CN108186779A - A kind of Chinese white poplar leaf flavonoids are dispelled pressure sore emulsifiable paste and its preparation process - Google Patents
A kind of Chinese white poplar leaf flavonoids are dispelled pressure sore emulsifiable paste and its preparation process Download PDFInfo
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Abstract
The invention belongs to technical field of traditional Chinese medicines, and in particular to a kind of Chinese white poplar leaf flavonoids are dispelled pressure sore emulsifiable paste and its preparation process.The present invention is for the flavone compound in Chinese white poplar leaf, and using 70% ethyl alcohol heating and refluxing extraction, D101 macroporous absorbent resins and polyamide are further detached, purified, and obtain Chinese white poplar leaf flavonoids, and be further made into emulsifiable paste.The Chinese white poplar leaf flavonoids and emulsifiable paste matrix hybrid process that the emulsifiable paste is matched by following parts by weight are made：0.4 10.0 parts of Chinese white poplar leaf flavonoids, 5.0 45.0 parts of water, 0.42 3.75 parts of glycerine, 0.94 8.43 parts of stearic acid, 0.08 0.75 parts of vaseline, 0.42 3.75 parts of lanolin, 0.44 3.98 parts of atoleine, 0.30 2.70 parts of glycerin monostearate, 0.1 0.9 parts of triethanolamine stearate soap.The drug has pressure sore good therapeutic effect.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, are related to a kind of medicinal external emulsifiable paste agent for treating wound, more particularly to a kind of hair
White poplar leaf flavonoids are dispelled pressure sore emulsifiable paste and its preparation process.
Background technology
Pressure sore is long-term bedridden patients, since physical extremely feeble or sensorimotor function are lost, no force transformation clinostatism,
In addition it is improper to nurse, and causes skin histology or even muscle between body surface bone knuckle and bedding, and because of continuous compression, part lacks
Oxygen, the ulcer that blood vessel embolism, tissue necrosis corruption take off and formed.Its forming process is divided into three phase of erythema phase, bubble phase and ulcerative stage.
Pressure sore incidence is up to 1-4.7%, has become a great problem in clinical nursing activity, and according to related document report, there are about 6 every year
Ten thousand people die of pressure sore complication.Pressure sore is considered as one of health problem that is current prominent and having negative effect, occurred frequently in sleeping
Bed the elderly, spinal cord injury, severe patient.Pressure sore incidence is 3-6% in the U.S., inpatient.China inpatient
Middle incidence is 3%-12%, and for the incidence of middle-older patient up to 10%-25%, the death rate increases by 6 times；In stupor, paraplegia disease
Incidence in people is 24%-48%；Incidence in patients with spinal cord injury is 25%-85%, and 8% is related with death.General doctor
Pressure sore incidence is 3%-14% in institute.Illness is not admitted to hospital and treats the pressure sore incidence of patient at home up to 50%.
Doctor trained in Western medicine is clinically mainly using III degree of antibiosis extract for treating or more pressure sore at present, as gentamicin, rifampin, chlorine are mould
Element, metronidazole etc., but the dosage of antibiotic externally treating pressure ulcer is difficult to control, and the patient of long-term illness is easily caused resistance to
The generation of medicine bacterium.Tcm clinical practice uses the compound of Chinese herbal medicine pressure sore of the putrefaction-removing granulation-promotings such as rheum officinale, dragon's blood, Asian puccoon, Cortex Phellodendri, the radix paeoniae rubrathe,
Such as moist exposed burn cream, jingwanhong soft plaster ointment, Yunnan Baiyao cream, these preparations do not have it is a being specific to pressure sore development, by
It is more more complicated than the pathogenesis of other ulcer in the pathogenesis of pressure sore, so clinical data is irregular the effect of display, treat
Effect quality is difficult to carry out unified evaluation.The state for the treatment of is given in current treatment still in doctor by experience.
Cream is meant outside the semisolid that drug, fine medicinal material powder, medicinal substances extract are mixed with suitable emulsion-type matrix
Use preparation.Dairy cow is widely used in external wounds, orthopaedics, ENT dept., anorectum department, dept. of dermatology and beauty etc., be through
Skin absorbs and generates a kind of Chinese medicine preparation of drug effect, it by the release of drug and can be both penetrated and into playing part in skin
Therapeutic effect can also enter body circulation to play systemic therapy effect by skin through capillary.In recent years, new Chinese medicine
Emulsifiable paste continuously emerges, and medicine-feeding technology and theoretical constantly improve, the research of this respect are just paid more and more attention.Chinese Pharmacopoeia 2015
It is provided under four general rule 0109 " ointment cream " items of version：Cream base should be uniform, fine and smooth, and being applied on skin or mucous membrane should
It is nonirritant；Cream can add in moisturizer, bacteriostatic agent, thickener, diluent, antioxidant and transdermal enhancer as needed；
Unless otherwise specified, the cream of bacteriostatic agent is added in when preparation determines prescription, and the inhibitory effect of the prescription should meet antibacterial effect
Power inspection technique（General rule 1121）Regulation；Cream should have appropriate stickiness, answer easy to apply on skin or mucous membrane, do not melt
Change, stickiness answers very little with seasonal variations；Cream should without rancid, foreign odor, change colour, be hardened iso-metamorphism phenomenon；Cream must not
There are water-oil separating and flatulence phenomenon.
Dried leaf of the Chinese white poplar leaf for Salicaceous Plants Chinese white poplar Pop μ lus tomentosa Garr., bitter, cold, nothing
Poison.Civil to be early documented with its water cooking liquid washout, the pressure sore of external application for curing oldness, curative effect obtains the accreditation of many doctors.
Modern pharmacodynamic study the result shows that, the Flavonoid substances in Chinese white poplar leaf have very strong antibacterial action.Clinic have much about
Chinese white poplar leaf is applied to the report of clinical treatment pressure sore, the results showed that the treatment pressure sore of Chinese white poplar leaf Aqueous extracts has good effect.
Related document report its to having the effect of fine using the still uncontrollable pressure sore of a large amount of antibiotic, wound healing after short 20d,
Color is white, flat.
Jiang Gaiying etc. treats Patients with Pressure Ulcers 36 in clinic using white Mao Yang leaf Aqueous extracts, pressure sore at totally 50, control group disease
People use the routine disinfection surface of a wound, thoroughly remove slough, manually biomembrane such as favour and health ulcer patch, pacify it is general patch etc., daily
Dressing is primary.Two groups pay attention to diligent turn while medication, keep skin cleaning drying.As a result treatment group's cure rate is
100%, and control group is only 33.3%, treatment group healing time 6.0d ± 1.5d, control group is 16.0d ± 1.5d, and two groups are compared,
Treatment group is substantially better than control group.The result shows that Chinese white poplar leaf is effective to I degree of-IV degree pressure sore, to skin not into ulcer
Healing is most fast, and 12-24h can fully recover（Ginger change English Poplar leaves treatment pressure sore clinical observation [J] home nurses, 2006,4
(10):15.）.Research shows that 70% alcohol extract of Chinese white poplar leaf has good antibacterial and anti-inflammatory and analgesic effect, these effects may be
Chinese white poplar treats the material base of pressure sore uniqueness curative effect.
Background technology is shown, although existing antimicrobial and biological membrane preparations have the effect of certain to treatment pressure sore, is treated
Effect is not notable, and adverse reaction is more；The treatment pressure sore of white Mao Yang leaf Aqueous extracts is significant in efficacy, but so far, does not carry out depth
Degree research and development, not yet succeed in developing curative for effect, quality controllable, safe to use pharmaceutical preparation, external application painting are particularly suitble to touch, sore
Ulcer position local administration, the cream dosage form to play a role conducive to drug absorption.
Invention content
For overcome the deficiencies in the prior art, of the invention first purpose is to provide a kind of Chinese white poplar leaf flavonoids and dispels pressure
Sore emulsifiable paste, the emulsifiable paste are externally used coating medicine, are that general flavone is extracted from Chinese white poplar leaf, add in the emulsifiable paste matrix for meeting medicinal requirements
And auxiliary material is processed into.It has the function of good treatment pressure sore.
Second purpose of the invention is to provide a kind of Chinese white poplar leaf flavonoids and dispels the preparation process of pressure sore emulsifiable paste, so that made
Chinese white poplar leaf flavonoids dispel pressure sore emulsifiable paste have the function of it is good treat pressure sore.
To achieve the above object, the technical solution adopted by the present invention is：A kind of Chinese white poplar leaf flavonoids are dispelled pressure sore emulsifiable paste,
The Chinese white poplar leaf flavonoids and emulsifiable paste matrix hybrid process matched by following parts by weight are made：Chinese white poplar leaf flavonoids
0.4-10.0 parts, 7.5-70.0 parts of emulsifiable paste matrix；
The Chinese white poplar leaf flavonoids are prepared by following technique：
S01. it extracts：Chinese white poplar leaf is taken, is crushed, 3-12 times is added in and measures 50%-90% ethanol solutions heating and refluxing extraction 1-4 times,
1-2 hours every time, merge extracting solution, 50 DEG C of heat are concentrated under reduced pressure into and survey the stream leaching that crude drug in whole 0.9-1.1g is equivalent to per ml concentrates
Cream, refrigeration are spare.
S02.D101 macroporous absorbent resins detach：The D101 macroporous absorbent resins of twice of applied sample amount is taken to be fitted into chromatographic column,
It is rinsed to eluent and clarified with 95% ethyl alcohol, then with distilled water flushing to no alcohol taste；Loading is slowly added dropwise, drop speed is 0.5 times of cylinder
Product/h suspends after end of the sample and rinses, standing adsorption 2 hours；It is eluted to distilled water colourless, discards eluent；It sequentially adds
20%th, 40%, 60% ethanol solution elute, be eluted to every time it is colourless, flow velocity be 10 times of column volume/h；Merge 20%, 40% ethyl alcohol
Solution elutes position, and reduced pressure is dried, crushed into fine powder, obtains 20%, 40% ethanol solution elution position powder.
S03. polyamide is taken to be heated to reflux 2h with 95% ethyl alcohol, is fitted into chromatographic column, with distilled water flushing to no alcohol
Taste；20%, 40% ethanol solution elution position powder is dissolved in suitable quantity of water, by applied sample amount:Polyamide amount is 1g:25ml, with
Loading is slowly added dropwise in 0.5 times of column volume/h drop speed, suspends after end of the sample and rinses, standing adsorption 2 hours；With distilled water flushing extremely
It is colourless, then colourless, collection eluent is eluted to 4 times of column volumes/h flow velocitys with 95% ethanol solution, reduced pressure, drying, i.e.,
Obtain Chinese white poplar leaf flavonoids.
Further, the emulsifiable paste matrix is any one in O/W types emulsifiable paste matrix, w/o type emulsifiable paste matrix.
Further, the emulsifiable paste matrix is O/W type emulsifiable paste matrixes, includes the component of following parts by weight：Water phase 5.4-48.8
Part, 2.1-19.8 parts of oil phase, 0.1-0.9 parts of w/o type emulsifiers.
Further, the water phase includes the ingredient of following parts by weight：5.0-45.0 parts of water, 0.42-3.75 parts of glycerine；It is described
Oil phase includes the ingredient of following parts by weight：0.94-8.43 parts of stearic acid, 0.08-0.75 parts of vaseline, lanolin 0.42-3.75
Part, 0.44-3.98 parts of atoleine, 0.30-2.70 parts of glycerin monostearate；The w/o types emulsifier is hard for triethanolamine
Resin acid soap.
In above-mentioned matrix formulations, 1 valency soap mainly is generated using triethanolamine and stearic acid, as O/W type emulsifiers, together
When using extra stearic acid as dispersed phase, increase the stickiness of emulsifiable paste matrix；Glycerine is mainly as moisturizer；Vaseline, liquid
Body paraffin is mainly used for adjusting the viscosity and stretchability of emulsifiable paste；Lanolin is mainly with the water imbibition for increasing matrix；Monostearate
Glyceride is weaker as a kind of emulsifying capacity, w/o type emulsifier function as co-emulsifiers.
Further, the Chinese white poplar leaf flavonoids and emulsifiable paste matrix hybrid process system that the emulsifiable paste is matched by following parts by weight
Into：2.0 parts of Chinese white poplar leaf flavonoids, 15.0 parts of water, 1.25 parts of glycerine, 2.81 parts of stearic acid, 0.25 part of vaseline, lanolin
1.25 parts, 1.33 parts of atoleine, 0.9 part of glycerin monostearate, 0.29 part of triethanolamine stearate soap.
Further, the triethanolamine stearate soap is by the triethanolamine of 0.1 parts by weight and the tristearin of 0.19 parts by weight
Acid stirs and evenly mixs, and reaction is made.
On this basis, further technical solution is：A kind of preparation process of Chinese white poplar leaf flavonoids, including walking as follows
Suddenly：
SA1. it extracts：Chinese white poplar leaf is taken, is crushed, 3-12 times is added in and measures 50%-90% ethanol solutions heating and refluxing extraction 1-4 times,
1-2 hours every time, merge extracting solution, 50 DEG C of heat are concentrated under reduced pressure into and survey the stream leaching that crude drug in whole 0.9-1.1g is equivalent to per ml concentrates
Cream, refrigeration are spare.
SA2.D101 macroporous absorbent resins detach：The D101 macroporous absorbent resins of twice of applied sample amount is taken to be fitted into chromatographic column,
It is rinsed to eluent and clarified with 95% ethyl alcohol, then with distilled water flushing to no alcohol taste；Loading is slowly added dropwise, drop speed is 0.5 times of cylinder
Product/h suspends after end of the sample and rinses, standing adsorption 2 hours；It is eluted to distilled water colourless, discards eluent；It sequentially adds
20%th, 40%, 60% ethanol solution elute, be eluted to every time it is colourless, flow velocity be 10 times of column volume/h；Merge 20%, 40% ethyl alcohol
Solution elutes position, and reduced pressure is dried, crushed into fine powder, obtains 20%, 40% ethanol solution elution position powder.
SA3. polyamide is taken to be heated to reflux 2h with 95% ethyl alcohol, is fitted into chromatographic column, with distilled water flushing to no alcohol
Taste；20%, 40% ethanol solution elution position powder is dissolved in suitable quantity of water, by applied sample amount:Polyamide amount is 1g:25ml, with
Loading is slowly added dropwise in 0.5 times of column volume/h drop speed, suspends after end of the sample and rinses, standing adsorption 2 hours；With distilled water flushing extremely
It is colourless, then colourless, collection eluent is eluted to 4 times of column volumes/h flow velocitys with 95% ethanol solution, reduced pressure, drying, i.e.,
Obtain Chinese white poplar leaf flavonoids.
Further, in step SA1, the condition of the reduced pressure is：Vacuum presses 0.075MPa ± 0.005MPa.
Further, in step SA3, the condition of the reduced pressure is：Vacuum presses 0.075MPa ± 0.005MPa；Decompression
Dry condition is temperature 60 C ± 5 DEG C, vacuum presses 0.065MPa ± 0.005MPa.
Further, the preparation process of the Chinese white poplar leaf flavonoids can be used for the preparation for the treatment of pressure sore drug.
On this basis, further technical solution is：A kind of Chinese white poplar leaf flavonoids are dispelled the preparation process of pressure sore emulsifiable paste,
Include the following steps：
SB1. the preparation of Chinese white poplar leaf flavonoids；
SB2. water phase, oil phase substrate, mixing for standby use are weighed respectively；Using emulsion process, w/o type emulsifier is added in into water phase, then add
Enter drug；
SB3. by water phase, oil phase is respectively placed in 80 DEG C of water-baths and melts, and water phase is slowly added into oil phase, stirring while adding to mixed
Close it is uniform, be cooled to room temperature under continuous stirring to get.
In step SB2, drug can be dissolved in hot water, so being added in water phase.
It in step SB3, needs to be cooled to room temperature under continuous stirring, main purpose ensures fully emulsified, prevents lotion
There is general sand, lamination.
The emulsifiable paste produced using this preparation process, lotion is homogeneous, smooth exquisiteness, applies on the skin without harsh feeling；Have
Appropriate vicidity and stretchability, are easy to be coated with；Preparation nature is stablized, it is no rancid, rotten phenomena such as；Nonirritant, anaphylaxis and
Other adverse reactions；It is easy to remove.
Beneficial effects of the present invention.
1st, the present invention after 70% ethyl alcohol heating and refluxing extraction, then distinguishes for the flavone compound in Chinese white poplar leaf
It is further detached, purified using D101 macroporous absorbent resins and polyamide, obtained Chinese white poplar leaf flavonoids；It is basic herein
On, emulsifiable paste is further made into, for treating pressure sore, and passes through pharmacodynamic experiment, it is always yellow to further demonstrate Chinese white poplar Ye
Ketone has pressure sore good therapeutic effect, and safety, non-evident effect is rapid-action, uneasy to recur, has to medicament research and development important
Meaning.
2nd, mostly because of patient's deficiency of qi and blood, gas does not transport blood for pressure sore, in addition caused by local compression, pain is not felt in affected part generally,
There is necrosis and festers gradually in first meeting redness purple plague purpura, and slough comes off, and forms ulcer, it is more difficult to heal.It should live to such chronic ulcer
Blood silt, the agent of putrefaction-removing granulation-promoting can prove effective.Flavone compound is mainly contained in Chinese white poplar leaf flavonoids prepared by the present invention.
Its flavone compound is bacteriostatic active ingredients, plays the role of anti-infective and helps muscle and skin growth.
3rd, Chinese white poplar is available anywhere in the north, and autumn picks up the leaf fallen, and winter uses, curative effect and fresh Poplar leaves without
Difference, to I degree-IV spend pressure sore it is effective, wherein skin is not most fast into the recovery from illness of ulcer, and 12h--24h can fully recover, medication into
This is cheap, economical and practical.
Specific embodiment
Technical scheme of the present invention is described in detail below, but present disclosure is not limited thereto.
Embodiment 1：
A kind of preparation process of Chinese white poplar leaf flavonoids, includes the following steps：
SA1. it extracts：Chinese white poplar leaf is taken, is crushed, 10 times is added in and measures 70% ethanol solution heating and refluxing extraction 3 times, 1.5 is small every time
When；Merge extracting solution, under the conditions of vacuum presses 0.075MPa ± 0.005MPa, 50 DEG C of heat surveys are concentrated under reduced pressure into, liquid phase is concentrated per ml
When in the liquid extract of crude drug in whole 1g, obtaining Chinese white poplar Leave extract, refrigeration is spare.
SA2.D101 macroporous absorbent resins detach：The D101 macroporous absorbent resins of twice of applied sample amount is taken to be fitted into chromatographic column,
It is rinsed to eluent and clarified with 95% ethyl alcohol, then with distilled water flushing to no alcohol taste；Loading is slowly added dropwise, drop speed is 0.5 times of cylinder
Product/h suspends after end of the sample and rinses, standing adsorption 2 hours；It is eluted to distilled water colourless, discards eluent；It sequentially adds
20%th, 40%, 60% ethanol solution elute, be eluted to every time it is colourless, flow velocity be 10 times of column volume/h；Merge 20%, 40% ethyl alcohol
Solution elutes position, and 50 DEG C of heat survey relative densities are concentrated under reduced pressure under the conditions of vacuum presses 0.075MPa ± 0.005MPa and are
The thick paste of 1.35-1.40g/ml is dried under reduced pressure, powder under the conditions of temperature 60 C ± 5 DEG C, vacuum pressure 0.065MPa ± 0.005MPa
Fine powder is broken into, obtains 20%, 40% ethanol solution elution position powder.
SA3. polyamide is taken to be heated to reflux 2h with 95% ethyl alcohol, is fitted into chromatographic column, with distilled water flushing to no alcohol
Taste；20%, 40% ethanol solution elution position powder is dissolved in suitable quantity of water, by applied sample amount:Polyamide amount is 1g:25ml, with
Loading is slowly added dropwise in 0.5 times of column volume/h drop speed, suspends after end of the sample and rinses, standing adsorption 2 hours；With distilled water flushing extremely
It is colourless, then colourless, collection eluent is eluted to 4 times of column volumes/h flow velocitys with 95% ethanol solution, reduced pressure, drying, i.e.,
Obtain Chinese white poplar leaf flavonoids.
1 key process parameter preferable case
It is yellow after testing in the preferred research process of technique according to a kind of preparation process of Chinese white poplar leaf flavonoids of the present embodiment
Ketones component enrichment condition is as a result as follows.
As shown in table 1, it is adsorbed through D101 macroporous absorbent resins, after 20% ethyl alcohol, 40% ethyl alcohol and 60% ethanol elution, wherein
20% ethyl alcohol and 40% alcohol elution general flavone content are higher, merge 20%, 40% ethanol solution elution position, so as to further
Purifying.
Determination of total flavonoids result after 1 D101 macroporous absorbent resin Chinese white poplar leaves difference of table elution position concentration, drying
。
Result of study shows that merging 20%, 40% ethanol solution elution position is reasonable.
As shown in table 2,20%, the 40% ethanol solution elution position of merging is adsorbed through polyamide, 95% ethanol elution
Afterwards, elution position general flavone content is up to more than 80%.
Determination of total flavonoids result after 2 polyamide Chinese white poplar leaf difference of table elution position concentration, drying
。
2 bacteriostatic tests
The Chinese white poplar leaf flavonoids that the Chinese white poplar Leave extract that step SA1 is obtained is obtained with SA3 carry out bacteriostatic test.
2.1 strain
The bacterial strain used is respectively staphylococcus aureus（Sa）, methicillin-resistant staphylococcus aureus（MRSA）, verdigris vacation
Monad（Pa）, proteus mirabilis（Pm）And escherichia coli（Ec）.These bacterial strains come from Affiliated Hospital of Ningxia Medical University
Microorganism preserves center.
2.2 method
2.2.1 paper disk method
The antibacterial activity of Chinese white poplar leaf flavonoids is tested by paper disk method.It will be per 0.1ml microbionations to corresponding agar culture
In base, it is uniformly mixed and pours into culture dish, culture medium in culture dish is made to cure in 30 minutes.Use various concentration（1-
256mg/ml；It is prepared by sterile water）Prepare Chinese white poplar leaf flavonoids（40μl）It is impregnated with the culture medium of drug, drying for standby.Sun
Property reference substance drug be minocycline（20141203,30 μ g/ pieces of lot number）, cefotaxime（20141203,30 μ g/ pieces of lot number）With
Erythromycin（20141203,15 μ g/ pieces of lot number）It is purchased from Hangzhou microorganism reagent company.The solid that the scraps of paper are adhered to inoculation is trained
After supporting on base, by them at 37 DEG C（MRSA is 35 DEG C）Middle culture 16 hours, record scraps of paper surrounding growth inhibit the diameter of circle.
2.2.2 minimal inhibitory concentration
With clinical and laboratory's standard common micro-dilution method M07-A8（CLSI, 2010）Determine Chinese white poplar leaf flavonoids to thin
The minimal inhibitory concentration of bacterium（MIC）.In 96 orifice plates Chinese white poplar leaf flavonoids are diluted to using sterile distilled water different dense
Degree.The adjustment of bacterium initial density is surveyed to the final inoculum concentrations of 105CFU/ml, 0.1ml bacterium are then added in into each hole of 96 orifice plates
Liquid.By 96 orifice plates at optimum conditions（Ec, Pa, Pm and Sa are 37 DEG C, and MRSA is 35 DEG C）It incubates 20 hours.After incubation, by MIC
It is defined as to inhibit bacteria the minimum concentration of growth, and the cell growth OD after cultivating 20 hours is measured by microplate reader
Value.Result of the test is determined with repeating the average value of experiment.
2.3 result
The bacteriostatic test result of 3 Chinese white poplar leaf flavonoids of table
Remarks：The microorganism used：Sa=staphylococcus aureus；MRSA=methicillin-resistant staphylococcus aureus；Pa =
Pseudomonas aeruginosa；Pm=proteus mirabilis；Ec=escherichia coli；-：Not after tested；no：Without activity.
The MIC value of 4 Chinese white poplar leaf flavonoids of table
Embodiment 2：
On the basis of embodiment 1, for a kind of Chinese white poplar leaf flavonoids obtained using embodiment 1 as raw material, addition meets medicinal want
The matrix asked, the cream being processed into.
A kind of Chinese white poplar leaf flavonoids are dispelled pressure sore emulsifiable paste, the Chinese white poplar leaf flavonoids and emulsifiable paste matched by following parts by weight
Matrix hybrid process is made：Chinese white poplar leaf flavonoids 2.0g, water 15.0g, glycerine 1.25g, stearic acid 3.0g, vaseline 0.25g,
Lanolin 1.25g, atoleine 1.33g, glycerin monostearate 0.9g, triethanolamine 0.1g.
The Chinese white poplar leaf flavonoids are dispelled the preparation process of pressure sore emulsifiable paste, are included the following steps：
SB1. the preparation of Chinese white poplar leaf flavonoids；
SB2. water phase, oil phase substrate, mixing for standby use are weighed respectively；0.1g triethanolamines and 0.19g stearic acid are weighed, stirring is mixed
It is even, it is added in water phase using emulsion process, adds drug；
SB3. by water phase, oil phase is respectively placed in 80 DEG C of water-baths and melts, and water phase is slowly added into oil phase, stirring while adding to mixed
Close it is uniform, be cooled to room temperature under continuous stirring to get.
A kind of Chinese white poplar leaf flavonoids of the present embodiment are dispelled pressure sore emulsifiable paste, combine the physiology of pressure sore, Pathologic Characteristics and
It is preferable to use w/o type matrix for pressure sore clinical treatment experience.Since main ingredient is water-soluble substances, therefore adds in appropriate lanolin and adjust medicine
Object solubility property.In order to find the optimum proportioning of each material of the emulsifiable paste matrix, screened using experiments of single factor, with centrifugation
Time, heat resistant test, low temperature resistant test are index, investigate emulsifiable paste matrix, emulsifier Adding Way, emulsifying temperature and drug and matrix
Influence of 4 factors of ratio to stability of cream.As a result it is as follows.
5 matrix formulations of table screen
Note："+" is general, and " ++ " is good.
Table 6 is heat-resisting, experiment of resisting cold
Note："-" is unchanged;"+" is thicker;" ++ " layering.
7 centrefuge experiment of table
Note："-" is unchanged;"+" is thicker;" ++ " layering.
Table 8 is heat-resisting, experiment of resisting cold
Note："-" is unchanged;"+" is thicker;" ++ " layering.
9 centrefuge experiment of table
Note："-" is unchanged;"+" is thicker;" ++ " layering.
To carrying out quality evaluation in terms of following 4 by Chinese white poplar leaf flavonoids manufactured in the present embodiment pressure sore emulsifiable paste of dispelling：
1. physical appearance：Observe color and luster whether uniformity, quality sophistication, no harsh feeling, no dirt；
2. acid-base property：Take sample that ethanol in proper amount is added to shake, the solution of gained is measured again with pH meter；
3. fusing point：General emulsifiable paste is convenient to approach the fusing point of vaseline, measures Chinese white poplar leaf flavonoids and dispels the heating of pressure sore emulsifiable paste
To temperature when oozing；
4. irritation：Normal mouse 5 is taken, 1cm is shaved off at back 22Hair, treat afterwards for 24 hours shaving generate stimulation fully recover from an illness
More after, emulsifiable paste is applied to shaving position, is observed and recorded afterwards for 24 hours.Daily coating is primary, continuous one week.Observe coating area skin
Surface should be normal, phenomena such as without rubescent, dermexanthesis, bubble.Mouse test is normal, you can carries out human trial, that is, takes white poplar leaf total
Flavones pressure sore emulsifiable paste of dispelling is coated in right amount on the inside of last arm, and whether observation abnormal response occurs for 24 hours.
Quality evaluation result is as follows：
1. physical appearance：Emulsifiable paste is rufous, and quality is fine and smooth, there is special aroma, no harsh feeling, no dirt；
2. acid-base value：Emulsifiable paste pH is 6.02, less than 8.5, is met the requirements；
3. fusing point：Emulsifiable paste fusing point is 44 DEG C, and fusing point meets the requirements close to vaseline fusing point；
4. irritation：Phenomena such as in mouse coating area skin one week without rubescent, dermexanthesis, bubble.Human trial does not occur not for 24 hours
Good reaction.
Meet Chinese Pharmacopoeia four general rules of version in 2015 by Chinese white poplar leaf flavonoids manufactured in the present embodiment pressure sore emulsifiable paste of dispelling
The pertinent regulations of cream under 0109 " ointment cream " item.
Embodiment 3：
On the basis of embodiment 2, pressure sore emulsifiable paste of dispelling to the Chinese white poplar leaf flavonoids obtained by embodiment 2 carries out pressure sore drug effect of dispelling
Learn experiment.
1 experiment material
1.1 reagents and drug
1.1.1 reagent
Chloraldurate；Vulcanized sodium.
1.1.2 drug
0.5% medical disinfectant tamed iodine, Shandong Lear health medical science and technology limited company, registration certificate number：Lu Wei, which disappears, demonstrate,proves word
（2002）No. 0059, lot number：20140105；Chinese white poplar leaf flavonoids are dispelled pressure sore emulsifiable paste, laboratory self-control, lot number：
20171112；Jingwanhong soft plaster ointment；Tianjin Darentang Wanhong Pharmaceutical Co., Ltd, authentication code：Chinese medicines quasi-word Z12020440,
Lot number：212021.
1.2 experimental animal
ICR mouse 30, half male and half female, quality 25-30g are provided by Ningxia Medical University's animal experimental center, and animal productiong is permitted
Number can be demonstrate,proved：SYXY（Rather）2015-0001.
Experimental method
It is prepared by 2.1 skin ulcer models
With 7% chloraldurate solution 0.005ml/g intraperitoneal injection of anesthesia during experiment, first hair is cut off roughly, then use in mouse back
8% sodium sulfide solution loses hair or feathers, iodophor disinfection, and about 2.4cm is cut off by center line of backbone in back Jin Jing sides2Round full thickness skin,
Stripping forms the Ulcer Models of defect to fascia.
2.2 dosage regimen
Mouse is randomly divided into 3 groups, every group 10.The model control group surface of a wound is not administered；Positive controls are applied with jingwanhong soft plaster ointment.
Experimental group smears Chinese white poplar leaf flavonoids and dispels pressure sore emulsifiable paste.
2.3 observation index
Ulcer surrounding skin growing state is observed, the ulcer area of skin is measured in the 0th, 3,4,5,6d（Picture is covered using film
Go out area, and the area of equal size is cut with pan paper, weigh and be converted into area）.
2.4 statistical method
With SPSS17.0 softwares, measurement data with（）It represents, using one-way analysis of variance, compares use two-by-two between group
LSD methods, P ＜ 0.05 are significant difference.
3 experimental results
10 each group surface of a wound area situation of table
Note：Compared with model control group, * P ﹤ 0.05；* P ﹤ 0.01
As seen from the results in Table 10, experimental group surface of a wound area is compared with model control group when testing the 3rd day, significant meaning（P ﹤
0.05）, prompt in the inflammatory reaction phase, each group is unfavorable to wound healing as foreign matter.It tests the 4th day and starts experimental group and the positive
Control group surface of a wound area is better than model control group, and surface of a wound area difference of 5d, 6d after modeling is significant（P<0.05）,
And experimental group and positive controls surface of a wound area discrepancy are meaningless（P>0.05).
The above is only presently preferred embodiments of the present invention, not to limit the present invention interest field.It is any with this
The technical solution or any those skilled in the art that the interest field that claim is covered is implemented, utilize
The method content of the disclosure above makes the scheme of many possible changes and modifications, all belongs to the scope of protection of the present invention.
Claims (10)
- The pressure sore emulsifiable paste 1. a kind of Chinese white poplar leaf flavonoids are dispelled, the Chinese white poplar leaf flavonoids and emulsifiable paste base matched by following parts by weight Matter hybrid process is made：0.4-10.0 parts of Chinese white poplar leaf flavonoids, 7.5-70.0 parts of emulsifiable paste matrix；The Chinese white poplar leaf flavonoids are prepared by following technique：S01. it extracts：Chinese white poplar leaf is taken, is crushed, 3-12 times is added in and measures 50%-90% ethanol solutions heating and refluxing extraction 1-4 times, 1-2 hours every time, merge extracting solution, 50 DEG C of heat are concentrated under reduced pressure into and survey the stream leaching that crude drug in whole 0.9-1.1g is equivalent to per ml concentrates Cream, refrigeration are spare；S02.D101 macroporous absorbent resins detach：The D101 macroporous absorbent resins of twice of applied sample amount is taken to be fitted into chromatographic column, with 95% Ethyl alcohol is rinsed to eluent and is clarified, then with distilled water flushing to no alcohol taste；Loading is slowly added dropwise, drop speed is 0.5 times of column volume/h, Suspend after end of the sample and rinse, standing adsorption 2 hours；It is eluted to distilled water colourless, discards eluent；Sequentially add 20%, 40%th, 60% ethanol solution elute, be eluted to every time it is colourless, flow velocity be 10 times of column volume/h；Merge 20%, 40% ethanol solution Position is eluted, reduced pressure is dried, crushed into fine powder, obtains 20%, 40% ethanol solution elution position powder；S03. polyamide is taken to be heated to reflux 2h with 95% ethyl alcohol, is fitted into chromatographic column, with distilled water flushing to no alcohol taste；It will 20%th, 40% ethanol solution elution position powder is dissolved in suitable quantity of water, by applied sample amount:Polyamide amount is 1g:25ml, with 0.5 times Loading is slowly added dropwise in column volume/h drop speed, suspends after end of the sample and rinses, standing adsorption 2 hours；With distilled water flushing to colourless, It is eluted to colourless, collection eluent with 4 times of column volumes/h flow velocitys with 95% ethanol solution again, is concentrated under reduced pressure, is dry to get hair White poplar leaf flavonoids.
- The pressure sore emulsifiable paste 2. a kind of Chinese white poplar leaf flavonoids as described in claim 1 are dispelled, it is characterised in that：The emulsifiable paste matrix is O/W type emulsifiable paste matrixes include the component of following parts by weight：5.4-48.8 parts of water phase, 2.1-19.8 parts of oil phase, w/o type emulsifiers 0.1-0.9 parts.
- The pressure sore emulsifiable paste 3. a kind of Chinese white poplar leaf flavonoids as claimed in claim 2 are dispelled, it is characterised in that：The water phase is included such as The ingredient of lower parts by weight：5.0-45.0 parts of water, 0.42-3.75 parts of glycerine；The oil phase includes the ingredient of following parts by weight：It is stearic 0.94-8.43 parts sour, 0.08-0.75 parts of vaseline, 0.42-3.75 parts of lanolin, 0.44-3.98 parts of atoleine, single tristearin 0.30-2.70 parts of acid glyceride；The w/o types emulsifier is triethanolamine stearate soap.
- The pressure sore emulsifiable paste 4. a kind of Chinese white poplar leaf flavonoids as claimed in claim 3 are dispelled, it is characterised in that：The emulsifiable paste is by as follows The Chinese white poplar leaf flavonoids and emulsifiable paste matrix hybrid process of parts by weight proportioning are made：2.0 parts of Chinese white poplar leaf flavonoids, water 15.0 Part, 1.25 parts of glycerine, 2.81 parts of stearic acid, 0.25 part of vaseline, 1.25 parts of lanolin, 1.33 parts of atoleine, monostearate 0.9 part of glyceride, 0.29 part of triethanolamine stearate soap.
- The pressure sore emulsifiable paste 5. a kind of Chinese white poplar leaf flavonoids as claimed in claim 4 are dispelled, it is characterised in that：The triethanolamine is hard Resin acid soap is stirred and evenly mixed by the triethanolamine of 0.1 parts by weight and the stearic acid of 0.19 parts by weight, and reaction is made.
- 6. a kind of preparation process of Chinese white poplar leaf flavonoids, includes the following steps：SA1. it extracts：Chinese white poplar leaf is taken, is crushed, 3-12 times is added in and measures 50%-90% ethanol solutions heating and refluxing extraction 1-4 times, 1-2 hours every time, merge extracting solution, 50 DEG C of heat are concentrated under reduced pressure into and survey the stream leaching that crude drug in whole 0.9-1.1g is equivalent to per ml concentrates Cream, refrigeration are spare；SA2.D101 macroporous absorbent resins detach：The D101 macroporous absorbent resins of twice of applied sample amount is taken to be fitted into chromatographic column, with 95% Ethyl alcohol is rinsed to eluent and is clarified, then with distilled water flushing to no alcohol taste；Loading is slowly added dropwise, drop speed is 0.5 times of column volume/h, Suspend after end of the sample and rinse, standing adsorption 2 hours；It is eluted to distilled water colourless, discards eluent；Sequentially add 20%, 40%th, 60% ethanol solution elute, be eluted to every time it is colourless, flow velocity be 10 times of column volume/h；Merge 20%, 40% ethanol solution Position is eluted, reduced pressure is dried, crushed into fine powder, obtains 20%, 40% ethanol solution elution position powder；SA3. polyamide is taken to be heated to reflux 2h with 95% ethyl alcohol, is fitted into chromatographic column, with distilled water flushing to no alcohol taste；It will 20%th, 40% ethanol solution elution position powder is dissolved in suitable quantity of water, by applied sample amount:Polyamide amount is 1g:25ml, with 0.5 times Loading is slowly added dropwise in column volume/h drop speed, suspends after end of the sample and rinses, standing adsorption 2 hours；With distilled water flushing to colourless, It is eluted to colourless, collection eluent with 4 times of column volumes/h flow velocitys with 95% ethanol solution again, is concentrated under reduced pressure, is dry to get hair White poplar leaf flavonoids.
- 7. a kind of preparation process of Chinese white poplar leaf flavonoids as claimed in claim 6, it is characterised in that：In step SA1, institute The condition for stating reduced pressure is：Vacuum presses 0.075MPa ± 0.005MPa.
- 8. a kind of preparation process of Chinese white poplar leaf flavonoids as claimed in claim 6, it is characterised in that：In step SA3, institute The condition for stating reduced pressure is：Vacuum presses 0.075MPa ± 0.005MPa；The condition being dried under reduced pressure is temperature 60 C ± 5 DEG C, very Pneumatics 0.065MPa ± 0.005MPa.
- 9. a kind of preparation process of Chinese white poplar leaf flavonoids as claimed in claim 6, it is characterised in that：The Chinese white poplar Ye is total The preparation process of flavones can be used for the preparation for the treatment of pressure sore drug.
- The preparation process of pressure sore emulsifiable paste 10. a kind of Chinese white poplar leaf flavonoids are dispelled, includes the following steps：SB1. the preparation of Chinese white poplar leaf flavonoids；SB2. water phase, oil phase substrate, mixing for standby use are weighed respectively；Using emulsion process, w/o type emulsifier is added in into water phase, then add Enter drug；SB3. by water phase, oil phase is respectively placed in 80 DEG C of water-baths and melts, and water phase is slowly added into oil phase, stirring while adding to mixed Close it is uniform, be cooled to room temperature under continuous stirring to get.
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| CN106511577A (en) * | 2015-09-10 | 2017-03-22 | 宁夏医科大学 | Preparation method of anti-microbial populus tomentosa leaf general flavones |
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| CN106511577A (en) * | 2015-09-10 | 2017-03-22 | 宁夏医科大学 | Preparation method of anti-microbial populus tomentosa leaf general flavones |
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| CN108997457A (en) * | 2018-07-10 | 2018-12-14 | 宁夏医科大学 | Galuteolin and Quercetin -3-o- β-glucopyranoside extracting method in Chinese white poplar leaf |
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