pressure, and concentrated solution in temperature is
Density when 25 DEG C is 1.05g/mL to 1.25g/mL；4th step, after fatty contents and concentrated solution are mixed, adds tween
80 or the mixing of polyoxyethylene 40 castor oil hydrogenated after obtain this sub-denier hair growth promoter of compound recipe, Tween 80 or polyoxyethylene 40 hydrogenate castor
Oleum Sesami weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10% to 60%.
Embodiment 3, this sub-denier hair growth promoter of this compound recipe is obtained by following preparation method: the first step, by the desired amount of Nigella damascena L.
Son, Semen Persicae and the ethanol water that Semen Granati percent by volume is 95% to 99% extract, Extracting temperature be 20 DEG C to 80
DEG C, extraction time is 0.5 hour to 2 hours, obtains fatty contents and medicinal residues after extraction；Second step, by raw material weight number
Meter adds the ethanol water that percent by volume is 30% of 8 parts to 15 parts in medicinal residues and extracts, and extracts twice, carries every time
Taking temperature is 80 DEG C to 100 DEG C, and each extraction time is 0.5 hour to 2 hours, and after twice extraction, united extraction liquid is mixed
Extracting solution；3rd step, mixed extract obtains concentrated solution after concentrating under reduced pressure, and concentrated solution is that density when 25 DEG C is in temperature
1.05g/mL to 1.25g/mL；4th step, after fatty contents and concentrated solution are mixed, adds Oleum Ricini poly-hydrocarbon oxygen ester 35 and mixes
Obtaining this sub-denier hair growth promoter of compound recipe after even, the Oleum Ricini poly-hydrocarbon oxygen ester 35 weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is
10% to 60%.
Embodiment 4, this sub-denier hair growth promoter of this compound recipe is obtained by following preparation method: the first step, by the desired amount of Nigella damascena L.
Son, Semen Persicae and Semen Granati pulverizer obtain powder after pulverizing；Second step, adds 10 parts based on raw material weight number in the powder
Extracting to the normal hexane of 30 parts, Extracting temperature is 20 DEG C to 80 DEG C, and extraction time is 0.5 hour to 1.5 hours, after extraction
Obtaining hexane extract and medicinal residues, hexane extract obtains fatty contents after concentrating under reduced pressure volatilization normal hexane；3rd
Step, adds the water of 8 parts to 15 parts based on raw material weight number in medicinal residues, boils and extract, extract twice, extract every time
0.5 hour to 2 hours, after twice extraction, united extraction liquid obtained mixed extract；4th step, mixed extract is through concentrating under reduced pressure
After obtain concentrated solution, concentrated solution temperature be density when 25 DEG C be 1.05g/mL to 1.25g/mL；5th step, fat-soluble portion
Divide and after concentrated solution mixing, after adding Labraso mixing, obtain this sub-denier hair growth promoter of compound recipe, sad
Capric acid polyethyleneglycol glyceride weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10% to 60%.The particle diameter of powder is 10
Mesh is to 40 mesh.
Embodiment 5, this sub-denier hair growth promoter of this compound recipe is obtained by following preparation method: the first step, by the desired amount of Nigella damascena L.
Son, Semen Persicae and Semen Granati pulverizer obtain powder after pulverizing；Second step, powder CO2Supercritical extraction instrument extracts, extraction
Pressure power is 10 MPa to 70 MPa, extraction temperature is 20 DEG C to 60 DEG C, extraction time be 1 hour to 3 hours, obtain after extraction
Fatty contents and medicinal residues；3rd step, adds the water of 8 parts to 15 parts based on raw material weight number in medicinal residues, boils and carry
Taking, extract twice, extract 0.5 hour to 2 hours every time, after twice extraction, united extraction liquid obtains mixed extract；4th step,
Mixed extract obtains concentrated solution after concentrating under reduced pressure, concentrated solution temperature be density when 25 DEG C be 1.05g/mL to 1.25g/
mL；5th step, after fatty contents and concentrated solution are mixed, adds 15-hydroxy polyethylene glycol stearate and is uniformly mixed so as to obtain multiple
Fang Siya denier hair growth promoter, 15-hydroxy polyethylene glycol stearate weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is 10%
To 60%.The particle diameter of powder is that 10 mesh are to 40 mesh.
Embodiment 6, as the optimization of above-described embodiment, in embodiment 6 pressure of concentrating under reduced pressure be-0.04MPa to-
0.09MPa, the temperature of concentrating under reduced pressure is 50 DEG C to 95 DEG C.
This sub-denier hair growth promoter of the compound recipe that the above embodiment of the present invention obtains carries out safety with existing composite siyadan oil for promoting hair growth
Property and Usefulness Pair ratio
1, pharmacodynamics test
This sub-denier hair growth promoter effect to depilation C57BL/6 mice of 1.1 compound recipes of the present invention
Male C57BL/6 mice (Shanghai Jie Sijie laboratory animal company limited, ticket number SCXK(Shanghai) 2012-
0006), 6 week old, hair is in resting stage (skin pinkiness), adapts to raise one week.Back Colophonium paraffin (1:1) takes off
Hair, is randomly divided into 7 groups, often group 10；Blank group, does not award any tested material；Adjuvant group, gives 70% ethanol, and each consumption is
0.1mL/ is only；Composite siyadan oil for promoting hair growth group, (lot number is 0131101, and Xinjiang is tieed up to give existing product composite siyadan oil for promoting hair growth
I your Pharmaceutical Co., Ltd), each dosage be 0.1mL/ only；This sub-denier hair growth promoter (low dosage) group of compound recipe of the present invention,
This sub-denier hair growth promoter (middle dosage) group of compound recipe of the present invention and this sub-denier hair growth promoter (high dose) group of compound recipe of the present invention, give the most every time
Dose is 0.05mL/, 0.1mL/ and 0.2mL/；Existing minoxidil tincture group, gives commercially available minoxidil tincture
(specification is 5%, and lot number is 131101, Wanma Pharmaceutical Co., Ltd., Zhejiang), each dosage is 0.1mL/.
Each group mice is administered once every day sooner or later, takes appropriate uniform application in epilating area, and continuous use to skin enters
Resting stage (observation terminal).Record every mice by entering the fringe time of trophophase resting stage and observing terminal time, in sight
Examine terminal time, mice break neck put to death, take the new piliation that back same area area is 2.5cm × 2.5cm, weigh.Statistics
Analyze each tested material convert mice time, observe terminal time and gross weight difference, the results are shown in Table 1.
Fringe time is the time being changed into trophophase resting stage, and the time is the shortest shows that inducing action is the strongest, promotes hair
The strongest to the transformation ability of trophophase.As shown in Table 1, this sub-denier hair growth promoter of compound recipe of the present invention and existing composite siyadan oil for promoting hair growth
Group compares, fringe time significantly shorten (P＜ 0.05), basically identical with minoxidil tincture group effect (P＞ 0.05).
Observing terminal time closely related with the time of anagen phase, time long hair growth time of healing is the longest, promotion
Growth is the strongest；Table 1 shows, in addition to existing composite siyadan oil for promoting hair growth group, remaining group compares with adjuvant group and blank group, sees
Examine terminal time all be considerably longer than adjuvant group (P＜ 0.05)；This sub-denier hair growth promoter (low dosage) group of compound recipe of the present invention, the present invention are multiple
There are increase trend Fang Siya denier hair growth promoter (middle dosage) group and this sub-denier hair growth promoter (high dose) group time of compound recipe of the present invention, but nothing
Significant difference (P＜ 0.05)；Each dosage group and existing minoxidil tincture group effect basically identical (P＞ 0.05), high dose
The group time be considerably longer than existing composite siyadan oil for promoting hair growth group (P＜ 0.05)；This sub-denier hair growth promoter (high agent of compound recipe the most of the present invention
Amount) the group time be longer than existing minoxidil tincture group (P＜ 0.05).
Gross weight index weigh hair growth quality condition, table 1 shows, test empty group and adjuvant group without significant difference,
In addition to existing composite siyadan oil for promoting hair growth group, remaining group compares with adjuvant group, observes gross weight and is all remarkably higher than adjuvant group/blank group
(P＜ 0.05)；This sub-denier hair growth promoter each dosage group of compound recipe of the present invention is above existing composite siyadan oil for promoting hair growth group hair weight,
With minoxidil tincture group effect indistinction (P＞ 0.05)；This sub-denier hair growth promoter each dosage group gross weight of compound recipe of the present invention is increase
Trend, but no difference of science of statistics (P＞ 0.05).
This sub-denier hair growth promoter effect to androgens psilosis model mice of 1.2 compound recipes of the present invention
6 week old male C57BL/6 mice (Shanghai Jie Sijie laboratory animal company limited, ticket number SCXK(Shanghai)
2012-0006), 18 g to 22g, it is randomly divided into 6 groups, often group 10；Sodium chloride solution group, awards 0.9% sodium chloride solution
(lot number is 20111202, Jiangsu Ya Bang Pharmaceutical Group Co., Ltd), every time to consumption be 0.1mL/ only；This sub-denier of existing compound recipe
Hair growth promoting line of oils, (lot number is 0131101, and Xinjiang Uygur Pharmaceutical Limited Liability is public to give commercially available prod composite siyadan oil for promoting hair growth
Department), each dosage is 0.1mL/；This sub-denier hair growth promoter (low dosage) group of compound recipe of the present invention, this sub-denier of compound recipe of the present invention are raw
Send out agent (middle dosage) group and this sub-denier hair growth promoter (high dose) group of compound recipe of the present invention, each dosage be respectively 0.05mL/ only,
0.1mL/ and 0.2mL/ only；Finasteride group, (lot number is 314322, Hangzhou Mo Shadong to give finasteride tablet aqueous suspension
Pharmaceutical Co. Ltd).
Each group mice each intramuscular injection 0.1mL Testosterone Propionate injection (Shanghai General Pharmaceutical Co., ltd.'s product, lot number
100602, specification 1 mL:25mg), every day 1 time, make androgenetic alopecia model；Finasteride tablet group, non-according to 0.17mg/kg
That male amine dosage gavage gives finasteride suspension, every day 1 time；Remaining group takes each sample uniform application in mouse back, often
Day is administered once sooner or later, successive administration 12 weeks；In observe terminal time, mice break neck put to death, clip agents area area is
The skin and hair of 2.5cm × 2.5cm, hair weight of weighing.Mice skin of unhairing shears shreds, and adds PBS tissue homogenate
Machine high-speed homogenization, homogenate is centrifuged 20min in 3000rpm, collects supernatant, measures dihydrotestosterone by test kit description
(DHT) content, each group mice is shown in Table 2 in observation terminal time gross weight measurement result.
As shown in Table 2, skin after mice gives existing composite siyadan oil for promoting hair growth and this sub-denier hair growth promoter of compound recipe of the present invention
Interior DHT content is remarkably decreased, and hair weight is high, have preferable anticreep effect (P＜ 0.05)；This sub-denier hair growth promoter of compound recipe of the present invention
Each dosage group reduce skin DHT and increase gross weight effect be superior to existing composite siyadan oil for promoting hair growth group (P＜ 0.05)；The present invention
This sub-denier hair growth promoter group of compound recipe is with dosage increase gross weight in being obviously enhanced (P ＜ 0.05), and in skin, DHT content is with dosage increase
Reduce；In this sub-denier hair growth promoter of compound recipe of the present invention high dose group and positive drug finasteride group effect close to (P＞ 0.05).
This sub-denier hair growth promoter effect to cyclophosphamide alopecia model mice of 1.3 compound recipes of the present invention
Male C57BL/6 mice (Shanghai Jie Sijie laboratory animal company limited, ticket number SCXK(Shanghai) 2012-
0006), 6 week old are to 8 week old, and hair is in resting stage (skin pinkiness), adapt to raise one week.With Colophonium paraffin (1:1)
Depilation, is randomly divided into 6 groups, often group 10；Adjuvant group, gives 70% ethanol, and each consumption is 0.1mL/；This Asia of existing compound recipe
Denier hair growth promoting line of oils, (lot number is 0131101, Xinjiang Uygur Pharmaceutical Limited Liability to give commercially available prod composite siyadan oil for promoting hair growth
Company), each dosage is 0.1mL/；This sub-denier hair growth promoter (low dosage) group of compound recipe of the present invention, this sub-denier of compound recipe of the present invention
Hair growth promoter (middle dosage) group and this sub-denier hair growth promoter (high dose) group of compound recipe of the present invention, each dosage be respectively 0.05mL/ only,
0.1mL/ and 0.2mL/ only；Ciclosporin group, give 0.5% ciclosporin 0.15mL/ only (chemical pharmacy company limited of Taishan City,
10% solution).
District's hair follicle of pulling off the feather of after mice epilation was changed to trophophase by resting stage, when before the epilating area hair close growth IV phase
Two, taking appropriate each tested material uniform application in epilating area, every day is administered once sooner or later, and continuous use to skin enters and stops
Phase (observation terminal).Each group mice disposably press 150mg/kg dosage intraperitoneal injection of cyclophosphamide (Jiangsu perseverance in time growing IV phase
Auspicious medicine limited company, lot number is 20100218,0.2g/ bottle).In time observing terminal, disconnected neck puts to death mice, takes back phase
With the new piliation that site area is 2.5cm × 2.5cm, weigh, the results are shown in Table 3.
Mouse hair follicles gives the growth that cyclophosphamide can stop hair when being in trophophase, gross weight can be remarkably decreased.By table 3
All can improve it can be seen that mice gives this sub-denier hair growth promoter of compound recipe of the present invention, existing composite siyadan oil for promoting hair growth and ciclosporin
New piliation amount, have preferable anticreep effect (P＜ 0.05)；This sub-denier hair growth promoter group of compound recipe of the present invention increases gross weight with dosage and increases
Adding, middle dosage group and high dose group effect are better than existing composite siyadan oil for promoting hair growth group, suitable with ciclosporin effect (P＜
0.05).
3 kinds of models are used to be studied for this sub-denier hair growth promoter drug action of thoroughly evaluating compound recipe of the present invention: just using
Often C57BL/6 mice Colophonium paraffin loses hair or feathers, and induces its hair to enter new growth cycle period, and this is sub-to investigate compound recipe of the present invention
The effect that it is grown by denier hair growth promoter.Result of the test shows that this sub-denier hair growth promoter of compound recipe of the present invention can shorten by resting stage to life
Long-term transformation, extends the trophophase time thus effectively increases new piliation weight；For investigating the effect under pathological model, build
Having found androgen depilation model and cyclophosphamide depilation model, this sub-denier hair growth promoter of compound recipe of the present invention is demonstrated by two kinds of pathology moulds
Suppression depilation under type and promotion hair growth effect；This sub-denier hair growth promoter of compound recipe of the present invention is totally in dose dependent, with agent
The increase drug action of amount strengthens, and effect is better than existing composite siyadan oil for promoting hair growth.
2, denier hair growth promoter safety evaluatio
This sub-denier hair growth promoter of compound recipe of the present invention, with reference to national drug safety evaluatio research regulation, uses rabbit to investigate skin
The zest of skin, utilizes Cavia porcellus to investigate its anaphylaxis to skin.
2.1 reagent
Composite siyadan oil for promoting hair growth, (lot number is 0131101, Xinjiang Uigur Pharmaceutical Co., Ltd.)；
This sub-denier hair growth promoter of compound recipe of the present invention；
0.9% sodium chloride solution, lot number is 20111202, Jiangsu Ya Bang Pharmaceutical Group Co., Ltd；
DNFB (DNCB), Tianjin recovery fine chemistry industry institute, lot number is 20091223；
2.2 animals and packet
(Qinglongshan animal reproduction field, Nanjing provides male New Zealand rabbit, and animal credit number is SCXK (Soviet Union) 2012-
0008), body weight 2.0 kg to 3.0kg, it is randomly divided into 0.9% sodium chloride solution group, this sub-denier hair growth promoter group of compound recipe of the present invention, shows
There are composite siyadan oil for promoting hair growth group, often group 5；24h before experiment, chooses lateral symmetry position in the middle part of spinal column, little with hair scissors
Heart unhairing, every side is 10cm × 10cm, and depilation position should be without erythema, edema and breakage.
Cavia porcellus (Qinglongshan animal reproduction field, Nanjing provides, and animal credit number is SCXK (Soviet Union) 2012-0008), body weight
250g to 300g, is randomly divided into 0.9% sodium chloride solution group, this sub-denier hair growth promoter group of compound recipe of the present invention, this sub-denier life of existing compound recipe
Hair oil group and DNFB positive controls, often group 6；24h before experiment, chooses lateral symmetry portion in the middle part of spinal column
Position, by the careful unhairing of hair scissors, every side is 3cm × 3cm, and depilation position should be without erythema, edema and breakage.
2.3 methods and result
2.3.1 single-dose irritation test
Consubstantiality left and right sides self-contrast method, every rabbit left dorsal is used to go to hair-fields to be coated with this sub-denier hair growth promoting of compound recipe of the present invention
Agent 0.5mL, right side goes to hair-fields to be coated with 0.9% sodium chloride solution 0.5mL as comparison, covers with antiseptic gauze after administration, and adhesive tape is solid
Fixed；After 4 hours, clean with warm water and remove residual smear, 1 hour, 24 hours, 48 hours and 72 little time-divisions after removing medicine
Not observing local response, result shows, the recipient site of each treated animal is all without the irritation such as erythema, edema, each dynamic in experiment
The general state of thing, behavior, sign normally, illustrate that this sub-denier hair growth promoter of compound recipe of the present invention is to no skin irritation.
Multiple dosing irritation test
Using consubstantiality left and right sides self-contrast method, often group rabbit left dorsal goes to hair-fields to be coated with each group of correspondence test medicine
0.5mL, right side goes to hair-fields to be coated with 0.9% sodium chloride solution 0.5 mL as comparison, covers with antiseptic gauze after administration, and adhesive tape is fixed；
Every day 2 times, the most each 1 time, each administration time is identical, smears 4 weeks continuously；In going of the 7th day, the 14th day and the 21st day every time
Except after medicine 1 hour, be administered every time before, and last medication removes after medicine 1 hour, 24 hours, 48 hours and 72 hours, sees
Examining and understand, this sub-denier hair growth promoter group of 0.9% sodium chloride solution group, compound recipe of the present invention and existing composite siyadan oil for promoting hair growth group have no
The irritation such as erythema, edema.The general state of each animal in experiment, behavior, sign are without exception；Compound recipe of the present invention is described, and this is sub-
Denier hair growth promoter is to skin multiple dosing nonirritant.
Skin allergy test
Sensitization contact: district's uniform application 0.9% chlorination of losing hair or feathers on the left of each group of Cavia porcellus respectively at the 0th day, the 7th day and 14 days
DNFB 0.5 mL/ of sodium solution, the corresponding test medicine of each group and 1% only, covers with antiseptic gauze after administration, glue
Band is fixing, every time contact 6 h；Excite contact: 14 d after last is administered, lose hair or feathers on the right side of guinea pig back district's uniform application 0.9%
This sub-denier hair growth promoter of sodium chloride solution, compound recipe of the present invention and 0.1% DNFB 0.5mL/ only, excite, 6 h
Rear removal tested material, observes at once, and again observes skin allergy situation in 24h, 48h, 72h；Result shows, 0.9% chlorine
Change sodium solution group, this sub-denier hair growth promoter group of compound recipe of the present invention and existing composite siyadan oil for promoting hair growth group and guinea pig skin be there are no water
The skin allergic reactions such as swollen, erythema, also have no that the whole body allergy phenomenons such as Experimental Asthma In Guinea-pigs, astasia or shock occur, i.e.
Without sensitization；Positive control 2, there is moderate erythema or edema phenomenon in 4-dinitro-chlorine group guinea pig skin, and sensitization rate is 100%.
This sub-denier hair growth promoter of compound recipe of the present invention does not shows skin irritation and anaphylaxis, from product prescription analysis, prescription
The drug effect of middle Semen Nigellae, Semen Persicae and Semen Granati relaxes, and does not have strong impulse and anaphylaxis, and prescription Chinese crude drug has more
The effect of protection resisting skin allergy；In this sub-denier hair growth promoter of compound recipe of the present invention, selected surfactant is also lived for non-ionic surface
Property agent, does not have the zest that conventional surfactants is common；Therefore, in experiment, this sub-denier hair growth promoter of compound recipe of the present invention has no
There is the dermoreaction such as redness, edema, illustrate that this sub-denier hair growth promoter of compound recipe of the present invention has higher safety.
In sum, this experiment uses this sub-denier hair growth promoter drug action of 3 kinds of model thoroughly evaluatings compound recipe of the present invention, knot
Fruit shows, this sub-denier hair growth promoter of compound recipe of the present invention is all demonstrated by being better than this sub-denier of existing compound recipe under normal model and pathological model
The hair-growing effects of hair oil, suitable with the hair-growing effects of street drug minoxidil or finasteride, illustrate compound recipe of the present invention this
The hair-growing effects of sub-denier hair growth promoter is notable；Safety testing shows, this sub-denier hair growth promoter of compound recipe of the present invention does not shows skin thorn
Swash property and anaphylaxis, illustrate that this sub-denier hair growth promoter of compound recipe of the present invention has higher safety；Medicinal residues can recycle simultaneously,
Improve resource utilization.
Above technical characteristic constitutes embodiments of the invention, and it has stronger adaptability and implementation result, can basis
It is actually needed the non-essential technical characteristic of increase and decrease, meets the demand of different situations.
Table 1 each tested material convert mice time, observe terminal time and gross weight (n=10,X± SD)
*Compare with adjuvant group/blank group,+Significant difference when comparing with existing composite siyadan oil for promoting hair growth group (P＜ 0.05)
Table 2 androgen model mice gross weight and DHT assay result (n=10,X± SD)
Note:*Compare with sodium chloride solution group,+Compare with existing composite siyadan oil for promoting hair growth group,△Compare with finasteride group
Time significant difference (P＜ 0.05)
Table 3 mice observe terminal time gross weight (n=10,X± SD)
Note:*Compare with adjuvant group,+Compare with existing composite siyadan oil for promoting hair growth group,△When comparing with ciclosporin group, difference shows
Write (P＜ 0.05)
Claims (4)
1. this sub-denier hair growth promoter of compound recipe, it is characterised in that raw materials by weight portion includes Semen Nigellae 1 part, 0.5 part of Semen Persicae
With Semen Granati 0.1 part；Wherein: this sub-denier hair growth promoter of this compound recipe obtains as follows: the first step, by the desired amount of Nigella damascena L.
Son, Semen Persicae and the ethanol water that Semen Granati percent by volume is 95% to 99% extract, Extracting temperature be 20 DEG C to 80
DEG C, extraction time is 0.5 hour to 2 hours, obtains fatty contents and medicinal residues after extraction；Second step, by raw material weight number
Meter adds the ethanol water that percent by volume is 30% of 8 parts to 15 parts in medicinal residues and extracts, and extracts twice, carries every time
Taking temperature is 80 DEG C to 100 DEG C, and each extraction time is 0.5 hour to 2 hours, and after twice extraction, united extraction liquid is mixed
Extracting solution；3rd step, mixed extract obtains concentrated solution after concentrating under reduced pressure, and concentrated solution is that density when 25 DEG C is in temperature
1.05g/mL to 1.25g/mL；4th step, after fatty contents and concentrated solution are mixed, adds Oleum Ricini poly-hydrocarbon oxygen ester 35 and mixes
Obtaining this sub-denier hair growth promoter of compound recipe after even, the Oleum Ricini poly-hydrocarbon oxygen ester 35 weight/mass percentage composition in this sub-denier hair growth promoter of compound recipe is
10% to 60%.
This sub-denier hair growth promoter of compound recipe the most according to claim 1, it is characterised in that the pressure of concentrating under reduced pressure is-0.04MPa
To-0.09MPa, the temperature of concentrating under reduced pressure is 50 DEG C to 95 DEG C.
3. the preparation method of this sub-denier hair growth promoter of compound recipe, it is characterised in that carry out in the steps below: raw materials by weight portion
Including Semen Nigellae 1 part, 0.5 part of Semen Persicae and Semen Granati 0.1 part；The preparation method of this sub-denier hair growth promoter of this compound recipe is as follows
Carry out: the first step, be the ethanol water of 95% to 99% by the desired amount of Semen Nigellae, Semen Persicae and Semen Granati percent by volume
Extracting, Extracting temperature is 20 DEG C to 80 DEG C, and extraction time is 0.5 hour to 2 hours, obtain after extraction fatty contents and
Medicinal residues；Second step, the ethanol that percent by volume is 30% adding 8 parts to 15 parts based on raw material weight number in medicinal residues is water-soluble
Liquid extracts, and extracts twice, and each Extracting temperature is 80 DEG C to 100 DEG C, and each extraction time is 0.5 hour to 2 hours, and two
After secondary extraction, united extraction liquid obtains mixed extract；3rd step, mixed extract obtains concentrated solution after concentrating under reduced pressure, concentrates
Liquid temperature be density when 25 DEG C be 1.05g/mL to 1.25g/mL；4th step, after fatty contents and concentrated solution are mixed,
Obtaining this sub-denier hair growth promoter of compound recipe after adding the mixing of Oleum Ricini poly-hydrocarbon oxygen ester 35, Oleum Ricini poly-hydrocarbon oxygen ester 35 is in this sub-denier of compound recipe
Weight/mass percentage composition in hair growth promoter is 10% to 60%.
The preparation method of this sub-denier hair growth promoter of compound recipe the most according to claim 3, it is characterised in that the pressure of concentrating under reduced pressure
For-0.04MPa to-0.09MPa, the temperature of concentrating under reduced pressure is 50 DEG C to 95 DEG C.
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