CN106511512A - Traditional Chinese medicine external-use gel and preparation method and application thereof - Google Patents
Traditional Chinese medicine external-use gel and preparation method and application thereof Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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Abstract
The invention relates to the field of traditional Chinese medicine, in particular to traditional Chinese medicine external-use gel and a preparation method and application thereof. The traditional Chinese medicine external-use gel is prepared from, by weight part, 0.2-0.8 part of rhizoma coptidis total alkaloids extract and rheum officinale alcohol extract, 0.2-0.8 part of borneol and 800-1,000 parts of waterborne gel matrix. The rhizoma coptidis total alkaloids extract is prepared from, by weight part, 6-14 parts of rhizoma coptidis, and the rheum officinale alcohol extract is prepared from, by weight part, 1-5 parts of rheum officinale. The components and ratio of the gel matrix are optimized, and the preparation has good viscosity, permeability and stability. The prepared gel is better in biocompatibility and more comfortable to use, and can relieve the adverse reaction of medicine. An advanced and reasonable extraction process is set up, the effective ingredients of rhizoma coptidis and rheum officinale are acquired to the maximum extent, impurities are removed, the volume and dosage of medicine are reduced, and compatibility of the gel and related auxiliary materials is promoted.
Description
Technical field
The present invention relates to Chinese medicine and pharmacy field, in particular to a kind of Chinese medicine external gel and its system for treating acne
Preparation Method.
Background technology
Acne, is the chronic inflammatory disease of a kind of hair follicle, sebaceous gland, is often apt to occur in face, cervical region and thoracic dorsal position, and clinic is with black
Head acne, pimple, pustule, tuberosity, cyst are major determinant, and severe patient can form cicatrix.Primary disease sickness rate is high, and more than 10 years old blue or green few
There are 90% acne that the different orders of severity occurred, and often recurrent exerbation in year, serious shadow is brought to patient's physical and mental health
Ring.The generation of acne is relevant with various internal and external factors, and inherited genetic factorss, spiritual emotion, diet, sleep, environment and skin care item etc. are
The state of an illness of acne can be affected and increase, female patient is also related to menstrual cycle.
Traditional Chinese Medicine acne is called " rosacea caused by lung-wind ".Understanding of the traditional Chinese medical science to acne, main duty in lung stomach, cause acne
Reason is, caused by wind and heat in the lung meridian is hindered in skin or because of surfeit delicious food, greasy, maror, taste intrinsic heat, damp and hot interior life, to fumigate
Form in face.
Effective Therapeutic Method is there is no to acne medically at present, mainly using west such as tetracycline, metronidazole, tretinoins
Medicine is treated, exist uncertain therapeutic efficacy cut, course for the treatment of length, large side effects, the easily defect such as recurrence.
Heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, the product of promoting flow of QI and blood are adopted external therapy of Chinese herb more, it is straight by the method such as putting, applying, wash, smoke on the skin
Connect and act on affected part, safety is higher.DIANDAO SAN is derived from《Yizong Jinjian surgery heart method gist》, by equivalent sulfur, Radix Et Rhizoma Rhei
Composition, the effect of invigorating blood circulation with removing blood stasis with potent drugs, remove grease, is Chinese traditional treatment acne, seborrheic dermatitis, Seborrhea, rosacea
Classical external recipe, but its dosage form is more original, using inconvenience, is unfavorable for clinically extensive popularization and application.
In view of this, it is special to propose the present invention.
The content of the invention
The first object of the present invention is to provide a kind of Chinese medicine external gel, and described Chinese medicine external gel is not only in treatment
Better efficacy when acne, rosacea, Seborrhea and seborrheic dermatitis, and there is good absorbing, easy to use, safe non-stimulated
The advantages of.
The second object of the present invention is to provide a kind of preparation method of described Chinese medicine external gel, the method operation letter
Single, it is easy to grasp, convenient dissolving various composition is adapted to batch production and is widely applied.
In order to realize the above-mentioned purpose of the present invention, spy employs the following technical solutions：
A kind of Chinese medicine external gel, by weight, the Chinese medicine external gel includes following component：
Coptis total alkaloid extract, rheum offcinale, 0.2～0.8 part of sulfur, 0.2～0.8 part of Borneolum Syntheticum and aqueouss are coagulated
800～1000 parts of gel matrix；
In terms of the weight portion of material component, the coptis total alkaloid extract is obtained for 6～14 parts by Rhizoma Coptidis, the Radix Et Rhizoma Rhei
Ethanol extract is obtained for 1～5 part by Radix Et Rhizoma Rhei.
Preferably, Chinese medicine external gel as above, by weight, the Chinese medicine external gel is included with the following group
Part：
Coptis total alkaloid extract, rheum offcinale, 0.3～0.7 part of sulfur, 0.3～0.7 part of Borneolum Syntheticum and aqueouss are coagulated
820～990 parts of gel matrix；
In terms of the weight portion of material component, the coptis total alkaloid extract is obtained for 8～12 parts by Rhizoma Coptidis, the Radix Et Rhizoma Rhei
Ethanol extract is obtained for 2～4 parts by Radix Et Rhizoma Rhei.
Rhizoma Coptidis (Coptidis Rhizoma) bitter in the mouth cold in nature, GUIXIN, liver, spleen, gallbladder, stomach, large intestine channel.There is heat clearing and damp drying, rush down
The effect of fire removing toxic substances.External treatment eczema, eczema, auditory meatus are suppurated.
Radix Et Rhizoma Rhei (Rhei Radix et Rhizoma) bitter in the mouth cold in nature, Return liver, spleen, stomach, large intestine, pericardium channel.External has heat clearing away
Removing toxic substances, dispel silt, removing heat from blood the effects such as.
Sulfur (Sulfur) sour in the mouth, it is warm in nature, return kidney, large intestine channel.External removing toxic substances parasite killing treats skin ulcer, for scabies, tinea alba, carbuncle of yin nature
Malignant boil；After contacting with skin secretion, there is softening epidermis and kill dermatophytic effect.
Borneolum Syntheticum (Borneolum Syntheticum) acrid in the mouth, hardship, cool in nature, enter the heart, spleen, lung meridian；Inducing resuscitation of having one's ideas straightened out, heat clearing away are stopped
Bitterly.For sore swell and ache curative, symptom is not held back etc. after bursting, has cooling effect, fire removing toxic substances, waking up the patient from unconsciousness by clearing away heat can be dissipated.
Each taste Chinese medicine reasonable compatibility is had obvious inhibitory action to pathogenic bacterium such as propionibacterium acness by the present invention.
Preferably, Chinese medicine external gel as above, by weight, the aqueous gel substrate includes polyvinyl alcohol
40～60 parts of 05-88,4～6 parts of Acritamer 940,80～120 parts of Propylene Glycol, 80～120 parts of glycerol, triethanolamine 6.4～
600～660 parts of 9.6 parts, 8～12 parts of Tween-80 and distilled water.
Gel be by medicine with it is substrate composed, substrate is both the carrier of medicine, at the same also the release of medicine is had weight
The impact wanted, therefore, the selection of substrate is particularly important to preparing for gel.Gel can be divided into aqueouss according to the difference of substrate
Gel and oil-base gel agent.Aqueous gel has comfortable attractive in appearance, use, bioavailability height, good stability, untoward reaction
Less, the advantages of not polluting clothing, therefore more suitable for Chinese medicine external gel.
Index of the present invention with viscosity, filming performance and effective ingredient rate of release etc. alternatively, preferred Acritamer 940
With PVA as gel main matrix；Carbomer has certain toleration to acid, alkali, alcohol；It is resistant to low temperature storage
Deposit and high pressure moist heat sterilization, have good biocompatibility, eye and skin are not stimulated；Polyvinyl alcohol have it is nontoxic, harmless,
Colourless advantage, and its mechanical property, biocompatibility and hydrophilic are very suitable for gel provided by the present invention.
Propylene Glycol is not only one of composition of gel-type vehicle, the also function with Percutaneous absorption enhancer；
On the basis of above-mentioned substrate, the present invention again according to the preferred of the cumulative release amount and rate of release of total alkaloidss,
Determine the consumption of pH adjusting agent triethanolamine, wetting agent glycerol and emulsifying agent Tween-80 in formula.
Preferably, Chinese medicine external gel as above, ethanol of the Chinese medicine external gel also including 68%～72%
15～25 parts and 0.9～1.3 part of sterilization antiseptic.
Preferably, Chinese medicine external gel as above, the sterilization antiseptic are ethyl hydroxybenzoate.
Gel made by carbomer substrate need to generally add preservative, suppression of the ethyl hydroxybenzoate selected by the present invention to funguses
Bacterium effect is stronger.
Preferably, Chinese medicine external gel as above, the coptis total alkaloid extract and rheum offcinale be by
Rhizoma Coptidis and Radix Et Rhizoma Rhei pass through alcohol steep, concentration, obtain after purification.
Preferably, Chinese medicine external gel as above, the extraction process of the coptis total alkaloid extract are specifically wrapped
Include：
After Rhizoma Coptidis decoction pieces are with 68%～72% ethanol immersion 50min～70min, carried with 68%～72% alcohol reflux
Take twice, first time 80min～100min, second 50min～70min, the usage amount of 68%～72% ethanol is pressed every time
Solid-to-liquid ratio is 1g crude drugs：The ratio addition of the ethanol of 10mL～14mL 68%～72%；
The solution that alcohol steep is obtained is concentrated into into every milliliter of medicinal liquid comprising crude drug 0.3g～0.5g, Rhizoma Coptidis alcohol extraction is obtained
Liquid.
Preferably, Chinese medicine external gel as above, is concentrated into every milliliter of medicinal liquid equivalent to crude drug in the alcohol extract
After 0.3g～0.5g, also include：
Add while hot and account for the Sodium Chloride of medicine liquid volume 13%～17%, be stirred to dissolve, put to room temperature cold preservation 20h～
Take out after 28h and filter, obtain coptis total alkaloid extract.
Preferably, Chinese medicine external gel as above, the extraction process of the rheum offcinale are specifically included：
Radix Et Rhizoma Rhei decoction piece with 68%～72% ethanol immersion 100min～140min, 70% alcohol reflux twice, often
Secondary 50min～70min, the usage amount of 70% ethanol is 1g crude drugs by solid-to-liquid ratio every time：The ratio of 70% ethanol of 8mL～12mL
Addition；Extracting solution decompression recycling ethanol, is concentrated into thick paste.
The preparation method of Chinese medicine external gel as above, including：
1), Acritamer 940 is scattered in a small amount of distilled water, fully swelling rear addition triethanolamine is simultaneously stirred evenly, and obtains sky
White gel；
Will be sulfur finely ground and add to stir evenly in the Blank gel and obtain the first gel mixture；
2) first gel mixture is added after, being dissolved Borneolum Syntheticum and the rheum offcinale with 70% ethanol and stir evenly
Obtain the second gel mixture；
3), PVA is added in a small amount of distilled water and heating for dissolving, by the coptis total alkaloid extract
Stir evenly in the solution that addition is obtained and obtain mixed liquor；Again the mixed liquor is added in second gel mixture and is stirred evenly
Obtain the 3rd gel mixture；
4) glycerol, Propylene Glycol, Tween-80 and ethyl hydroxybenzoate are added in the 3rd gel mixture, is stirred evenly；
Add distilled water and stir evenly and obtain final product.
Chinese medicine external gel as above can be used for treating acne, rosacea, Seborrhea and seborrheic dermatitis
Etc. disease.
Compared with prior art, beneficial effects of the present invention are：
The present invention adopts gel preparations, and each taste Chinese medicine reasonable compatibility has significantly to pathogenic bacterium such as propionibacterium acness
Inhibitory action.Chinese medicine gel not only use use than conventional dosage forms it is convenient, biocompatibility more preferably, using more comfortable,
The untoward reaction of medicine can also be mitigated, it is adaptable to wider crowd.
Component and proportioning of the present invention by optimization gel-type vehicle so that transformation of the way agent is provided with good stickiness, transdermal characteristic
And stability；Secondly, establish advanced rational extraction process, obtain to greatest extent Rhizoma Coptidis and Radix Et Rhizoma Rhei it is effective into
Point, impurity is removed, the volume and consumption of medicine is reduced, is conducive to and relevant auxiliary materials compatibility.
Specific embodiment
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the present invention.It is unreceipted concrete in embodiment
Condition person, the condition advised according to normal condition or manufacturer are carried out.Agents useful for same or the unreceipted production firm person of instrument, are
The conventional products that commercially available purchase is obtained can be passed through.
Embodiment 1
The prescription of Chinese medicine external gel that the present invention is provided is：
1), Acritamer 940 is scattered in a small amount of distilled water, fully swelling rear addition triethanolamine is simultaneously stirred evenly, and obtains sky
White gel；
Will be sulfur finely ground and add to stir evenly in the Blank gel and obtain the first gel mixture；
2), Rhizoma Coptidis decoction pieces are with after 70% ethanol immersion 50min, 70% alcohol reflux twice, first time 100min, the
Secondary 50min, the usage amount of 70% ethanol is 1g crude drugs by solid-to-liquid ratio every time：70% ethanol of 10mL；
The solution that alcohol steep is obtained is concentrated into into every milliliter of medicinal liquid comprising crude drug 0.3g, is added while hot and is accounted for medicine liquid volume
13% Sodium Chloride, is stirred to dissolve, and takes out and filters, obtain coptis total alkaloid extract after putting to room temperature cold preservation 28h.
70% ethanol of Radix Et Rhizoma Rhei decoction piece soaks 140min, 70% alcohol reflux twice, each 50min, every time 70%
The usage amount of ethanol is 1g crude drugs by solid-to-liquid ratio：70% ethanol of 8mL；Extracting solution decompression recycling ethanol, is concentrated into thick paste.
First gel mixture is added after Borneolum Syntheticum and the rheum offcinale are dissolved with 70% ethanol and is stirred evenly
To the second gel mixture；
3), PVA is added in a small amount of distilled water and heating for dissolving, by the coptis total alkaloid extract
Stir evenly in the solution that addition is obtained and obtain mixed liquor；Again the mixed liquor is added in second gel mixture and is stirred evenly
Obtain the 3rd gel mixture；
4) glycerol, Propylene Glycol, Tween-80 and ethyl hydroxybenzoate are added in the 3rd gel mixture, is stirred evenly；
Add distilled water and stir evenly and obtain final product.
Embodiment 2
The prescription of Chinese medicine external gel that the present invention is provided is：
1), Acritamer 940 is scattered in a small amount of distilled water, fully swelling rear addition triethanolamine is simultaneously stirred evenly, and obtains sky
White gel；
Will be sulfur finely ground and add to stir evenly in the Blank gel and obtain the first gel mixture；
2), Rhizoma Coptidis decoction pieces are with after 70% ethanol immersion 70min, 70% alcohol reflux twice, first time 80min, the
Secondary 70min, the usage amount of 70% ethanol is 1g crude drugs by solid-to-liquid ratio every time：70% ethanol of 14mL；
The solution that alcohol steep is obtained is concentrated into into every milliliter of medicinal liquid comprising crude drug 0.5g, is added while hot and is accounted for medicine liquid volume
17% Sodium Chloride, is stirred to dissolve, and takes out and filters, obtain Rhizoma Coptidis total alkaloidss after putting to room temperature cold preservation 20h.
70% ethanol of Radix Et Rhizoma Rhei decoction piece soaks 100min, 70% alcohol reflux twice, each 70min, every time 70%
The usage amount of ethanol is 1g crude drugs by solid-to-liquid ratio：70% ethanol of 12mL；Extracting solution decompression recycling ethanol, is concentrated into thick paste.
First gel mixture is added after Borneolum Syntheticum and the rheum offcinale are dissolved with 70% ethanol and is stirred evenly
To the second gel mixture；
3), PVA is added in a small amount of distilled water and heating for dissolving, by the coptis total alkaloid extract
Stir evenly in the solution that addition is obtained and obtain mixed liquor；Again the mixed liquor is added in second gel mixture and is stirred evenly
Obtain the 3rd gel mixture；
4) glycerol, Propylene Glycol, Tween-80 and ethyl hydroxybenzoate are added in the 3rd gel mixture, is stirred evenly；
Add distilled water and stir evenly and obtain final product.
Embodiment 3
The prescription of Chinese medicine external gel that the present invention is provided is：
1), Acritamer 940 is scattered in a small amount of distilled water, fully swelling rear addition triethanolamine is simultaneously stirred evenly, and obtains sky
White gel；
Will be sulfur finely ground and add to stir evenly in the Blank gel and obtain the first gel mixture；
2), Rhizoma Coptidis decoction pieces are with after 70% ethanol immersion 60min, 70% alcohol reflux twice, first time 90min, the
Secondary 60min, the usage amount of 70% ethanol is 1g crude drugs by solid-to-liquid ratio every time：The ratio addition of 70% ethanol of 12mL；
The solution that alcohol steep is obtained is concentrated into into every milliliter of medicinal liquid comprising crude drug 0.3g～0.5g, is added while hot and is accounted for medicinal liquid
The Sodium Chloride of volume 15%, is stirred to dissolve, and takes out and filters after putting to room temperature cold preservation 24h, obtains Rhizoma Coptidis total alkaloidss and carries
Take thing.
70% ethanol of Radix Et Rhizoma Rhei decoction piece soaks 120min, 70% alcohol reflux twice, each 60min, every time 70%
The usage amount of ethanol is 1g crude drugs by solid-to-liquid ratio：70% ethanol of 10mL；Extracting solution decompression recycling ethanol, is concentrated into thick paste.
First gel mixture is added after Borneolum Syntheticum and the rheum offcinale are dissolved with 70% ethanol and is stirred evenly
To the second gel mixture；
3), PVA is added in a small amount of distilled water and heating for dissolving, by the coptis total alkaloid extract
Stir evenly in the solution that addition is obtained and obtain mixed liquor；Again the mixed liquor is added in second gel mixture and is stirred evenly
Obtain the 3rd gel mixture；
4) glycerol, Propylene Glycol, Tween-80 and ethyl hydroxybenzoate are added in the 3rd gel mixture, is stirred evenly；
Add distilled water and stir evenly and obtain final product.
1 acne gel study of pharmacy of experimental example
1.1 extract drugs and purification
1.1.1 Rhizoma Coptidis, Radix Et Rhizoma Rhei extract solvent and select：Extracted as solvent using water and 70% ethanol respectively, obtained
Extract carries out bacteriostatic test.As a result show that rhubarb ethanol-extract and Rhizoma Coptidis alcohol extract fungistatic effect are superior to Aqueous extracts, therefore select second
Alcohol is Radix Et Rhizoma Rhei, the extraction solvent of Rhizoma Coptidis.
1.1.2 the optimization for extracting condition of Radix Et Rhizoma Rhei：Select ethanol consumption (A), extraction time and time (B), soak time
(C), two levels of four factor of concentration of alcohol (D), design L8(27) orthogonal test, evaluation index is emodin content, using HPLC
Method is determined.It is preferred that the condition for going out is A2B1C2D1, i.e., Radix Et Rhizoma Rhei decoction piece with 70% ethanol soak two hours after, reflux, extract, twice, often
Secondary 1 hour, ten times for crude drug amount of each quantity of solvent；Extracting solution decompression recycling ethanol, is concentrated into thick paste.
1.1.3 the extraction and purification of Rhizoma Coptidis：The content of berberine hydrochloride in extracting solution is determined by HPLC methods, it is determined that adopting
Rhizoma Coptidis decoction pieces are extracted after soaking one hour.Select concentration of alcohol (A), solvent load (B), three factor of extraction time and time (C)
Each three level, designs L9(34) orthogonal test, with content of berberine hydrochloride and total alkaloid content as evaluation index；It is preferred that go out
Condition is A1B3C2, i.e., after Rhizoma Coptidis decoction pieces are soaked 1 hour with 70% ethanol, reflux, extract, twice, 1.5 hours for the first time, second
1 hour, twelvefold of each quantity of solvent for crude drug amount.
The method purification Rhizoma Coptidis extract saltoutd using Sodium Chloride.Design L9(34) orthogonal test, investigating affects the master of purification
Factor liquor strength and each three levels of sodium chloride concentration are wanted, is referred to evaluate with content of berberine hydrochloride and total alkaloid content
Mark, preferably goes out purification condition and guides and support for alcohol to be concentrated into every ml medicinal liquids equivalent to crude drug 0.4g, add medicine liquid volume 15% while hot
Sodium Chloride, is stirred to dissolve, and puts to room temperature cold preservation 24 hours.Take out, filtration is precipitated thing, obtains final product.
1.2 gel forming technical studies
1.2.1 main adhesive matrix screening in gel：Six kinds of adhesive matrixes of design are respectively prepared gel, with viscosity, film forming
Performance and effective ingredient rate of release are used as performance assessment criteria.Viscosity measurement adopts dynamic viscosity method；Take sample 0.1g and be applied to health
People's inner forearm about 4cm2, observe film formation time；Using the rectilinear Franz diffusion cells method of improvement, when the same method determines different
Between put reception liquid in content of berberine hydrochloride, calculate rate of releasing drug.Integrated survey result, selectes 0.5% addition polymerization of Acritamer 940
Vinyl alcohol 05-88 5% is used as gel main matrix.
1.2.2 Percutaneous absorption enhancer screening in gel：List of references and trial test result, 7 kinds of design is containing different transdermals
The gel formula of agent, using rectilinear improved Franz diffusing cells method, is constituted diffuser casing with mouse part skin, by it is a certain amount of with
Upper 7 kinds of gels are applied to horny layer, using total alkaloid content in spectrophotometry different time points reception liquid, calculate accumulation
Transdermal amount and percutaneous rate.As a result show, Percutaneous absorption enhancer can increase the percutaneous rate of total alkaloidss in gel and accumulation
Transdermal amount, wherein the gel formula containing Propylene Glycol 10% is with there were significant differences without the gel formula of transdermal agent, therefore with 10% the third
Percutaneous absorption enhancer of the glycol as acne gel.
1.2.3 other matrix components in orthogonal experiment optimization formula：Design L9(34) orthogonal experiment, 9 kinds of gels are prepared, with
The cumulative release amount and rate of release of total alkaloidss determines pH adjusting agent triethanolamine, wetting agent in formula as performance assessment criteria
The consumption of glycerol and emulsifying agent Tween-80.According to orthogonal experiments, determine that other substrates quantities are glycerol 10%, gather
Pyrusussuriensiss ester -80 1%, triethanolamine 0.8%.
1.3 acne gel quality standards
【Character】This product is that brown color is semi-solid to yellowish brown viscous.With special odor.
【Differentiate】(1) this product 10g is taken, plus kieselguhr 10g dispersions, it is transferred in triangular flask, plus methanol 100ml supersound process
25 minutes, filtration, filtrate were evaporated, and residue adds methanol 1ml to dissolve, used as need testing solution.Rhizoma Coptidis control medicinal material 0.3g is taken separately, plus
Methanol 20ml, supersound process 20 minutes, filtration, filtrate is used as control medicinal material solution.Take palmatine hydrochloride, berberine hydrochloride, salt
Sour jateorhizine reference substance, respectively plus methanol make every 1ml containing 0.5mg solution, as reference substance solution.Try according to thin layer chromatography
Test, draw need testing solution, control medicinal material solution and each 2 μ l of reference substance solution, put on a silica gel G plate, with hexamethylene-second respectively
Acetoacetic ester-isopropanol-methanol-water-triethylamine (3：3.5：1：1.5：0.5：1) it is developing solvent, puts with strong ammonia solution presaturation 20
In the expansion cylinder of minute, launch, take out, dry, put.With comparison medicine in need testing solution chromatograph
On material, reference substance chromatograph relevant position, show identical yellow fluorescence speckle.
(2) this product 10g is taken, plus kieselguhr 10g dispersions, it is transferred in triangular flask, plus methanol 100ml, 15 points of supersound process
Clock, filtration, filtrate is evaporated, and residue adds 5ml water dissolutioies, another salt adding acid 1ml, 60 DEG C of ultrasounds 30 minutes, cools down immediately, chloroform
Shaking is extracted 2 times, 10ml/ time, is divided and is taken chloroform layer, be evaporated, and residue adds chloroform 1ml to make dissolving, molten as test sample
Liquid.Sorrel medical material 0.1g, plus methanol 20ml are taken separately, supersound process 15 minutes, remaining operation press the preparation of need testing solution
Method, obtains control medicinal material solution.Take aloe-emodin, chrysophanic acid, chrysophanol, physcione and rheum emodin reference substance, respectively plus
Methanol makes solution of every 1ml containing 1mg, used as reference substance solution.Test according to thin layer chromatography, draw need testing solution, control
Medical material solution and each 5 μ l of reference substance solution, are put on same silica gel H plate, respectively with normal hexane ethyl acetate formic acid (30：
10：0.5) it is developing solvent, launches, takes out, dry, put.With comparison medicine in need testing solution chromatograph
On material, reference substance chromatograph relevant position, show identical orange-yellow fluorescence spot, yellow sun spots；Jing after ammonia steam is smoked, speckle becomes
For redness.
(3) Borneolum Syntheticum control medicinal material 2mg is taken, plus dehydrated alcohol 1ml makes dissolving, as Borneolum Syntheticum control medicinal material solution.According to thin layer
Chromatography experiment, draws need testing solution, each 5 μ l of control medicinal material solution in above-mentioned (1), puts in same with carboxymethyl cellulose respectively
Plain sodium is on the silica gel g thin-layer plate of binding agent, with petroleum ether (30-60 DEG C)-ethyl acetate (19：2) it is developing solvent, launches, take
Go out, dry, spray with 5% vanillin-sulfuric acid solution, spot development is heated at 105 DEG C clear.In test sample chromatograph, with compare
On the corresponding position of medical material chromatograph, show same color speckle.
【Check】PH value：Acne gel 1g, plus distilled water 10ml are taken, is mixed, it is logical according to Chinese Pharmacopoeia (version four in 2015)
Then 0631pH values algoscopy test, pH value 6.0 or so.
Viscosity：Test according to the 3rd method in Chinese Pharmacopoeia (version four in 2015) 0633 viscosimetry of general rule, dynamic viscosity
For 9000Pa s or so.
【Assay】Determine according to high performance liquid chromatography (Chinese Pharmacopoeia four general rules 0512 of version in 2015).
Chromatographic condition：Chromatographic column：ZORBAX SBC18 (4.6 × 150mm, 5 μm)；Mobile phase：- 0.1% phosphoric acid water of acetonitrile
Solution (50：50) (add dodecyl sodium sulfate 0.1g per 100ml)；Flow velocity：1.0ml·min-1；Detection wavelength：265nm；Post
Temperature：Room temperature.
The preparation of reference substance solution：Take berberine hydrochloride reference substance appropriate, it is accurately weighed, plus methanol makes every 1ml and contains
The solution of 0.236mg, obtains final product.
The preparation of need testing solution：Acne gel about 1g is taken, it is accurately weighed, put in conical flask with cover, accurate addition methanol-
0.1% phosphoric acid (1:1) solution 50ml, supersound process 15 minutes, lets cool, again weighed weight, supplies the weight of less loss with methanol,
Shake up, filter, take subsequent filtrate, obtain final product.
Algoscopy：It is accurate respectively to draw 1 μ l of reference substance solution, 10 μ l of need testing solution, chromatograph of liquid is injected, is determined,
Obtain final product.
Per gram of this product must not be less than 0.25mg containing Rhizoma Coptidis in terms of berberine hydrochloride.
2 acne gel pharmacodynamic study of experimental example
2.1 aerobe bacteriostatic tests
Standard strain：Angstrom Xi Shi escherichia coli, staphylococcus aureuses and false unit cell bacillus pyocyaneus are reference culture, by
Clinical laboratory of the hospital of traditional Chinese hospital of Beijing provides.
Medicine preparation：Acne gel I, II, III, IV (content of dispersion is followed successively by 1.65%, 3.3%, 3%, 2.7%) uses physiology
Saline presses 1：2 dilution proportion gel preparations are used as stock solution.By above-mentioned stock solution autoclaving, with 2 times of doubling dilutions of aseptic culture fluid.
Operating process：With sterile working, it is applied to the bacteria suspension subregion after culture flat on blood plate respectively, 37 DEG C of incubators
Middle culture 24h, isolates single bacterium colony.Picking single bacterium colony is inoculated in 2ml sterile vegetative broth bouillons, 37 DEG C of cultures
24h.The bacteria suspension that the above-mentioned culture of a ring is taken with a fixation inoculating loop is inoculated in 2ml sterile vegetative broth bouillons again, and 37
DEG C culture 6h～8h makes fresh bacterium solution, used time dilution 10-3。
With the determination of tube method antibacterial activity in fluid medium serial dilution：Using the medicine stock solution of above-mentioned preparation as
First pipe, makees 2 times of dilutions successively with nutrient broth medium；Nutrient broth culture fluid is negative control.To in every pipe 1ml medicinal liquids
It is separately added into 10-3Fresh bacterium solution 0.1ml of dilution, cultivates 24h in 37 DEG C.In view of Chinese Medicines cannot which be muddy with perusal
Degree, so medicinal liquid bacterium solution mixed liquor is inoculated on agar culture medium, 37 DEG C of culture 24h, observation whether there is bacterial growth, with thin
The highest dilution that bacterium does not grow is minimal inhibitory concentration (Mic).
Experimental result：Acne gel is 0.168% to the Mic of golden Portugal, is 0.413% to colibacillary Mic, to green pus
The Mic of bacillus is 0.825%.
2.2 anaerobe bacteriostatic tests
Bacterial strain：Propionibacterium acness, reference culture are provided by southwestern biological industry base.
Medicine preparation：Determine that acne gel drug level is 1.4% through the preliminary screening of aerobe bacteriostatic test.Will be solidifying
Glue presses 1 with THIOGLYCOLLIC ACID salt anaerobic culture medium：2 dilution proportions, this concentration as first pipe, below by 2 times of doubling dilutions into not
Same Concentraton gradient.If the THIOGLYCOLLIC ACID salt culture fluid of drug containing is not negative control, 10U penicillins are positive control.
Operating process：With sterile working, bacterium solution is pressed into 1：10 are inoculated in thioglycollate solution medium, are placed in glove
Cultivate 2 weeks in formula anaerobic culture box.The bacteria suspension 0.1ml after culture, Anaerobic culturel are added in the medicinal liquid of every 2ml variable concentrations
1 week, in perusal culture fluid, whether there is bacteria growing, the highest dilution not grown with antibacterial is as minimal inhibitory concentration (Mic).
Experimental result：The Propiobacterium normal growth of negative control group, 10U penicillins can substantially suppress the life of anaerobe
Long, acne gel is 0.35% to the Mic of propionibacterium acness.
Finally it should be noted that：Various embodiments above only to illustrate technical scheme, rather than a limitation；To the greatest extent
Pipe has been described in detail to the present invention with reference to foregoing embodiments, but it will be understood by those within the art that：Its
Still the technical scheme described in foregoing embodiments can be modified, or to which part or all technical characteristic
Carry out equivalent；And these modifications or replacement, do not make the essence of appropriate technical solution depart from various embodiments of the present invention skill
The scope of art scheme.
Claims (10)
1. a kind of Chinese medicine external gel, it is characterised in that by weight, the Chinese medicine external gel includes following component：
Coptis total alkaloid extract, rheum offcinale, 0.2～0.8 part of sulfur, 0.2～0.8 part of Borneolum Syntheticum and aqueous gel base
800～1000 parts of matter；
In terms of the weight portion of material component, the coptis total alkaloid extract is obtained for 6～14 parts by Rhizoma Coptidis, the Radix Et Rhizoma Rhei alcohol extraction
Thing is obtained for 1～5 part by Radix Et Rhizoma Rhei.
2. Chinese medicine external gel according to claim 1, it is characterised in that by weight, the Chinese medicine external gel
Including following component：
Coptis total alkaloid extract, rheum offcinale, 0.3～0.7 part of sulfur, 0.3～0.7 part of Borneolum Syntheticum and aqueous gel base
820～990 parts of matter；
In terms of the weight portion of material component, the coptis total alkaloid extract is obtained for 8～12 parts by Rhizoma Coptidis, the Radix Et Rhizoma Rhei alcohol extraction
Thing is obtained for 2～4 parts by Radix Et Rhizoma Rhei.
3. Chinese medicine external gel according to claim 2, it is characterised in that by weight, the aqueous gel substrate
Including 40～60 parts of PVA, 4～6 parts of Acritamer 940,80～120 parts of Propylene Glycol, 80～120 parts of glycerol, three
600～660 parts of 6.4～9.6 parts of ethanolamine, 8～12 parts of Tween-80 and distilled water.
4. Chinese medicine external gel according to claim 1, it is characterised in that the Chinese medicine external gel also including 68%～
0.9～1.3 part of 72% 15～25 parts of ethanol and sterilization antiseptic.
5. Chinese medicine external gel according to claim 4, it is characterised in that the sterilization antiseptic is ethyl hydroxybenzoate.
6. the Chinese medicine external gel according to any one of Claims 1 to 5, it is characterised in that the Rhizoma Coptidis total alkaloidss are carried
It is that Rhizoma Coptidis and Radix Et Rhizoma Rhei are passed through alcohol steep, concentration, obtained after purification to take thing and rheum offcinale.
7. Chinese medicine external gel according to claim 6, it is characterised in that the extraction of the coptis total alkaloid extract
Process is specifically included：
After Rhizoma Coptidis decoction pieces are with 68%～72% ethanol immersion 50min～70min, with 68%～72% alcohol reflux two
It is secondary, first time 80min～100min, second 50min～70min, every time the usage amount of 68%～72% ethanol press solid-liquid
Than for 1g crude drugs：The ratio addition of the ethanol of 10mL～14mL 68%～72%；
The solution that alcohol steep is obtained is concentrated into into every milliliter of medicinal liquid comprising crude drug 0.3g～0.5g, Rhizoma Coptidis alcohol extract is obtained.
8. Chinese medicine external gel according to claim 7, it is characterised in that be concentrated into every milliliter of medicinal liquid in the alcohol extract
After equivalent to crude drug 0.3g～0.5g, also include：
The Sodium Chloride for accounting for medicine liquid volume 13%～17% is added while hot, is stirred to dissolve, after putting to room temperature cold preservation 20h～28h
Take out and filter, obtain coptis total alkaloid extract.
9. Chinese medicine external gel according to claim 6, it is characterised in that the extraction process of the rheum offcinale is concrete
Including：
Radix Et Rhizoma Rhei decoction piece with 68%～72% ethanol immersion 100min～140min, 70% alcohol reflux twice, every time
50min～70min, the usage amount of 70% ethanol is 1g crude drugs by solid-to-liquid ratio every time：The ratio of 70% ethanol of 8mL～12mL adds
Plus；Extracting solution decompression recycling ethanol, is concentrated into thick paste.
10. the preparation method of the Chinese medicine external gel described in any one of claim 1～9, it is characterised in that include：
1), Acritamer 940 is scattered in a small amount of distilled water, fully swelling rear addition triethanolamine is simultaneously stirred evenly, and obtains blank solidifying
Glue；
Will be sulfur finely ground and add to stir evenly in the Blank gel and obtain the first gel mixture；
2) add first gel mixture and stir evenly after, being dissolved Borneolum Syntheticum and the rheum offcinale with 70% ethanol and obtain
Second gel mixture；
3), PVA is added in a small amount of distilled water and heating for dissolving, the coptis total alkaloid extract is added
Stir evenly in the solution for obtaining and obtain mixed liquor；Again the mixed liquor is added in second gel mixture and is stirred evenly and obtained
3rd gel mixture；
4) glycerol, Propylene Glycol, Tween-80 and ethyl hydroxybenzoate are added in the 3rd gel mixture, is stirred evenly；Again plus
Enter distilled water and stir evenly to obtain final product.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107320442A (en) * | 2017-06-27 | 2017-11-07 | 广州中医药大学附属骨伤科医院 | Chinese medicine external gel and preparation method thereof |
| CN107505427A (en) * | 2017-08-22 | 2017-12-22 | 成都维恒医药科技有限公司 | A kind of thin-layered chromatography detection method of Chinese medicine sorrel |
| CN109085261A (en) * | 2018-07-24 | 2018-12-25 | 株洲千金药业股份有限公司 | A method of detection Metrogel skin permeability |
| CN110215480A (en) * | 2019-07-08 | 2019-09-10 | 嘉应学院医学院 | Four taste Asian puccoon burn gels of one kind and preparation method thereof |
| CN111110758A (en) * | 2018-10-31 | 2020-05-08 | 西南民族大学 | Ointment and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1443547A (en) * | 2002-03-07 | 2003-09-24 | 陈惠� | Ointment for curing acne and its preparation method |
| CN1879710A (en) * | 2006-05-11 | 2006-12-20 | 江苏大学 | Method for preparing rhubarb sulfur gel agent |
-
2016
- 2016-11-23 CN CN201611037248.0A patent/CN106511512A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1443547A (en) * | 2002-03-07 | 2003-09-24 | 陈惠� | Ointment for curing acne and its preparation method |
| CN1879710A (en) * | 2006-05-11 | 2006-12-20 | 江苏大学 | Method for preparing rhubarb sulfur gel agent |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107320442A (en) * | 2017-06-27 | 2017-11-07 | 广州中医药大学附属骨伤科医院 | Chinese medicine external gel and preparation method thereof |
| CN107320442B (en) * | 2017-06-27 | 2021-02-26 | 广州中医药大学附属骨伤科医院 | Traditional Chinese medicine external gel and preparation method thereof |
| CN107505427A (en) * | 2017-08-22 | 2017-12-22 | 成都维恒医药科技有限公司 | A kind of thin-layered chromatography detection method of Chinese medicine sorrel |
| CN109085261A (en) * | 2018-07-24 | 2018-12-25 | 株洲千金药业股份有限公司 | A method of detection Metrogel skin permeability |
| CN111110758A (en) * | 2018-10-31 | 2020-05-08 | 西南民族大学 | Ointment and application thereof |
| CN110215480A (en) * | 2019-07-08 | 2019-09-10 | 嘉应学院医学院 | Four taste Asian puccoon burn gels of one kind and preparation method thereof |
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Application publication date: 20170322 |