CN110279754A - A kind of Chinese medicinal granule that treating suppurative dermatosis, preparation method and applications - Google Patents

A kind of Chinese medicinal granule that treating suppurative dermatosis, preparation method and applications Download PDF

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CN110279754A
CN110279754A CN201910616615.XA CN201910616615A CN110279754A CN 110279754 A CN110279754 A CN 110279754A CN 201910616615 A CN201910616615 A CN 201910616615A CN 110279754 A CN110279754 A CN 110279754A
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chinese medicine
extract
alcohol
water
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CN110279754B (en
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陈中建
朱全刚
谢欣辛
潘会君
谢韶琼
姜文成
张红敏
连天雁
李莹
朱聪聪
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SHANGHAI DERMATOLOGY HOSPITAL
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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    • A61K2236/50—Methods involving additional extraction steps
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
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    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The present invention relates to a kind of Chinese medicine composition for treating suppurative dermatosis, the composition is made of the bulk pharmaceutical chemicals of such as the following parts by weight: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane.The preparation method of the application and the drug that the present invention also provides above-mentioned compositions in the drug of preparation treatment suppurative dermatosis.Its advantage is shown: 1, on the basis of dialectical in conjunction with the differentiation of disease, according to motherland's medicine " it is dialectical ask because; examine because opinion control " principle choose bulk pharmaceutical chemicals, it is dialectical accurate and complete, simultaneous treatment of principal and subordinate symptoms, and the effect of reuse dandelion and Fructus Forsythiae in side, play detoxification sore treatment altogether, for treating the carbuncle disease that heat toxin the is pented up person that occurs red and swollen heat pain, curative effect is excellent.2, the component of each taste Chinese medicine and its between proportion pass through experiment screening, have the advantages that significant effect.3, optimize extraction and purification process, using aqueous extraction-alcohol precipitation technology, it is big to choose technological parameters, the obtained drug extract rates such as optimum extraction temperature, solubilization dosage, heating time.

Description

A kind of Chinese medicinal granule that treating suppurative dermatosis, preparation method and applications
Technical field
The present invention relates to technical field of traditional Chinese medicines, specifically, being a kind of Chinese medicinal granule for treating suppurative dermatosis, preparation Method and its application.
Background technique
(1) social development demand
Suppurative dermatosis is common disease, and disease incidence children are higher than adult, and rural area is higher than city, accounts for about dermopathic 5%. Human body to suppurative bacterium without inborn permanent immune, therefore can repeated infection, and because being contagion, in family or child Inside garden, primary school all can mutual phase transmission, can also cause multiple complications.Environment or living condition are poor, cannot have a bath in time It changes one's clothes, easily causes a disease vulnerable to insect bites etc. are injured outside.Common disease has acne, impetigo, epifolliculitis, furuncle, carbuncle, erysipelas Deng.
Acne, Chinese medicine claim " lung-wind comedo ", " acne ", " winddorn ", " acne " etc., are more common in youth, and male is more than female, damage Evil is apt to occur in the greasiness areas such as cheek, forehead, chin portion and nose buccal groove, followed by chest, back and shoulder.From the beginning of for small papule and Running sore, if inflammation is aggravated, papular top may occur in which that the grain of rice to pea-sized pimple, leaves temporary color after ulceration or absorption Plain calm or small rut shape scar.Inflammation continues to expand and deeply, then in subcutaneously forming the light red or kermesinus knot to differ in size Section, or slightly higher than surface.Such damage can longer-term exist, be gradually absorbed or suppuration ulceration after form scar.Modern times doctor Think that acne is to invade the chronic inflammation skin disease of hair follicle, pilo-sebaceous unit, and pathogenesis does not illustrate completely yet.Heredity, Androgen induction sebum largely secrete, pilosebaceous duct angling, propionibacterium acnes and aerobic staphylococcus etc. are numerous Grow, the factors such as inflammation and immune response be likely to it is associated.As people's rhythm of life is accelerated, life stress increases, ring Border pollution aggravation etc., the morbidity of this disease is in rising trend.
Impetigo is commonly called as " impetigo ", is a kind of bacterium infection dermatoses for being apt to occur in children, and patient is easy to pass through Scratching infection site and infection is disseminated to itself or other people, clinically have big kitchen property impetigo, non-big kitchen property impetigo and Portugal The coccus scald sample skin syndrome of grape.Its main pathogenic fungi is staphylococcus aureus, is secondly A group hemolytic chain The mixed infection of coccus and the two.Treatment impetigo mainly includes that local topical antibiotic and oral antibiotic and system are used Medicine.
Epifolliculitis is purulent inflammation caused by bacterium infection hair follicle, mainly caused by the S. aureus L-forms of coagulase positive, Secondary is staphylococcus albus.It is mainly in head, four limbs, perineum etc..From the beginning of for the big pityriasis rubra papule of grain grain, gradually form Warts occurs in batches, does not merge mutually.A small amount of purulence blood, no purulent core can be discharged after warts is broken.Warts 4-5 days absorbable, generally not Scar is stayed, but easy to recur, can delayed the several months long.It is apt to occur in the young and the middle aged, domestic common with male, men and women's ratio is 2.2: 1, average Age is about thirty years old.May be vigorous with young people's metabolism, it moves more and causes to perspire more related；In addition, summer disease incidence compared with Height, prompting high temperature, perspiration and humidity etc. is an important factor for inducing or aggravate epifolliculitis.
(2) status both at home and abroad, level and development trend
1, the western medical treatment of suppurative dermatosis:
Modern medicine thinks its morbidity and endocrine, pilosebaceous duct dyskeratosis, microorganism infection, immune, something lost It is related the factors such as to pass, in addition cosmetics improper use, stress excessively, tobacco and wine and pungent sweet food etc. can become plus Weight and/or precipitating factor.
(1) local treatment: principle is cleaning, anti-inflammatory, drying, restrains, prevents from spreading.
1. can externally used antimicrobial drug such as 1% lincomycin gel, 10% sulfanilamide (SN) to the erythema, papule, pimple of non-ulceration Vinegar acyl sodium solution, 0.5% neomycin ointment or 2% mupirocin ointment, 0.5% erythromycin ointment, 3% Ciprofloxacin ointment, 1% povidone ointment etc.；
2. biggish warts can be punctured with sterile needle, fester is exhausted to prevent spilling over normal skin with sterile dry cotton ball, then use Above-mentioned external preparation；
3. preferred Wet-dressing agent soak, the extensive person of area answers gradation soak to exudation, erosion, incrusted skin lesion, drug is prevented Absorb poisoning.
(2) systematic treating: acne often uses Doxycycline and minocycline etc. oral.Impetigo often uses the wide of penicillin resistant enzyme Oral semi-synthetic penicillins, intramuscular injection or intravenous drip are composed, such as Amoxicillin, methicillinum；Person allergic to penicillin can Select quinolones (children are used with caution), macrolides such as erythromycin, azithromycin or cephalosporin analog antibiotic.Epifolliculitis should be selected With appropriate antibiotic, such as sulfamido, penicillin, cephaloridnum or gentamicin；Hormone such as Itraconazole, ketoconazole etc..
(3) physiotherapy: ultraviolet light, ultrashort wave irradiation.
Although doctor trained in Western medicine takes multiple therapy methods for suppurative dermatosis, very big effect is achieved, such as in acne Promote the normal angling of follicular epithelium, antibiotic and hormone medicine killing intrafollicular frequently with anti-angling medicine in conventional therapy Bacterium reduces free fatty acid amount, mitigates inflammatory reaction, but western medicine also faces some problems, as that there are bacteriums is resistance to for medication Pharmacological property, the problems such as easy to recur, the course for the treatment of is longer, costly.Past, Propiobacterium had the drug resistance of antibiotic aobvious over 25 years The rising of work reaches 62% in Britain, now has become international problem.
2, the Chinese traditional treatment of suppurative dermatosis:
(1) theory of traditional Chinese medical science: Chinese medicine thinks that suppurative dermatosis is mostly to experience summer-heat and damp heat toxin so that functional activity of QI being not smooth, catharsis are lost Often, it fumigates skin and causes.Summer-heat being a kind of YANG pathogen, property are hot, have a slight heat bringing about itching, overabundace of heat bringing about pain, excess heat then features such as meat corruption, table It is now that affected part abscess is scorching hot, the stream that rots is grown.Burning hot heresy easy entry blood system gathers in part, and corroding flesh and blood hair is carbuncle swells sore.Heat The heresy of heat is contained partially, can cause fever, thirsty, just dry symptoms such as red of urinating；Summer-heat often mixed with damp, dampness being heavy and turbid stick greasy, easily cause blister gruel Rotten, contamination four is altered, exudation.Therefore, the interpretation of the cause, onset and process of an illness should be held by treating such disease, according to state of an illness weight and skin lesion development characteristic, Diagnosis and treatment based on an overall analysis of the illness and the patient's condition, clearing heat-fire removing toxic substances, eliminating dampness and heat.Its so-called " poison " connotation of Chinese medicine is very wide, in addition to including intimately stopping up caused by containing Except heat toxin, fire toxin, poison is also referred to as to infection such as extraneous some pathogenic factors such as bacterium, virus, helminth.Traditional Chinese medicine As the distinctive treatment means in China, experience abundant is had accumulated during long-term clinical practice, shows uniqueness Advantage.In the case where antibiotics resistance is on the rise, pay attention to traditional Chinese medicine in treatment infective factors using very It is necessary.It is heat toxin syndrome that clinically the suppurative dermatosis such as many infective factors such as acne, epifolliculitis, impetigo are often dialectical. Method of dissipating heat and detoxifying is the method for common treatment heat toxin disease, cooperates other therapies treatment furuncle ulcerative carbuncle pyogenic infections etc. with method of dissipating heat and detoxifying Infectious diseases is with a long history, experienced, significant in efficacy.The thus drug of clearing heat and detoxicating righting, such as honeysuckle, Fructus Forsythiae, Pu Public English, wild chrysanthemum, the coptis, radix scutellariae, Cortex Phellodendri, cape jasmine, Chinese violet etc. are subject to dialectical, can be used for treating acne, epifolliculitis, suppuration Bacterial dermatosis and its relevant skin disease.
(2) Chinese medicine mechanism of action: in recent years, with the development that herbal pharmacology is studied, traditional Chinese medicine is to acne, epifolliculitis, purulence The research of the suppurative dermatosis such as blister sore effect has made great progress, and the pharmacological mechanism of antipyretic and antidotal type Chinese medicine is by gradually Disclose, on the basis for the treatment of tradition burning hot disease its goal in research from past single improvement clinical symptoms to focus in recent years with Doctor trained in Western medicine pathogenesis combines, with anti-pilosebaceous duct angling, antibacterial, it is anti-inflammatory, adjust immune and sex hormone activity etc. and make With for evaluation index, the validity of traditional Chinese medicine treatment suppurative dermatosis is objectively confirmed.If single medicinal material extract is for anti- Bacterium is anti-inflammatory and promotes the existing many reports of immune etc. Mechanism Study.Radix Isatidis infusion is double to staphylococcus aureus, pneumonia 10 kinds of bacteriums such as coccus, Bacillus influenzae, diplococcus meningitidis have inhibiting effect；Its difference extraction position can inhibit dimethylbenzene Caused acute inflammatory reaction.Andrographis Paniculata has stronger antibacterial power to coagulase-negative staphylococci.Herba Andrographitis Main active andrographolide has bacillus subtilis, Escherichia coli, staphylococcus aureus etc. stronger antibacterial Activity also has and promotes immunocompetent cell proliferation, increases the phagocytosis and wandering index of macrophage, improve CD3, The ratio of CD4.CD8 cell increases immune function.Fructus Forsythiae macroreticular resin extract part paraxylene or croton oil induced mice Ear swelling, fever in rabbits caused by endotoxin have certain antagonism；Volatile oil, chromatography volatile oil and nopinene exist in Fructus Forsythiae There is inhibiting effect to 10 kinds of bacterial strains such as Escherichia coli, staphylococcus aureus, pneumococcus, haemophilus influenzae in vitro.Horse Bitterroot to various conventional food contaminated bacterias such as Escherichia coli, salmonella, Shigella, staphylococcus aureus etc. have compared with Strong inhibiting effect, wherein Flavonoid substances may be most important antipathogenic composition in purslane；Purslane alcohol extract is to diformazan Mice auricle swelling caused by benzene or croton oil has antagonism, and can be substantially reduced acute eczema rat skin tissue T NF- α, IL-4 content are substantially reduced (p < 0.05), have obvious curative effects to eczema skin.Dandelion ethanol extract can partially inhibit angle Rat caused by fork dish glue is wasted time swelling enough, and the swelling of paraxylene induced mice ear has certain inhibiting effect；Dandelion has wide Bacteriostasis is composed, different parts extract has not gram-positive bacteria, Gram-negative bacteria, fungi, conveyor screw and virus With the inhibiting effect of degree.Its inhibit staphylococcus aureus mechanism may with influence staphylococcic biomembrane and EDNA burst size is related.Flos Chrysanthemi Indici extract stoste has certain inhibiting effect to staphylococcus aureus, Escherichia coli etc., and Mechanism of action is different with medecamycin；It is swollen that wild chrysanthemum water decoction and composition and effectiveness can inhibit Mice Auricle caused by dimethylbenzene Mouse peritoneal capillary permeability caused by swollen and acetic acid increases.Certain Chinese prescriptions and Chinese patent drug etc. can significantly reduce hair The permeability of thin blood vessel, common pathogen and staphylococcus aureus, staphylococcus epidermis and acne propionic acid to acne vulgaris Bacillus is inhibited, and as observed after Chinese medicinal formulae treatment, the follicular orifice angling of patient mitigates.In addition, some Chinese medicines and Prescription also has certain effect to immunological regulation, and Wu little Hong etc. has found Acne Vulgaris, and (oldenlandia diffusa, Radix Salviae Miltiorrhizae, radix scutellariae, summer are withered Grass etc.) it lg-G and IL-2 can be significantly changed in patients with acne peripheral blood puts down (P < 0.01 and P < 0.05), thus it is speculated that the mixture is to thin The adjustment effect of born of the same parents and humoral immunity is one of mechanism of its clinical treatment.The researchs such as Kou Xiao find heat-clearing acne soup (mother chrysanthemum Flower, dandelion, viola mandshurica, honeysuckle, polygonum cuspidate etc.) it can obviously inhibit delayed allergy and inflammatory reaction, it can obviously drop Low periphery splenic T-lymphocyte subsets and immune organ organ index have exact anti-inflammatory effect.In addition studies have found that Chinese Herbal Active Ingredients ingredient is shown with antibacterial and anti-inflammation functions, for example has preferable In Vitro Bacteriostasis to propionibacterium acnes, Tanshinone can reduce the sebum secretion of patients with acne, have definite curative effect to delayed female.The dissociated anthraquinone of rheum officinale is to Cuo Sore main pathogenic bacteria has stronger In-vitro Inhibitory Effect.
(3) clinical application
For thousands of years, the Chinese nation is able to prosperity by the special advantage of traditional Chinese medicine " simplicity is tested honest and clean ".Traditional Chinese medicine is ground Preparation is always the emphasis of country's investment due to being clinically widely used in hair process intermediate court.But specifically in clinical application On, the clinical research of single medicinal material is few, and tcm clinical practice is mostly used compound, also more meets theory of traditional Chinese medical science, but the stronger side of feasibility Case is few, and majority rests on animal experiment stage.Though part research has carried out clinical test, mostly based on decoction, for a long time Inconvenience is taken, therefore affects its popularization.It is more that costly medicine is formed by part prescription again, it is very big to take financial burden for a long time.
In addition, in the prior art the formulation method of drug have the defects that it is certain: medicinal extract rate is high, drug is uneven, easily Agglomeration, manufacturing cost height, preparation method complexity etc..
Inventor in view of the drawbacks of the prior art, has studied a kind of Chinese medicinal granule for treating suppurative dermatosis of the present invention, And optimize preparation method, and experiments have shown that: the drug extract rate that preparation method of the invention obtains is high, and curative effect is good；The present invention chooses Chinese medicine composition and its between proportion be optimal selection, therapeutic efficiency is high.
Summary of the invention
The first purpose of this invention is in view of the deficiencies of the prior art, to provide a kind of Chinese medicine for treating suppurative dermatosis Composition.
Second object of the present invention is in view of the deficiencies of the prior art, to provide the purposes of above-mentioned Chinese medicine composition.
Third object of the present invention is in view of the deficiencies of the prior art, to provide a kind of Chinese medicine for treating suppurative dermatosis Particle.
Fourth object of the present invention is in view of the deficiencies of the prior art, to provide the Chinese medicine of above-mentioned treatment suppurative dermatosis The preparation method of particle.
To realize above-mentioned first purpose, the technical solution adopted by the present invention is that:
A kind of Chinese medicine composition for treating suppurative dermatosis, the composition by such as the following parts by weight bulk pharmaceutical chemicals system At: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane.
As a preferred embodiment of the invention, clinically acceptable medicine is made according to Chinese medicine customary preparation methods Object preparation.
To realize above-mentioned second purpose, the technical solution adopted by the present invention is that:
Application of the Chinese medicine composition as described above in the drug of preparation treatment suppurative dermatosis.
As a preferred embodiment of the invention, the suppurative dermatosis be acne, impetigo, epifolliculitis, furuncle, Carbuncle, erysipelas.
To realize above-mentioned third purpose, the technical solution adopted by the present invention is that:
A kind of Chinese medicinal granule for treating suppurative dermatosis, the particle are made of above-mentioned Chinese medicine composition, the particle Preparation method include the following steps:
(1) water mentions twice: the bulk pharmaceutical chemicals of parts by weight: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane such as weighing, often Secondary amount of water is 8 times of bulk pharmaceutical chemicals total weight, is decocted 2 times, 2 hours every time, collecting decoction, filtration obtained filtrate；
(2) alcohol precipitation: it is 1.2 that the filtrate decompression that step (1) obtains, which is concentrated into medicinal extract density, is slowly added to 95% ethyl alcohol extremely Determining alcohol is 70%, is stood overnight, filtrate decompression concentration and recovery to no alcohol taste, continue to be concentrated into relative density be 1.10 it is clear Cream；
(3) in the medicinal extract for obtaining auxiliary material addition step (2), it is dextrin that the auxiliary material, which is weight proportion: lactose=3:2, Mix, be added 10% vinylpyrrolidone K30-95% ethanol solution, granulation, vacuum drying to get.
As a preferred embodiment of the invention, the suppurative dermatosis be acne, impetigo, epifolliculitis, furuncle, Carbuncle, erysipelas.
To realize above-mentioned 4th purpose, the technical solution adopted by the present invention is that:
A kind of preparation method of Chinese medicinal granule that treating suppurative dermatosis, the method is water extraction and alcohol precipitation method；The side Method includes the following steps:
(1) water mentions twice: the bulk pharmaceutical chemicals of parts by weight: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane such as weighing, often Secondary amount of water is 8 times of bulk pharmaceutical chemicals total weight, is decocted 2 times, 2 hours every time, collecting decoction, filtration obtained filtrate；
(2) alcohol precipitation: it is 1.2 that the filtrate decompression that step (1) obtains, which is concentrated into medicinal extract density, is slowly added to 95% ethyl alcohol extremely Determining alcohol is 70%, is stood overnight, filtrate decompression concentration and recovery to no alcohol taste, continue to be concentrated into relative density be 1.10 it is clear Cream；
(3) in the medicinal extract for obtaining auxiliary material addition step (2), it is dextrin that the auxiliary material, which is weight proportion: lactose=3:2, Mix, be added 10% vinylpyrrolidone K30-95% ethanol solution, granulation, vacuum drying to get.
As a preferred embodiment of the invention, step (3) method includes:
A: in the medicinal extract merging granulation pot that step (2) is obtained, dextrin is added, with main stirring 300rpm and cutter It is mixed under 500rpm speed and stops stirring to get the first semi-finished product after ten minutes；
B: being added lactose into the first semi-finished product that step a is obtained, with main stirring 300rpm and cutter 500rpm speed Lower mixing stops stirring to get the second semi-finished product after ten minutes；
C: the second semi-finished product that step b is obtained are added at main stirring 300rpm and cutter 1500rpm velocity conditions PVPK30-95% alcohol slurry, cross the wet whole grain of 14 meshes, through 60 DEG C vacuum drying to get.
As a preferred embodiment of the invention, the method also includes tlc identification methods.
Fang Xie:
Dandelion, Fructus Forsythiae in side: " its property is refrigerant, controls all furunculosis, large carbuncle, all cards of red and swollen heat toxin, can take can for dandelion It applies, quite has confirmed, and control the acute mastitis furuncle of the breast, red and swollen heavily fortified point block, especially prompt effect.Fresh person smashes juice and warmly takes, and does person's decoction, can also control simply It, and in the side of boiling medicine must it is indispensable this." " tool rises the power of floating surname dissipate to Fructus Forsythiae, and circulate qi and blood, controls 12 and gathers through blood clotting gas, is sore Family's key medicine.Energy flesh inducing diaphoresis thoroughly, heat-clearing are to control wind-heat key medicine by wind.And performance eliminating toxic is outgoing, and to deliver rash addiction key medicine." The shared dandelion of we and Fructus Forsythiae, Fructus Forsythiae detoxicating and resolving a mass disappear carbuncle；The removing toxic substances of dandelion bitter-cold herbs expelling heat.Two medicines 5 are used, and have detoxification sore treatment The effect of, it is the monarch drug in a prescription of we for treating the acute mastitis that heat toxin the is pented up person that occurs red and swollen heat pain.Wild chrysanthemum: it is clearing heat and detoxicating, it rushes down Fiery calming the liver is used for carbuncle swells sore, red eye, swell pain, headache and dizziness.Dandelion compatibility chrysanthemum dandelion is clearing heat and detoxicating；Chrysanthemum calming the liver Improving eyesight.The two 5 is used, and has the effect of removing toxic substances improving eyesight, for treating the red eye, swell pain attacked in wind-heat.It therefore is the auxiliary part of our minister. Herba Andrographitis, purslane: Herba Andrographitis " clearing heat and detoxicating, anti-inflammatory detumescence.Control laryngopharyngitis, dysentery, high fever." purslane it is pungent it is cold can be cool Blood heat dissipation, therefore primary symptom knot, ulcerative carbuncle malignant boil is swollen, and white bald and 36 kinds of wind knot sores apply, and swollen scattered malignant boil is eradicated, and twists juice clothes and then dislikes object Instantly, it is inside and outside apply all.Pungent cold tonneau, therefore fever and chills are gone, size is convenient.It is for our adjutant.In conclusion our Clearing heat and detoxicating, clear carbuncle dissipating bind function can be used for treating suppurative dermatosis such as impetigo, epifolliculitis etc..Each medicine primary and secondary used has Sequence, it is well arranged, meet the principles of formulating prescriptions of science of TCM formulas.
The effect of reusing dandelion and Fructus Forsythiae in side, playing detoxification sore treatment altogether, it is red for treating the carbuncle disease appearance that heat toxin is pented up Swell hot pain person, and curative effect is more comprehensively.
The invention has the advantages that:
1, prescription is rigorous, examines because opinion is controlled
Differential diagnosis in tcm thinks suppurative dermatosis, belongs to " heat toxin disease " scope, and clinical syndrome differentiation is attributed to retention of damp-heat in the interior more, pents up flesh Skin, strongly fragrant longization heat, for the corruption of excess heat meat at purulence, when treatment, mostly uses greatly clearing heat and detoxicating, dispelling wind and eliminating dampness medicine.We are above-mentioned dialectical On the basis of in conjunction with the differentiation of disease, formed according to the principle prescription of motherland's medicine " dialectical to ask because examining because opinion is controlled ", full side is total to the five tastes Chinese medicine meets " monarch " combination principle, can obviously significantly improve many symptoms such as red, swollen, pain, heat, dysfunction, After rotten rotten sore face warts is formed a scab, and scab falls off, new skin lesion is not had and is gone out, have certain antibacterial, anti-inflammatory, raising immunity etc. to make With, it is curative for effect, it also has no adverse reaction during clinical use, there is good exploitation basis.
2, by pharmacodynamic test, optimization is extracted and purifying process, including improves the works such as extraction, concentration, drying, preparations shaping Skill process key parameter, carrys out effective component extracting to greatest extent.
3, the component of each taste Chinese medicine of the present invention and its between proportion pass through experiment screening, have the advantages that significant effect, The pain for alleviating patient improves the quality of life of patient；In addition, optimization preparation method and each technological parameter, to greatest extent Ground extracts effective component；Furthermore the present invention mainly selects water and medicinal alcohol during the preparation process, and wherein alcohol can return Receive recycle, waste water through sewage disposal system handle it is up to standard after discharge, will not have any impact to environment, preparation method Can industrialization, can mass production, have very strong practicability, can well be applied to clinically.
Detailed description of the invention
Attached drawing 1 is the thin layer identification result figure of Herba Andrographitis in we, wherein (1) negative controls；(2) test sample；(3) Standard items；(4) control medicinal material.
Attached drawing 2 is the thin layer identification result figure of dandelion in we, wherein (1) negative controls；(2) control medicinal material；(3) Test sample 1；(4) test sample 2.
Attached drawing 3 is the thin layer identification result figure of Fructus Forsythiae in prescription, wherein (1) standard items；(2) control medicinal material；(3) for examination Product；(4) negative controls.
Attached drawing 4 is chromatographic results figure, wherein A. forsythin reference substance solution B. test solution C. negative controls are molten Liquid.
Attached drawing 5 is linear standard curve (AS-Vol).
Attached drawing 6 is blank control group lump dermal pathology form HE colored graph, HE, X20.
Attached drawing 7 is blank control group lump dermal pathology form HE colored graph, HE, X100.
Attached drawing 8 is model group lump dermal pathology form HE colored graph, HE, X20.
Attached drawing 9 is model group lump dermal pathology form HE colored graph, HE, X100.
Attached drawing 10 be western husband acid group lump dermal pathology form HE colored graph, HE, X20.
Attached drawing 11 be western husband acid group lump dermal pathology form HE colored graph, HE, X100.
Attached drawing 12 is Chinese medicine composition extract low dose group lump dermal pathology form HE colored graph, HE, X20.
Attached drawing 13 is Chinese medicine composition extract low dose group lump dermal pathology form HE colored graph, HE, X100.
Attached drawing 14 is Chinese medicine composition extract middle dose group lump dermal pathology form HE colored graph, HE, X20.
Attached drawing 15 is Chinese medicine composition extract middle dose group lump dermal pathology form HE colored graph, HE, X100.
Attached drawing 16 is Chinese medicine composition extract high dose group lump dermal pathology form HE colored graph, HE, X20.
Attached drawing 17 is Chinese medicine composition extract high dose group lump dermal pathology form HE colored graph, HE, X100.
Specific embodiment
The invention will be further elucidated with reference to specific embodiments.It should be understood that these embodiments are merely to illustrate this hair It is bright rather than limit the scope of the invention.In addition, it should also be understood that, after having read the content of the invention recorded, this field skill Art personnel can make various changes or modifications the present invention, and such equivalent forms equally fall within the application the appended claims Limited range.
A kind of Chinese medicine composition (one) for treating suppurative dermatosis of embodiment 1
The parts by weight such as take to take bulk pharmaceutical chemicals: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane.
A kind of Chinese medicine composition (two) for treating suppurative dermatosis of embodiment 2
Bulk pharmaceutical chemicals are taken according to following parts by weight: 1 part of dandelion, 2 parts of Herba Andrographitis, 3 parts of wild chrysanthemum, 4 parts of Fructus Forsythiae, purslane 5 Part.
A kind of Chinese medicine composition (three) for treating suppurative dermatosis of embodiment 3
Bulk pharmaceutical chemicals are taken according to following parts by weight: 0.5 part of dandelion, 1 part of Herba Andrographitis, 1.5 parts of wild chrysanthemum, 2 parts of Fructus Forsythiae, horse 2.5 parts of bitterroot.
A kind of Chinese medicine composition (four) for treating suppurative dermatosis of embodiment 4
Bulk pharmaceutical chemicals are taken according to following parts by weight: 1 part of dandelion, 2 parts of Herba Andrographitis, 1.5 parts of wild chrysanthemum, 2.5 parts of Fructus Forsythiae, horse 2 parts of bitterroot.
A kind of Chinese medicinal granule (one) for treating suppurative dermatosis of embodiment 5
The preparation method is as follows:
(1) water mentions twice: weighing bulk pharmaceutical chemicals: 5 parts of dandelion, 5 parts of Herba Andrographitis, 5 parts of wild chrysanthemum, 5 parts of Fructus Forsythiae, purslane 5 Part, each amount of water is 8 times of bulk pharmaceutical chemicals total weight, is decocted 2 times, 2 hours every time, collecting decoction, filtration obtained filtrate；
(2) alcohol precipitation: it is 1.2 that the filtrate decompression that step (1) obtains, which is concentrated into medicinal extract density, is slowly added to 95% ethyl alcohol extremely Determining alcohol is 70%, is stood overnight, filtrate decompression concentration and recovery to no alcohol taste, continue to be concentrated into relative density be 1.10 it is clear Cream；
(3) in the medicinal extract merging granulation pot obtained step (2), 3 parts of dextrin are added, with main stirring 300rpm and cutting It is mixed under knife 500rpm speed and stops stirring to get the first semi-finished product after ten minutes；
2 parts of lactose are added, into the first semi-finished product to mix 10 points under main stirring 300rpm and cutter 500rpm speed Stop stirring to get the second semi-finished product after clock；
By the second semi-finished product at main stirring 300rpm and cutter 1500rpm velocity conditions, PVPK30-95% second is added Alcohol slurry, cross the wet whole grain of 14 meshes, through 60 DEG C vacuum drying to get.
A kind of Chinese medicinal granule (two) for treating suppurative dermatosis of embodiment 6
The preparation method is as follows:
(1) water mentions twice: weighing bulk pharmaceutical chemicals: 5 parts of dandelion, 5 parts of Herba Andrographitis, 5 parts of wild chrysanthemum, 5 parts of Fructus Forsythiae, purslane 5 Part, each amount of water is 10 times of bulk pharmaceutical chemicals total weight, is decocted 1 time, and decocting time is 1 hour, and collecting decoction, filtration obtains Filtrate；
(2) alcohol precipitation: it is 1.8 that the filtrate decompression that step (1) obtains, which is concentrated into medicinal extract density, is slowly added to 85% ethyl alcohol extremely Determining alcohol is 80%, is stood overnight, filtrate decompression concentration and recovery to no alcohol taste, continue to be concentrated into relative density be 1.50 it is clear Cream；
(3) in the medicinal extract merging granulation pot obtained step (2), 3 parts of dextrin are added, with main stirring 500rpm and cutting Stop stirring to get the first semi-finished product after mixing 8 minutes under knife 800rpm speed；
2 parts of lactose are added, into the first semi-finished product to mix 8 minutes under main stirring 500rpm and cutter 800rpm speed Stop stirring to get the second semi-finished product afterwards；
By the second semi-finished product at main stirring 500rpm and cutter 2000rpm velocity conditions, PVPK30-85% second is added Alcohol slurry, cross the wet whole grain of 14 meshes, through 60 DEG C vacuum drying to get.
A kind of Chinese medicinal granule (three) for treating suppurative dermatosis of embodiment 7
The preparation method is as follows:
(1) water mentions twice: weighing bulk pharmaceutical chemicals: 5 parts of dandelion, 10 parts of Herba Andrographitis, 15 parts of wild chrysanthemum, 12.5 parts of Fructus Forsythiae, horse 25 parts of bitterroot, each amount of water is 10 times of bulk pharmaceutical chemicals total weight, is decocted 1 time, and decocting time is 1 hour, collecting decoction, filter It crosses to obtain filtrate；
(2) alcohol precipitation: it is 1.8 that the filtrate decompression that step (1) obtains, which is concentrated into medicinal extract density, is slowly added to 85% ethyl alcohol extremely Determining alcohol is 80%, is stood overnight, filtrate decompression concentration and recovery to no alcohol taste, continue to be concentrated into relative density be 1.50 it is clear Cream；
(3) in the medicinal extract merging granulation pot obtained step (2), 3 parts of dextrin are added, with main stirring 500rpm and cutting Stop stirring to get the first semi-finished product after mixing 8 minutes under knife 800rpm speed；
3 parts of lactose are added, into the first semi-finished product to mix 15 points under main stirring 300rpm and cutter 500rpm speed Stop stirring to get the second semi-finished product after clock；
By the second semi-finished product at main stirring 500rpm and cutter 2000rpm velocity conditions, PVPK30-80% second is added Alcohol slurry, cross the wet whole grain of 14 meshes, through 60 DEG C vacuum drying to get.
A kind of decoction for preparing treatment suppurative dermatosis of embodiment 8
The preparation method is as follows:
The bulk pharmaceutical chemicals of parts by weight: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane such as take, amount of water is that bulk pharmaceutical chemicals are total 8 times of weight decoct 2 times, and each decocting time is 2 hours, and filtering merges decoction liquor twice.
A kind of capsule/the capsule for preparing treatment suppurative dermatosis of embodiment 9
The preparation method is as follows:
The bulk pharmaceutical chemicals of parts by weight such as take: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane add 8 times of amount water, big to burn It opens, small fire decocts 2 hours；Filtration, filtrate concentration, is cooled to room temperature；Supernatant is taken, thick medicinal extract is concentrated into；It is auxiliary that pharmacy is added Material, vacuum drying crush granulation, and tabletted or filling is encapsulated.Whole preparation process is only decocted primary.
The screening of 10 preparation process of embodiment
1 dosage form selection
In order to further explore optimum extraction process, this research is quasi- by pharmacodynamic test, to extraction solvent and technique Carry out preliminary screening.And system optimization is carried out to the extracting method of screening, so that it is played more outstanding curative effect.
2 experimental materials and instrument
1 experimental material of table
2 laboratory apparatus of table
3 Study on extraction
The selection of 3.1 extracting methods
Since the medicine is by the compound preparation of 5 taste Chinese medicinal compositions, ingredient is complex.Prescription Chinese medicinal materials are only in chrysanthemum containing waving Hair property ingredient it is more, most medicinal materials contain the ingredients such as flavones, terpene, organic acid, therefore, for extract to greatest extent effectively at Point, different Extraction solvents is selected, gained medicinal extract selects suitable extracting method through medicine efficacy screening, according to pharmacodynamic results.Method It is as follows:
(1) 80% ethyl alcohol extracts: it takes medicinal material to amount to 100g, 80% ethyl alcohol is added and extracts 1L, is heated to reflux 2 hours, filters, 80% ethyl alcohol 800mL is added in filter residue, is heated to reflux 2 hours, filters, and merging filtrate is recovered under reduced pressure ethyl alcohol, is evaporated to obtain medicinal extract, batch Numbers 20170521.
(2) 30% ethyl alcohol extract: it takes medicinal material to amount to 100g, 30% ethyl alcohol is added and extracts 1L, is heated to reflux 2 hours, filters, 30% ethyl alcohol 800mL is added in filter residue, is heated to reflux 2 hours, filters, and merging filtrate is recovered under reduced pressure ethyl alcohol, is evaporated to obtain medicinal extract, batch Numbers 20170522.
(3) water extracts: taking medicinal material to amount to 1000g, adds water 1L, decoct 2 hours, filtering, filter residue adds water 800mL, decocts 2 Hour, filtering, merging filtrate, being concentrated under reduced pressure into medicinal extract density is 1.2, is evaporated to obtain medicinal extract, lot number 20170523.
(4) water extract-alcohol precipitation: taking medicinal material to amount to 100g, adds water 1L, decocts 2 hours, and filtering, filter residue adds water 800mL, decocts 2 Hour, filtering, merging filtrate, being concentrated under reduced pressure into medicinal extract density is 1.2, and being slowly added to 95% ethyl alcohol to determining alcohol is 70%, is put It sets overnight, filtrate decompression concentration and recovery is evaporated to obtain medicinal extract, lot number 20170524.
Above-mentioned 4 kinds of extracting method results see the table below 3.1.
3.1 4 kinds of Different Extraction Method results of table
Medicine efficacy screening is carried out to above-mentioned 4 samples respectively, low dose group presses 1g/g, and high dose group is administered by 5g/g, observation The antibacterial effect of each sample.
The antibacterial action result a of 3.2 4 sample various doses of table
A inhibition zone size (mm)
Table 3.2 the results show that the sample that extracts of four kinds of methods to Escherichia coli, pseudomonas aeruginosa, Candida albicans Bacterium all has biocidal property without apparent bacteriostasis, to staphylococcus aureus, wherein dry extract made from aqueous extraction-alcohol precipitation technology Best to staphylococcus aureus biocidal property, drug effect is best, therefore extraction process will use water extraction and alcohol precipitation method.
To select optimum extraction process, orthogonal test is carried out to the technique.Due to aqueous extraction-alcohol precipitation technology in two stages into Row, and the influence factor in the two stages is different, so being mentioned to water and two steps of alcohol precipitation carry out orthogonal test respectively.
3.2 extraction process by water orthogonal tests
This 3 factors being affected to the water extracted immersing paste yield of selection and withdrawal number, extraction time and amount of water are as just It hands over the investigation factor of experiment to carry out Orthogonal Experiment and Design, is shown in Table shown in 3.3.
3.3 extraction process by water orthogonal optimization test factor level table of table
Use L9(33) the optimization experiment of orthogonal trial extraction process by water, specific experiment arrangement such as table 3.4.
3.4 water of table proposes orthogonal design table
The range analysis of 3.5 extraction process by water orthogonal experiment of table
Horizontal quadrature test is carried out according to table 3.5, respectively with the comprehensive of the sum of yield of extract scoring and Determination of forsythin scoring Closing scoring is that inspection target carries out range analysis to orthogonal test, and data are shown in Table 3.5.As can be known from the above table, it is carried out in same factor Compare, it is known that optimal level experimental group is A2B2C1；By very poor R value size it is found that influencing the factor primary and secondary sequence of comprehensive score Are as follows: B (extraction time) > A (extraction time) > C (amount of water).Therefore A is chosen2B2C1The extraction that is solved as the party of factor level Technique determines that water mentions optimum process are as follows: extract 2 times, every time 2 hours, 8 times of amount of water.
3.3 water propose the verifying of experiment optimal conditions
Three parts of five kinds of total 100g of prescription medicine are weighed, are tested by optimum extraction process, verification result is shown in Table 3.6.
3.6 extraction process by water confirmatory experiment result of table
Three times in experiment in medicinal extract forsythin average content relative standard deviation RSD=1.19% < 3%, what is required In range, show that the optimum extraction process is stable, reliable, determines that the technique most preferably mentions for what Chinese medicinal granule water of the invention mentioned Taking technique.
3.4 alcohol precipitation process orthogonal tests
After determining extraction process by water, orthogonal test is carried out to alcohol precipitation process, selects best alcohol precipitation process.Choose concentration of alcohol (V/V), this 3 factor conducts being affected to Determination of forsythin of the relative density of time of repose and concentrated extract when alcohol precipitation The investigation factor of orthogonal experiment carries out Orthogonal Experiment and Design, is shown in Table shown in 3.7.
3.7 alcohol precipitation process orthogonal optimization test factor level table of table
Use L9(33) the optimization experiment of orthogonal trial alcohol precipitation process, specific experiment arrangement such as table 3.8.
3.8 alcohol precipitation orthogonal design table of table
The range analysis of 3.9 alcohol precipitation process orthogonal experiment of table
It is tested according to table 3.8, obtains 1-9 sample, it is scored with yield of extract scoring and Determination of forsythin respectively The comprehensive score of sum is inspection target, and data are shown in Table 3.9.By very poor R value size it is found that influencing the factor primary and secondary of comprehensive score Sequentially are as follows: B (medicinal extract density) > A (concentration of alcohol) > C (time of repose).Therefore A is chosen2B3C3Factor level as the party solve Alcohol precipitation process, that is, determine alcohol precipitation optimum process are as follows: it is 1.1 that extracting solution, which is concentrated into density, alcohol precipitation concentration 70%, when standing Between be 24 hours.
The verifying of 3.5 alcohol precipitations experiment optimal conditions
Three parts of five kinds of total 50g of prescription medicine are weighed, are tested by best alcohol precipitation process, verification result is shown in Table 3.10.
3.10 alcohol precipitation process confirmatory experiment result of table
Three times in experiment in dry extract Determination of forsythin relative standard deviation RSD=0.94% < 3%, in desired model In enclosing, show that the optimum extraction process is stable, reliable, determines that the technique is the best alcohol precipitation process of Chinese medicinal granule of the invention. The alcohol precipitation process condition screened is basicly stable.
The research of 3.6 drying process
Hot air circulation is dry, vacuum drying is the common drying means of Chinese medical concrete, by comparing drying efficiency and yield, Drying means is screened.
The medicinal extract of 2 batches (20170711,20170712) in alcohol precipitation verification test is taken, is carried out with different drying means It investigates.
3.11 drying process experimental result of table
Experimental result is as shown in table 3.11, and vacuum drying moisture loss amount is small, and drying time is moderate, and moisture content is easily-controllable System, therefore the drying means of this product selects vacuum drying.
The research of 4 preparation process
Our quantity is daily 50g crude drug amount, and such as in terms of yield of extract 10%, then each dry extract dose is about 5g, therefore the granule for selecting drugloading rate big is we into pharmaceutically dosage form.
The research of 4.1 prescription screenings
4.1.1 auxiliary material screens
Dry extract is beaten into powder, 80 meshes is crossed, is divided into 6 parts, every part of 10g.Different auxiliary material is added by table 4.1, mixes, 75% Ethyl alcohol is as wetting agent, and dry, whole grain investigates its appearance character, melting, and mobility evaluates particle.
The investigation of melting: by being provided under the version one of Chinese Pharmacopoeia 2010 (annex IC), not due to this product packing specification Fixed, so temporarily taking 2g, precision weighs 2g particle, is placed in dry into the 80mL beaker of constant weight, heating water 80ml, 5 points of stirring Clock is observed immediately, if is suspended uniform.
The investigation of mobility: angle of repose (ReposeAngle), also known as angle of rest (repose) refer to that material is accumulated to be formed in horizontal plane Angle between material heap surface and horizontal plane, for measuring the mobility of powder.
4.1 auxiliary material screening test of table (unit: g)
From granulation eveluatin interpretation of result: the addition of soluble starch keeps its ratio of briquetting lower, does not meet National Pharmacopeia Regulation, and dextrin and lactose all meet National Pharmacopeia requirement in ratio of briquetting, melting and mobility.And dextrin: lactose=3: When 2 ratio, particle moderate viscosity is easily molded, and melting and mobility are preferable.Therefore use dextrin and lactose as figuration Agent.
4.1.2 adhesive screens
Dry extract is beaten into powder, 80 meshes is crossed, is divided into 4 parts, does not have a part 10g.6g dextrin and 4g lactose are added simultaneously, and both are auxiliary Material mixes, different adhesives is added, dry, whole grain, investigates its particle proterties, melting, three factors of mobility to Grain is evaluated.
4.2 adhesive screening test of table (unit: g)
As shown in table 4.2, the results showed that it is more preferable than with 75% ethyl alcohol effect using 95% ethyl alcohol, it prompts in this prescription Use water less as far as possible, in order to avoid agglomeration.10% vinylpyrrolidone K30-95% ethanol solution is selected to make according to this prescription of test result For the adhesive of this prescription.
4.2 Study on Preparation
4.2.1 different incorporation time medicament contg uniformity testings
Mixing apparatus: the type high-shearing granulation machine of Changzhou Fan Shi drying equipment Co., Ltd, capacity 5L.
Prescription: dry extract 500g；Dextrin 300g；Lactose 200g；
Total amount 1kg
Test method: the dry extract and dextrin of recipe quantity is added, in granulation pot with main stirring 300rpm and cutter After mixing 1 minute under 500rpm speed, the lactose of recipe quantity is then added, with main stirring 300rpm and cutter 500rpm speed The lower mixing of degree, stopped stirring, 3 different parts on material surface layer respectively take 3g sample respectively at 5,7.5 and 10 minutes respectively Product, middle part takes 3g sample in middle level, respectively takes 3g sample at the different position in bottom 3, is connected in HPLC chromatogram method measurement sample The content for sticking up glycosides, the results are shown in Table 4.3.
The different incorporation time medicaments uniformity degree test results of table 4.3
Test result is shown, at main stirring 300rpm and cutter 500rpm velocity conditions, 5,7.5 and 10 minutes whens connect The RSD for sticking up the content of glycosides is 2.92%, 2.37% and 1.87%, is illustrated with main stirring 300rpm and cutter 500rpm speed Lower mixing, the Determination of forsythin uniformity is preferable in particle when stopping stirring after 10 minutes, therefore selects incorporation time for 10 points Clock.
4.2.2 the test that different clipping times influence softwood performance
It is three by above-mentioned uniformly mixed material portion, at main stirring 300rpm and cutter 1500rpm velocity conditions, PVPK30-95% alcohol slurry is added, investigates influence of the different clipping times to softwood form, softwood is through the wet whole grain of 14 meshes, warp 60 DEG C drying 2 hours, measure pellet moisture and mobility.
The test result that the different clipping times of table 4.4 influence softwood
In table 4.4 the results show that at main stirring 300rpm and cutter 1500rpm velocity conditions, after cutting 10min, Particle is neither too hard, nor too soft, easily molded, and color is consistent, and particle is uniform, therefore clipping time selects 10min.
5 conclusions
This part carries out preliminary screening by pharmacodynamic test, to the extraction solvent and technique of party's solution.Finally determine this hair The extracting method of bright Chinese medicinal granule is water extraction and alcohol precipitation method.Party's solution has been carried out respectively by Three factors-levels orthogonal experiment Extraction process by water and alcohol precipitation process optimization.Dry, granulation work is determined to by hydraulic test and primary stability simultaneously Skill；Test is compared using atmosphere pressure desiccation, hypobaric drying method；Parllel screening, skill are carried out using wet granulation method simultaneously Art index is respectively mobility, melting, angle of repose and yield, establishes grain forming method.
Finally determine the best extraction process by water of Chinese medicinal granule of the invention are as follows: it extracts 2 times, each decocting time is 2 hours, 8 times of amount of water, the average content of forsythin is 0.2339% in parallel verified test gained dry extract three times under the process conditions, Medicinal extract average yield is 24.93%, RSD=1.19%.
The best alcohol precipitation process of Chinese medicinal granule of the invention are as follows: 70% ethyl alcohol, time of repose are 24 hours, extracting solution concentration It is 1.1 to density, forsythin is averaged in gained dry extract in parallel verified test gained extracting solution three times under the process conditions Content is 16.57%, and medicinal extract average yield is 0.3889%, RSD=0.94%.
Finally determine the drying process of the prescription using vacuum drying method.Select dextrin and lactose as the prescription Auxiliary material (additional proportion is dextrin: lactose=3:2) and -95% ethanol solution of 10% PVP K30 are as this place The adhesive of side.By the granulating process research to prescription particle, primarily determine as the dry leaching of recipe quantity is added in granulation pot Then the cream of recipe quantity is added after mixing 1 minute under main stirring 300rpm and cutter 500rpm speed in cream powder and dextrin Sugar stopped stirring, in main stirring to mix under main stirring 300rpm and cutter 500rpm speed at 10 minutes respectively Under 300rpm and cutter 1500rpm velocity conditions, PVPK30-95% alcohol slurry is added, softwood is through the wet whole grain of 14 meshes, warp 60 DEG C of dryings.
Chinese medicinal granule of the invention is prepared by the process route and process conditions of above-mentioned optimization.
The identification of 11 drug standard of embodiment
In the present embodiment identification and assay used in control substance of plant drug it is as follows:
Andrographolide
[molecular formula] C20H30O5
[molecular weight] 350.44
[physicochemical property] white side's prismatic or flaky crystal (ethyl alcohol or methanol), odorless, bitter.It is dissolved in boiling ethyl alcohol, Slightly molten in methanol or ethyl alcohol, atomic to be dissolved in chloroform, almost insoluble in water or ether, fusing point is 230~231 DEG C.
Source: National Institute for Food and Drugs Control
Forsythin
[molecular formula] C27H34O11
[molecular weight] 534.56
[physicochemical property] white crystalline powder.184 DEG C~185 DEG C of fusing point, it is dissolved in ethyl alcohol, does not dissolve in ether, hexane and chlorine It is imitative.
Source: National Institute for Food and Drugs Control
Herba Andrographitis control medicinal material
Identification is purchased from National Institute for Food and Drugs Control with control medicinal material lot number 121082-201505
Dandelion control medicinal material
Identification is purchased from National Institute for Food and Drugs Control with control medicinal material lot number 120928-201208
Fructus Forsythiae control medicinal material
Identification is purchased from National Institute for Food and Drugs Control with control medicinal material lot number 120908-201216
Our totally 5 taste medicine has carried out wherein dandelion, Herba Andrographitis and Fructus Forsythiae using thin-layered chromatography to identify research, side Method is as follows:
1 identifies
1) experimental material and instrument
5.1 experimental material of table
5.2 laboratory apparatus of table
2) thin layer of Herba Andrographitis identifies
The preparation of test solution
Precision weighs Pu Lian removing summer-heat dry extract (lot number 20170714) sample about 5.0004g, finely ground, adds ethyl alcohol 30ml, surpasses Sonication 30 minutes, filtration, filtrate was concentrated into 5ml, as test solution.
The preparation of negative control solution
Precision, which weighs, lacks medicinal extract 4.9996g made from Herba Andrographitis medicinal material, is made in the same way of negative control solution.
The preparation of control medicinal material solution
Herba Andrographitis control medicinal material 0.5g is weighed, control medicinal material solution is made in the preparation method with above-mentioned test solution.
Reference substance solution preparation
Precision weighs andrographolide standard items 0.0130g, adds dehydrated alcohol to dissolve and is settled to 10mL, shakes up to obtain the final product The punching of 1.0mg/mL connects lactone solution.
It is tested according to thin-layered chromatography, draws test sample, negative controls solution and each 6 μ L of control medicinal material solution and reference substance 4 μ L of solution is put respectively on same silica gel g thin-layer plate, with chloroform-acetate-methanol (4:3:0.4) for solvent, Expansion takes out, dries, set and inspect under ultraviolet lamp (254nm).Its result is as shown in Figure 1.It is and right in sample chromatogram According to the identical band of color on the corresponding position of product chromatography, is shown, feminine gender is noiseless herein.Preferably, expansion is imitated for sample strip separation Fruit is preferable, is taken in quality standard.
3) thin layer of dandelion identifies
The preparation of test solution
Precision weighs Pu Lian removing summer-heat dry extract (lot number 20170714) sample about 2.0020g, adds the methanol solution of 5% formic acid 20ml is ultrasonically treated 20min, filtration, and filtrate is evaporated, and residue adds water 10ml to make to dissolve, and filtration, filtrate is shaken with ethyl acetate It extracts 2 times, each 10ml, combined ethyl acetate liquid is evaporated, and residue adds methanol lmL to make to dissolve, as test solution.
The preparation of negative control solution
Precision, which weighs, lacks medicinal extract 2.0010g made from dandelion medicinal material, is made in the same way of negative control solution.
The preparation of control medicinal material solution
Dandelion control medicinal material 1.0g is weighed, control medicinal material solution is made in the preparation method with above-mentioned test solution.
It is tested according to thin-layered chromatography, draws above-mentioned each 6 μ l of four kinds of solution, put respectively on same silica gel g thin-layer plate, with second Acid butyl ester-formic acid-water (7:2.5:2.5) upper solution is solvent, is unfolded, and takes out, dries, set ultraviolet lamp (365nm) Under inspect.
Its result is as shown in Figure 2.In sample chromatogram, on position corresponding with reference substance chromatography, it is identical to show color Band, it is negative noiseless herein.Preferably, expansion effect is preferable for sample strip separation, is taken in quality standard.
4) thin layer of Fructus Forsythiae identifies
The preparation of test solution
Precision weighs Pu Lian removing summer-heat dry extract (lot number 20170710) sample about 3.0045g, finely ground, is placed in 100ml round bottom In flask, methanol 20ml is added, is heated to reflux 1h, filters, filtrate is concentrated into 1ml, as test solution.
The preparation of negative control solution
Precision, which weighs, lacks medicinal extract 3.0012g made from Fructus Forsythiae medicinal material, is made in the same way of negative control solution.
The preparation of control medicinal material solution
Fructus Forsythiae control medicinal material 1.0g is weighed, control medicinal material solution is made in the preparation method with above-mentioned test solution.
Reference substance solution preparation
Precision weighs forsythin standard items 0.0025g, adds dehydrated alcohol to dissolve and is settled to 10mL, shakes up to obtain the final product The forsythin solution of 0.25mg/mL.
It is tested according to thin-layered chromatography, draws above-mentioned each 5 μ L of 4 kinds of solution, put respectively on same silica gel g thin-layer plate, with three Lower layer's solution of chloromethanes-methanol-water (14:6:1) is solvent, is unfolded, and takes out, dries, and spray is with vanillic aldehyde test solution, 105 DEG C It is clear to be heated to spot development.
Its result is as shown in Figure 3.In sample chromatogram, on position corresponding with reference substance chromatography, same color is shown Band, it is negative noiseless herein.Preferably, expansion effect is preferable for sample strip separation, is taken in quality standard.
2 assays
Totally 5 kinds of medicinal materials form this product prescription, using HPLC chromatogram method to wherein with the Fructus Forsythiae of good carbuncle that disappears dissipating bind effect Assay research has been carried out, content assaying method has finally been taken in into drug standards text.
1) HPLC measures the content of forsythin in prescription
Chromatographic condition
Chromatographic column uses AgilentC18 column (4.6mm × 250mm, 5 μm), using acetonitrile-water as mobile phase (25:75), etc. Degree elution, flow velocity 1.0mL/min；Detection wavelength is 277nm, 35 DEG C of column temperature, 10 μ L of sample volume.
The preparation of solution
The preparation of reference substance solution
Precision weighs forsythin reference substance 2.0mg and sets in 10mL volumetric flask, and addition methanol is appropriate, and dissolution, constant volume shakes up To obtain the final product.
The preparation of test solution
Precision, which weighs, takes test sample 2.0008g, sets in tool plug flask, adds 80% methanol solution 20mL, accurately weighed, ultrasound Extract 30min, mend weight to get.
The preparation of negative controls solution
The negative controls for lacking Fructus Forsythiae are prepared by the preparation process of the granule, then press the preparation method of test solution It is operated with method, obtains negative controls solution.
Using this chromatographic condition, the retention time of forsythin is 12.206min.To prescription sample, lack Fructus Forsythiae negative sample Sample introduction is distinguished with reference substance.As a result, the separating degree of forsythin is good, it is negative noiseless on the chromatography peak position of forsythin, See chromatogram 4.Calculating gained Determination of forsythin is 2.004mg/g.
2) methodology validation
Linear relationship investigates experiment
2,5,10,15,18, the 20 μ L sample introduction of forsythin reference substance solution for taking 0.20mg/mL respectively, by the above chromatostrip Part is measured, and using peak area as ordinate, sample volume is abscissa, draws standard curve, as shown in Figure 5.Linear regression side Journey is y=117.14x-57.204, R2=0.9999, the results showed that forsythin sample volume in 0.4-4.0 μ g range with peak face Product linear relationship is good.
Precision Experiment
It is 0.200mg/mL forsythin reference substance solution that precision, which draws concentration, and METHOD FOR CONTINUOUS DETERMINATION 6 times, each 10 μ L of sample introduction is pressed Above method measurement, the peak area RSD for calculating forsythin is 0.53% (n=6), shows that instrument precision is good.
Repeated experiment
Take that (lot number: 20170601) 6 parts of test sample, every part of 1.0g is accurately weighed, by the method for solution preparation in " (1) " Preparation is filtered with 0.22 μm of miillpore filter, is measured, and the average content for measuring forsythin is 2.004mgg-1, RSD For 0.45% (n=6), show that method repeatability is good.
Stability experiment
Precision draw (lot number: the 10 μ L of same test solution of sample preparation 20170601), respectively 0,2,4,8, 12, sample detection for 24 hours, the RSD for obtaining forsythin peak peak area is 0.23%, shows that test solution is good in internal stability for 24 hours It is good.
Sample recovery rate test
Precision weigh (lot number: 6 parts, every part of 0.5g of sample (Determination of forsythin: 2.004mgg-1) 20170601), point The inaccurate forsythin reference substance that is added is appropriate, and test solution is made by method below " (1) " item, measures according to chromatographic condition, counts Calculate the average recovery rate and RSD of forsythin.It the results are shown in Table 6.
6 sample recovery rate test result (n=6) of table
12 pharmacodynamic experiment of embodiment (one)
This test carries out Pharmacodynamics research to the clearing heat and detoxicating of our Chinese medicine composition extract, anti-inflammatory effect.
1, test material
1.1 test drug
The traditional chinese medicine composition of the invention extract
Content: crude drug containing 3.125g/g
Physicochemical property: dark brown clear cream
Stability: stablize
Validity period: 2 years
Preservation condition: 4 DEG C of cold compartment of refrigerator are placed.
Application notice: it is refrigerated behind Kaifeng
Unit: Shanghai City Hospital of Skin Diseases is provided
It prepares: being configured to the tested medical fluid of required concentration with distilled water solution.
1.2 positive control drug
1) aspirin enteric coated tablet, Bayer HealthCare Co's production, specification 100mg/ piece, lot number BJ33895.
2) sour, Irish Leo Pharma A/S in western husband ground, lot number A82103
3) hydrocortisone, Tianjin Kingyork Pharmaceutical Co., Ltd.'s production, specification: 5ml:25mg, batch number 1801161
1.3 reagents and bacterial strain:
1) plum mountain high activity dried yeast, the production of Hebei horsepower Food Co., Ltd.Lot number: 89423
2) staphylococcus aureus reference culture ATCC29213
3) dimethylbenzene, Shanghai Run Jie chemical reagent Co., Ltd, AR grades, lot number 20170301.
1.4 key instruments and model
1.4.1 electronic balance QUINTIX3102 type, Sai Duolisi product
1.4.2 electronic thermometer MC-347 type, the production of Omron (Dalian) Co., Ltd
1.4.3 Maxwell is than turbid instrument TA-2XJB type, Beijing Tian An joint Science and Technology Ltd.
1.5 experimental animal
1.5.1SD rat
Male, 220~250g, SPF grade, the western Poole Bi Kai experimental animal Co., Ltd in Shanghai provide, experimental animal production Credit number: SCXK (Shanghai) 2013-0016；
1.5.2ICR mouse
Male, 19~22g, SPF grade, the western Poole Bi Kai experimental animal Co., Ltd in Shanghai provide, and experimental animal production is permitted It can the number of card: SCXK (Shanghai) 2013-0016；
1.5.3 Albino guinea pig
Male and female dual-purpose, 250~280g, regular grade, Shanghai Jia Gan Biotechnology Co., Ltd provide, and experimental animal production is permitted It can the number of card: SCXK (Shanghai) 2015-0005
1.6 rearing conditions and adaptive feeding time
Raising farm: Shanghai City hospital, Pudong medical research and innovation center's animal house
Rearing conditions and environment: the real face room raising of SPF grade the 4th, 20~24 DEG C of temperature, humidity 40%-60%, noise≤60 Decibel, rate of ventilation >=15 time hour, the work bright 12h of illumination 12h are dark.The free diet of mouse, drinking-water, change water 1 time for 1~2 day, and 1 Change 1-2 padding week.
The adaptive feeding time: 2 days of adaptive feeding after animal enters the room
1.7 feed titles or code name, conditions of water drinking
Feed title: SPF grades of mouse material (Co60 irradiation).
There is provided unit: Beijing Australia, section pulls together feed corporation,Ltd
Feed predominantly detects project and result: feed nutrition quality testing and sterility test quality inspection report proof are Qualified
Drinking water situation: water factory provides, high pressure sterilization.
Padding situation: wood shavings padding.
2, test method
The test of 2.1 rat fevers:
It SD rat 60, tests first 3 days, measures anus temperature with electric body-temperature meter daily, answered caused by measuring anus temperature with eliminating Swash reaction, and records each mouse normal body temperature.The rat that 38.0 DEG C of single body temperature > or 3 anus temperature fluctuate 0.3 DEG C of > is eliminated.Choosing Take qualified rat totally 54, be randomly divided into 6 groups: blank control group, model group, Chinese medicine composition extract be low, in, High dose group, aspirin group, every group each 9, fasting 12h before testing, can free water.Remaining is each in addition to blank control group 10% yeast suspension 1mL/100g is subcutaneously injected with pyrogenicity in group rat back.
Medication: blank control group and model group stomach-filling distilled water；Remaining groups of animals gives relative medicine stomach-filling, real Test low middle high dose 1.5g/kg, 3g/kg, 4.5g/kg, aspirin group 0.3g/kg.0.5 hour dorsal sc note after stomach-filling Female suspension is penetrated, (mode and dosage are with for the first time) is administered within 5 hours after modeling again.And measure administration after 1,2,3,4,6,8, 10, the 12, Temperature changing after 15h, as effect index.
The test of 2.2 cavy yang syndrome sores:
Regular grade cavy 42, be randomly divided into 6 groups by weight, every group 7, respectively as blank control group, model group, The high, medium and low dosage group of Fusidic Acid group, Chinese medicine composition extract.The preparation of yang syndrome sore animal model method particularly includes: Cleaning grade cavy 24, weight about 250-300g are taken, is randomly divided into 4 groups, every group 6.Experiment bacterial infection is golden yellow grape Coccus.It experiment the previous day, takes lawn a little with oese the bacterial strain of preservation, is inoculated on culture medium, cultivate 18 through 37 DEG C Hour, as infectious bacteria.Experiment the previous day becomes mildewed cavy chest and abdomen back cutting, is then applied to undercoat area with depilatory agent, and Hair removal section, which applies suitable liquid paraffin, prevents chapped skin.When next day tests, figure is cut in hair removal section with sterile working program One piece of skin, every cavy makes the surface of a wound that area is about 1 square centimeter, and surface of a wound bottom, which can be subject to, sees sarolemma, if wound has Oozing of blood, with sterile cotton balls Pressur hemostatic.In the Staphylococcus aureus 0.5ml that each surface of a wound implantation concentration is 900,000,000/ml, infection system Make positive Sore model, is wrapped up afterwards with gauze flap coverage with medical proof fabric.Back hair is removed with electric hair cutter and depilatory cream, Area about 4cm × 4cm, the staphylococcus aureus bacterium of groups of animals intracutaneous injection volume 300ul is outstanding in addition to blank control group Liquid, containing about 1,500,000,000 or so staphylococcus aureuses.Experiment is Staphylococcus aureus with bacterial infection, experiment the previous day, will be saved Bacterial strain take lawn a little with oese, be inoculated on LB culture medium, through 37 DEG C of 18 hours of culture, as infectious bacteria.In There are obvious red bumps compared with blank control group in 2 days observation guinea pig backs, illustrate modelling success.
Administration group cavy (is converted) with Chinese medicine composition extract various dose gastric infusion by people's dosage, i.e., low, Middle and high dosage group 1.5g/kg, 3g/kg, 4.5g/kg, stomach-filling volume are 10ml/kg, and gastric infusion 2 times, continue 7 in 24 hours It.Blank control group, model group give isometric physiological saline by weight.The band for being 200ml per daily capacity since administration The feeding bottle of scale feeds water to cavy, observes and records the amount of drinking water of cavy.Sore face situation is observed, and is taken pictures with digital camera. Behavior observation specifically includes that the case where daily routines, excreta, average appetite, local infection.Observe treatment condition, chilly hair Enthusiastic condition, wound healing situation, the death rate and the observation of model sore tissue pathological slice.
2.3 mouse auricle swelling tests:
ICR mouse 60,19~22g of weight is randomly divided into 5 groups, every group 12, i.e., Chinese medicine composition extract it is low, in, High dose group 3g/kg, 4.5g/kg, 6g/kg, hydrocortisone group 15mg/kg, blank control group (are given in equal volume by weight Physiological saline)；The equal gastric infusion of each group, stomach-filling volume be 20ml/kg, 2 times/d, continuous 7d.30min after the last administration is used Micro sample-adding rifle takes off neck after mouse right ear tow sides each uniform smearing xylene solution 25uL, 30min and puts to death, and cuts double Ear, the stainless steel punching pin for the use of diameter being 8mm, sweeps away left and right auricle, weighs in electronic balance.With left and right sides auricle weight Index of the difference as swelling degree, anti-inflammatory effect intensity are indicated using swelling (rag) and swelling inhibiting rate (%).
3, statistical method used by data is analyzed:
With t value method when two comparison among groups variances are neat, the t value method of correction when heterogeneity of variance.
4, test result
The test of 4.1 rat fevers:
0.5 hour dorsal sc injection ferment after Chinese medicine composition extract low, middle and high dose groups, aspirin group stomach-filling (mode and dosage are with for the first time) is administered for 5 hours after modeling in female suspension again；The basic, normal, high dosage of Chinese medicine composition extract (1.5g/kg, 3g/kg, 4.5g/kg) organizes animal heat and increases variation respectively less than model group.Wherein 1.5g/kg, 3g/kg dosage group 4 hours after administration, 6 hours, 8 hours after 4.5g/kg administration when Temperature changing value and model group ratio, with statistical significance (p < 0.05~0.01).This test display: Chinese medicine composition extract of the invention can reduce the rising of body temperature caused by yeast.Knot Fruit is shown in Table 7.
Influence of the 7 each group medication of table to dry ferment pyrogenicity rat temperature
(X scholar SD, n=9)
* p < 0.01 p < 0.05, * * is compared with model group
The test of 4.2 cavy yang syndrome sores:
4.2.1 zoomorphism is observed
Modeling the 2nd day, the visible groups of animals hair removal section visible color in addition to blank control group of observation each group guinea pig skin was red, bright Heat, high prominent lump are touched pain and are cried, this feature, which meets clinical yang syndrome, takes and raise " red, swollen, hot, pain " performance.
4.2.2 drinking water for animals amount, survival rate observation
After animal model amount of drinking water increase, through the traditional chinese medicine composition of the invention extract gastric infusion 2 times a day, continuous 7 days, Low middle high and blank control group, model group, positive drug group animal survival number 2,3,3,7,1,3.Medication group is deposited Number living is obviously more than model group survival number.It the results are shown in Table 8.
Influence of the 8 each group medication of table to Sore model survival rate caused by S. aureus L-forms
(x scholar SD, n=7)
* p < 0.05, compared with model comparison
4.2.3 lump dermal pathology form compares
Blank control group: skin epidermis and dermis are complete, horny layer of epidermis, hyaline layer, stratum granulosum, stratum spinosum epidermidis, Clear, the structural integrity of basal layer boundary, has no that ulcer is formed, epidermal cell has no oedema, necrosis and falls off.Papillary layer of corium And lamina reticularis is clear in structure, blood vessel has no congested, expansion.
Model group: skin epidermis integrality is interrupted, and ulcer is formed, and skin surface is bled profusely, and lower section is more bad Dead tissue, a large amount of neutrophil infiltrations are arranged at bottom.
The sour group in western husband ground: epidermis and dermal structure is complete, the visible sebaceous glands of skin corium, hair follicle and sweat gland.Corium deep layer is shown in few Inflammatory cell infiltration is measured, is dispersed in a small amount of bleeding, fibroblast and histiocytosis, granulation tissue is formed.
Chinese medicine composition extract low dose group: skin epidermis integrality is interrupted, and there is bleeding on surface, and lower section is necrosis region, A large amount of neutrophil infiltrations, form microabscess, histiocytosis, and granulation tissue is formed on a small quantity.
Chinese medicine composition extract middle dose group: epidermis is complete, slightly thickens, and is by the visible small hemorrhagic focus of corium deep layer Lesser necrosis region, and see the microabscess that a large amount of neutrophil accumulations are formed, the visible more granulation tissue of surrounding is formed.
Chinese medicine composition extract high dose group: epidermis is complete, slightly thickens, and the visible a small amount of neutral grain of corium deep layer is thin Born of the same parents' infiltration, forms microabscess, and the visible a large amount of granulation tissues of surrounding are formed.
As a result see Fig. 6-17.
4.3, mouse auricle swelling test:
It gavages Chinese medicine composition extract to gavage within continuous 7 days 2 times a day, can obviously inhibit Mice Auricle caused by dimethylbenzene The mice auricle swelling rate reduction compared with model group of swelling, Chinese medicine composition extract middle dose group and positive controls has Significant difference (P < 0.05), the results are shown in Table 9.
The influence (x scholar SD, n=12) of 9 each group medication paraxylene induced mice auricle swelling of table
* p < 0.05, compared with blank control
5, it discusses
Rat fever model can be successfully, reproduced by dorsal sc injection dry ferment suspension；Chinese medicine composition extract High, medium and low dosage group has refrigeration function to dry ferment pyrogenicity rat model, wherein Chinese medicine composition extract high dose group Effect is best, and refrigeration function is analyzed from Temperature changing mainly may be by reducing body temperature rising peak and in advance height What peak plateau phase was realized in turn.
Yang syndrome sore acute inflammation animal model caused by S. aureus L-forms is selected, the symptom of clinical application, tissue disease are simulated Reason has prompted Chinese medicine composition extract of the invention to have the healing for promoting the inflammation open sore part.Pass through dimethylbenzene induced mice auricle Swelling test equally demonstrates Chinese medicine composition extract of the invention with certain anti-inflammatory effect.
6, brief summary
Rats gavaged Chinese medicine composition extract twice a day, in 1.5~4.5g/kg dosage range, can reduce rat ferment The raised effect of body temperature caused by mother, wherein it is most significant to gavage effect with 4.5g/kg dosage.
Cavy gavages Chinese medicine composition extract twice a day, continuous 7 days, in 1.5~4.5g/kg dosage range, can promote Into the healing of yang syndrome sore caused by S. aureus L-forms, wherein it is preferable to gavage effect with 4.5g/kg dosage.
Mouse gavaging takes traditional Chinese medicine composition extract twice a day, continuous 7 days, can mitigate auricle swelling caused by dimethylbenzene, It is wherein then acted on when 4.5g/kg dosage particularly significant.
7, conclusion
On two clearing heat and detoxicating models and dimethylbenzene induced mice auricle swelling model, Chinese medicine composition of the invention is filled The raised effect of body temperature caused by specific anti-yeast is shown after clothes and with certain anti-inflammatory effect.The body caused by anti-yeast Temperature increases on rat model, and effective dose is respectively 2~4.5 extract g/kg.It is of the invention in this dosage range Chinese medicine composition extract shows the raised effect of antibody temperature.Upper Chinese medicine composition extract is tested in yang syndrome Sore model The sore healing of high dose is significantly better than blank control group, these test results show that Chinese medicine composition of the invention extracts Object has apparent clearing heat and detoxicating and anti-inflammatory activity.
13 pharmacodynamic experiment of embodiment (two)
This test carries out main pharmacodynamics to the clearing heat and detoxicating of Chinese medicine composition extract of our different ratio, anti-inflammatory effect Learn research.
1, test material
1.1 test drug
The preparation method according to the invention preparation of the Chinese medicine material medicine of Example 1-4 respectively obtain drug one, drug two, Drug three, drug four.
Content: each drug contains 3.125g crude drug/g
Physicochemical property: dark brown clear cream
Stability: stablize
Validity period: 2 years
Preservation condition: 4 DEG C of cold compartment of refrigerator are placed.
Application notice: it is refrigerated behind Kaifeng
Unit: Shanghai City Hospital of Skin Diseases is provided
It prepares: being configured to the tested medical fluid of required concentration with distilled water solution.
1.2 experimental animal
1.2.1ICR mouse
Male, 19~22g, SPF grade, the western Poole Bi Kai experimental animal Co., Ltd in Shanghai provide, and experimental animal production is permitted It can the number of card: SCXK (Shanghai) 2013-0016；
1.2.2 Albino guinea pig,
Male and female dual-purpose, 250~280g, regular grade, Shanghai Jia Gan Biotechnology Co., Ltd provide, and experimental animal production is permitted It can the number of card: SCXK (Shanghai) 2015-0005
1.3 rearing conditions and adaptive feeding time
Raising farm: Shanghai City hospital, Pudong medical research and innovation center's animal house
Rearing conditions and environment: the real face room raising of SPF grade the 4th, 20~24 DEG C of temperature, humidity 40%-60%, noise≤60 Decibel, rate of ventilation >=15 time hour, the work bright 12h of illumination 12h are dark.The free diet of mouse, drinking-water, change water 1 time for 1~2 day, and 1 Change 1-2 padding week.
The adaptive feeding time: 2 days of adaptive feeding after animal enters the room
1.4 feed titles or code name, conditions of water drinking
Feed title: SPF grades of mouse material (Co60 irradiation).
There is provided unit: Beijing Australia, section pulls together feed corporation,Ltd
Feed predominantly detects project and result: feed nutrition quality testing and sterility test quality inspection report proof are Qualified
Drinking water situation: water factory provides, high pressure sterilization.
Padding situation: wood shavings padding.
2, test method
The test of 2.1 cavy yang syndrome sores:
Regular grade cavy 45, be randomly divided into 5 groups by weight, every group 9, respectively as blank control, one group of experiment, Test two groups, three groups of experiment, four groups of experiment.The preparation of yang syndrome sore animal model method particularly includes: take cleaning grade cavy, body Weigh about 250-300g.Experiment is Staphylococcus aureus with bacterial infection.Experiment the previous day, the bacterial strain of preservation is taken with oese Lawn is a little, is inoculated on culture medium, through 37 DEG C of 18 hours of culture, as infectious bacteria.Experiment the previous day, by cavy chest and abdomen Cutting of becoming mildewed is carried on the back, is then applied to undercoat area with depilatory agent, and apply suitable liquid paraffin in hair removal section to prevent chapped skin.It is secondary When day experiment, one piece of graphical skin is cut in hair removal section with sterile working program, it is about 1 square li that every cavy, which makes area, The surface of a wound of rice, surface of a wound bottom, which can be subject to, sees sarolemma, if wound has oozing of blood, with sterile cotton balls Pressur hemostatic.It is infused in each surface of a wound Enter the Staphylococcus aureus 0.5ml that concentration is 900,000,000/ml, infection makes positive Sore model, afterwards with gauze flap coverage to cure It is wrapped up with adhesive plaster.Back hair is removed with electric hair cutter and depilatory cream, area about 4cm × 4cm, each group is dynamic in addition to blank control group The staphylococcus aureus bacteria suspension of object intracutaneous injection volume 300ul, containing about 1,500,000,000 or so staphylococcus aureuses.Experiment is used Bacterial infection is Staphylococcus aureus, experiment the previous day, takes lawn a little with oese the bacterial strain of preservation, is inoculated in LB training It supports on base, through 37 DEG C of 18 hours of culture, as infectious bacteria.Occur obviously in the 2nd day observation guinea pig back compared with blank control group Red bumps illustrate modelling success.
It tests one group, two groups of experiment, three groups of experiment, test four groups of cavys respectively with one, two, three, four same dose of drug Gastric infusion (is converted) by people's dosage, and dosage is 3g/kg, and gastric infusion 2 times in 24 hours continue 7 days.Blank pair Isometric physiological saline is given by weight according to group.Feeding bottle with a scale since administration per daily capacity for 200ml is to globefish Mouse feeds water, observes and records the amount of drinking water of cavy.Sore face situation is observed, and is taken pictures with digital camera.Behavior observation mainly wraps It includes: the case where daily routines, excreta, average appetite, local infection.Observation treatment condition, chilly heat condition, the open sore part are cured Close situation, the death rate and the observation of model sore tissue pathological slice.
2.2 mouse auricle swelling tests:
ICR mouse 60,19~22g of weight is randomly divided into 5 groups, every group 12, that is, tests one group, two groups of experiment, experiment Three groups, experiment four groups, blank control group (giving isometric physiological saline by weight)；The equal gastric infusion dosage of each group is 4.5g/kg, 2 times/d, continuous 7d.30min after the last administration, it is each uniformly in mouse right ear tow sides using micro sample-adding rifle Xylene solution 25uL is smeared, neck is taken off after 30min and puts to death, cut ears, the stainless steel punching pin for the use of diameter being 8mm sweeps away a left side Auris dextra piece is weighed in electronic balance.Using left and right sides auricle weight difference as the index of swelling degree, anti-inflammatory effect intensity makes It is indicated with swelling (rag) and swelling inhibiting rate (%).
3, statistical method used by data is analyzed:
With t value method when two comparison among groups variances are neat, the t value method of correction when heterogeneity of variance.
4, test result
4.1 cavy yang syndrome sore test results are shown in Table 10.
Influence of the 10 each group medication of table to Sore model survival rate caused by S. aureus L-forms
(x scholar SD, n=9)
4.2, mouse auricle swelling test result:
It gavages Chinese medicine composition extract to gavage within continuous 7 days 2 times a day, can obviously inhibit Mice Auricle caused by dimethylbenzene The mice auricle swelling rate reduction compared with model group of swelling, Chinese medicine composition extract middle dose group and positive controls has Significant difference (P < 0.05), the results are shown in Table 11.
The influence of 11 each group medication paraxylene induced mice auricle swelling of table
(x scholar SD, n=12)
5 conclusions
It is apparent clearing heat and detoxicating and anti-that above-mentioned test result shows that the Chinese medicine composition extract under present invention proportion has Scorching activity.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art Member, without departing from the principle of the present invention, can also make several improvement and supplement, these are improved and supplement should also regard For protection scope of the present invention.

Claims (9)

1. a kind of Chinese medicine composition for treating suppurative dermatosis, which is characterized in that the composition is by such as the following parts by weight Bulk pharmaceutical chemicals are made: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane.
2. Chinese medicine composition according to claim 1, which is characterized in that be made according to Chinese medicine customary preparation methods and clinically may be used The pharmaceutical preparation of receiving.
3. application of the Chinese medicine composition described in claim 1 in the drug of preparation treatment suppurative dermatosis.
4. being applied according to right 3, which is characterized in that the suppurative dermatosis be acne, impetigo, epifolliculitis, furuncle, Carbuncle, erysipelas.
5. a kind of Chinese medicinal granule for treating suppurative dermatosis, which is characterized in that the Chinese medicinal granule as described in claim 1 in Drug composition is made, and the preparation method of the Chinese medicinal granule includes the following steps:
(1) water mentions twice: the bulk pharmaceutical chemicals of parts by weight: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane such as weigh, every time plus Water is 8 times of bulk pharmaceutical chemicals total weight, is decocted 2 times, 2 hours every time, collecting decoction, filtration obtained filtrate；
(2) alcohol precipitation: it is 1.2 that the filtrate decompression that step (1) obtains, which is concentrated into medicinal extract density, is slowly added to 95% ethyl alcohol to pure and strong Degree is 70%, is stood overnight, filtrate decompression concentration and recovery to no alcohol taste, continues to be concentrated into the clear cream that relative density is 1.10；
(3) in the medicinal extract for obtaining auxiliary material addition step (2), it is dextrin that the auxiliary material, which is weight proportion: lactose=3:2, is mixed, 10% vinylpyrrolidone K30-95% ethanol solution is added, pelletize, vacuum drying to get.
6. Chinese medicinal granule according to claim 5, which is characterized in that the suppurative dermatosis is acne, impetigo, hair follicle Inflammation, furuncle, carbuncle, erysipelas.
7. a kind of preparation method for the Chinese medicinal granule for treating suppurative dermatosis, which is characterized in that the method is water extract-alcohol precipitation Method；Described method includes following steps:
(1) water mentions twice: the bulk pharmaceutical chemicals of parts by weight: dandelion, Herba Andrographitis, wild chrysanthemum, Fructus Forsythiae, purslane such as weigh, every time plus Water is 8 times of bulk pharmaceutical chemicals total weight, is decocted 2 times, 2 hours every time, collecting decoction, filtration obtained filtrate；
(2) alcohol precipitation: it is 1.2 that the filtrate decompression that step (1) obtains, which is concentrated into medicinal extract density, is slowly added to 95% ethyl alcohol to pure and strong Degree is 70%, is stood overnight, filtrate decompression concentration and recovery to no alcohol taste, continues to be concentrated into the clear cream that relative density is 1.10；
(3) in the medicinal extract for obtaining auxiliary material addition step (2), it is dextrin that the auxiliary material, which is weight proportion: lactose=3:2, is mixed, 10% vinylpyrrolidone K30-95% ethanol solution is added, pelletize, vacuum drying to get.
8. preparation method according to claim 7, which is characterized in that step (3) includes:
A: in the medicinal extract merging granulation pot that step (2) is obtained, dextrin is added, with main stirring 300rpm and cutter 500rpm speed The lower mixing of degree stops stirring to get the first semi-finished product after ten minutes；
B: being added lactose into the first semi-finished product that step a is obtained, to mix under main stirring 300rpm and cutter 500rpm speed It closes and stops stirring to get the second semi-finished product after ten minutes；
C: the second semi-finished product that step b is obtained are added at main stirring 300rpm and cutter 1500rpm velocity conditions PVPK30-95% alcohol slurry, cross the wet whole grain of 14 meshes, through 60 DEG C vacuum drying to get.
9. preparation method according to claim 7, which is characterized in that the method also includes tlc identification methods.
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CN113730485A (en) * 2021-06-11 2021-12-03 张洪琼 Acne-removing traditional Chinese medicine ointment and preparation method thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106063793A (en) * 2015-04-23 2016-11-02 富力 The application in preparation treatment antibacterial infection medicine of phillyrin, its derivant, the phillyrin/phillygenol compositions

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106063793A (en) * 2015-04-23 2016-11-02 富力 The application in preparation treatment antibacterial infection medicine of phillyrin, its derivant, the phillyrin/phillygenol compositions

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
张敏等: "清热解毒颗粒联合米诺环素治疗痤疮的疗效观察", 《中国麻风皮肤病杂志》 *
谢韶琼等: "标本兼顾治疗寻常型痤疮62例临床观察", 《天津中医药》 *
马尔丽等: "高效液相色谱法测定清热解毒冲剂中连翘苷的含量", 《中国药房》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113730485A (en) * 2021-06-11 2021-12-03 张洪琼 Acne-removing traditional Chinese medicine ointment and preparation method thereof

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