CN101601771B - Orally-taken Chinese herb preparation for treating acne and preparation method thereof - Google Patents

Abstract

The invention discloses an orally-taken Chinese herb preparation for treating acne and a preparation method thereof. The preparation is prepared from spreading hedyotis herb, fructus forsythiae, root of red-rooted salvia, scutellaria baicalensis, rhubarb, radix rehmanniae, white mulberry root-bark, tree peony bark, dried tangerine, oyster and radix angelicae. The preparation method of the invention is as follows: spreading hedyotis herb, root of red-rooted salvia and rhubarb are pulverized and are performed with reflux extraction with 90% alcohol; alcohol is recovered until no alcohol flavour exists; fructus forsythiae, tree peony bark, dried tangerine and radix angelicae are pulverized and dipped with water, essential oil is extracted, and oil layers are respectively collected; decoction dregs whose essential oil is extracted, decoction dregs extracted with 90% alcohol and other four medicines are evenly mixed, water is added for decocting, filtering and concentrating, and alcohol is added to ensure that alcohol content is 60%; the mixture stands, liquid supernatant is filtered, and alcohol is recovered until no alcohol flavour exists; concentrated solution is mixed with concentrated solution extracted with 90% alcohol, extracted and dried with reduced pressure; dry extract is pulverized and screened, and essential oil is sprayed in and sealed; magnesium stearate is added, preformed, and coated with film. The orally-taken Chinese herb preparation has the characteristics of simple medicine flavour, reliable curative effect, safety, no toxin, convenient carrying and low cost.

Description

A kind of oral Chinese medicine preparation of treating acne and preparation method thereof

Technical field

The present invention relates to the oral Chinese medicine preparation, be specifically related to a kind of oral Chinese medicine preparation of treating acne and preparation method thereof.

Background technology

Acne (Acne) is the general name of a series of process phenomenons such as acne, comedo, hoary hair, blackhead, reddish tone, pimple, pustule, cyst.Acne is the unitary self limit property disease of a kind of pilosebaceous unit.Research shows, generally occurs in adolescence and follows the damage of various ways, and its pathogenic factors is a lot; It is generally acknowledged it mainly is that the adolescence androgen secretion increases, cause the sebaceous gland enlargement, make hair follicle, sebaceous gland conduit keratinization thromboembolism simultaneously; Sebum deposits and forms fat bolt, i.e. acne in hair follicle.Under oxygen-free environment, a large amount of hypertrophy of anaerobe such as propionibacterium acnes, breeding produce fat dissolving enzyme; Separate sebum and produce free acid, hair follicle stimulating causes inflammation, and the damage of hair follicles wall is broken; The sebum of alluvial gets into intradermal, thereby causes the hair follicle inflammatory reaction of varying degree on every side.In addition, heredity, dyshormonia, greasiness polysaccharide and zest diet, high temperature and some chemical factor also have certain influence to its generation, development.

Though acne is not a kind of serious threat to health, even for the observer, its influence maybe be minimum, owing to be related to skin image (appearance), thus very big to the youngster influence, cause certain psychological burden and stress to the people.Combine pertinent literature that the applicable cases of clinical acne treatment medicine commonly used is in recent years done a general introduction at present.

The Western medicine that is used to treat acne at present comprises oral antibiotic (antibiotics) (minocycline, Roxithromycin and azithromycin), hormonotherapy (oral contraceptive and spironolactone), isotretinoin, other oral drugs (metronidazole, cimetidine, TANSHINONES, Viaminate and oral zinc preparation).Adopt shortcomings such as the existence of chemical medicine treatment acne is cured the symptoms, not the disease, curative effect instability, easy relapse, potential serious adverse reaction.Chinese medical discrimination belongs to exuberant lung-stomach heat and heat in blood folder stasis of blood folder expectorant etc. more, and treatment is with the heat-clearing and toxic substances removing removing heat from blood, and it is principle that spleen invigorating regulating QI to expel dampness, softening the hard mass are opened stasis of blood intestinal stasis relieving.And at present commercially available Chinese patent medicine such as horsepower plinth core are admired, and the Qufeng*** pill that purifies the blood, big Qufeng*** pill etc. all are that a medicine Zhiduo County is sick, the double acne of controlling.And the commercially available active drug of specially controlling acne " bean gram ", " QINGRE ANCHUANG PIAN " has following deficiency again, " 98 yuan of 1 box of bean gram retail price can obey for 1 week, cost an arm and a leg, and curative effect is also unsatisfactory ".

" bean gram " its composition: Flos Lonicerae, Herba Taraxaci, Radix Angelicae Sinensis, Radix Rehmanniae, Cortex Phellodendri, Cornu Bubali, Cornu Saigae Tataricae, Radix Adenophorae (Radix Glehniae), Radix Scutellariae, Radix Paeoniae Rubra, 17 flavors such as Margarita powder.Effect: heat-clearing and toxic substances removing, removing heat from blood is promoted blood circulation.Cure mainly: acne, the double eczema of controlling, dermatitis etc.This side's composition troop is huge, is made up of 17 flavor Chinese medicines, is divided into two big four little six types of medicines in the side:

Antipyretic and antidotal type: Flos Lonicerae, Herba Taraxaci, Cortex Phellodendri, Radix Scutellariae;

Clearing away heat and cooling blood class: Radix Rehmanniae, Cornu Bubali, Radix Paeoniae Rubra;

Suppressing the hyperactive liver to relieve the wind syndrome, removing pathogenic heat from blood and toxic substance from the body class: Cornu Saigae Tataricae;

Tonifying blood and regulating menstruation is invigorated blood circulation: Radix Angelicae Sinensis;

Removing heat from the lung and dissipating phlegm, YIN nourishing and the production of body fluid promoting class: Radix Adenophorae (Radix Glehniae);

Calm the nerves make eye bright, granulation promoting, speckle dispelling class: Margarita powder.

Also have 6 flavor medicines not know which kind of belongs to; Heat-clearing and toxic substances removing and clearing away heat and cooling blood class are when the principal agent and the active drug that are the treatment primary disease; As if other types are little to the acne effect, according to the experience report that motherland's traditional medicine and various places expert treat acne, also seldom treat acne with this type medicine.From effect lack removing dampness, the dampness removing class (is deoiled; Reducing skin oil and fat piles up) and reduce phlegm, the hard masses softening and resolving class, the strength of invigorating blood circulation is also not enough, practical medicine in sick (excretory sebum; Cyst belongs to the insubstantial phlegm of the traditional Chinese medical science; The cicatrix abscess, the tuberosity cyst belongs to phlegm and blood stasis again, the non-blood circulation promoting and blood stasis dispelling eliminating stagnation medicine that reduces phlegm can not be eliminated).

QINGRE ANCHUANG PIAN is made up of 10 multi-flavor medicines such as Flos Lonicerae, Radix Et Rhizoma Rhei, Herba Andrographis, Calculus Bovis, Herba Taraxaci, Margarita powder, Radix Sophorae Tonkinensis, Radix Glycyrrhizae, Fructus Gardeniae, Pulvis Talci, is divided into following several types according to its effect:

Antipyretic and antidotal type: Flos Lonicerae, Radix Et Rhizoma Rhei, Herba Andrographis, Calculus Bovis, Herba Taraxaci, Fructus Gardeniae, Radix Glycyrrhizae, Radix Sophorae Tonkinensis (the eliminating stagnation effect of holding concurrently);

Calm the nerves make eye bright, granulation promoting speckle dispelling class: Margarita powder; What have cool the blood dissipate blood stasis has only Radix Et Rhizoma Rhei simply, and only has the merit of promoting blood circulation to remove blood stasis concurrently; Dampness removing class: Pulvis Talci.Though we's prescription is simplified, prescription in heat-clearing and toxic substances removing, and obviously not enough for the strength of removing heat from blood and promoting blood circulation class, the eliminating stagnation class has only Radix Sophorae Tonkinensis simply, does not more have type of reducing phlegm medicine, and it is unsatisfactory to see its curative effect from its prescription.

Summary of the invention

It is honest and clean to the purpose of this invention is to provide a kind of flavour of a drug letter, and effect is comprehensive, and pathogenesis hits; Especially reuse the Herba Hedyotidis Diffusae endocrine regulation, the balance hormonal readiness is moulded originally and is radically reformed; Treatment must aim at the pathogenesis of disease, and increase the weight of lung heat clearing, the oral Chinese medicine preparation of the treatment acne of relieving constipation removing heat from blood and promoting blood circulation class.

Another object of the present invention provides the method for preparing of this Chinese medicine preparation.

In order to overcome the deficiency of prior art, technical scheme of the present invention is to solve like this: a kind of oral Chinese medicine preparation of treating acne, its special character are by mass ratio by 200g～500g Herba Hedyotidis Diffusae, 150g～300g Fructus Forsythiae; 300g～500g Radix Salviae Miltiorrhizae, 100g～300g Radix Scutellariae, 100g～300g Radix Et Rhizoma Rhei, 200g～500g Radix Rehmanniae; 100g～400g Cortex Mori, 100g～400g Cortex Moutan, 100g～400g Pericarpium Citri Reticulatae; 300g～600g Concha Ostreae, 100g～400g Radix Angelicae Dahuricae is formed, and processes 1000.

Down in the face of the effect of medicine in prescription of respectively distinguishing the flavor of among the present invention, the compatibility relationship of formulation of drug and monarch, minister, help, make and elaborate:

It is monarch drug that this oral Chinese medicine preparation has been selected heavy dose of Herba Hedyotidis Diffusae for use; This medicine not only has heat-clearing and toxic substances removing, inducing diuresis to remove edema, promoting blood circulation and stopping pain effect; The more important thing is that this medical instrument has sex hormone level regulation; Suppress the effect of smegma, reduce, solved the basic reason that acne takes place and reach sebum secretion.Other is equipped with Fructus Forsythiae, Radix Salviae Miltiorrhizae is a minister, and Fructus Forsythiae is persons particularly liable to develop skin infection's a panacea, heat-clearing and toxic substances removing, and blood circulation promoting and dispersing pathogen accumulation, modern pharmacology drug efficacy study show to have antiviral, and be antibiotic, antiendotoxin, antiinflammatory, analgesic, effects such as diuresis; Radix Salviae Miltiorrhizae has stasis-dispelling and pain-killing, removing heat from blood and promoting blood circulation, and the merit of the relieving restlessness that clears away heart-fire, cyst, tuberosity, cicatrix that acne is shown effect repeatedly and formed use like heavy dose that then curative effect is obvious.The modern pharmacology drug efficacy study shows that the effective ingredient that from Radix Salviae Miltiorrhizae, extracts has antiandrogen, antibacterium, antiinflammatory and the effect of regulating immunologic function.Report both scalable endocrine such as Radix Salviae Miltiorrhizae, Herba Hedyotidis Diffusae in addition, can suppress smegma again, can also resist propionibacterium acnes.In this side's the adjuvant drug, Radix Scutellariae, Cortex Mori eliminating the pathogens from the lung heat, the fire of the clear part of the body cavity above the diaphragm housing the heart and lungs; Be the medicine commonly used of acne, Radix Et Rhizoma Rhei is usefulness just right simply, the patients with acne constipation that mostly occurs; Often have several days even person of a week stool, constipation due to heat in the large intestine, pathogenic heat are followed through up and are increased the weight of the state of an illness in face; With taking out firewood at the bottom of the Radix Et Rhizoma Rhei axe, Radix Et Rhizoma Rhei also has the effect of heat clearing and blood circulation promoting blood stasis dispelling in addition.Radix Rehmanniae, Cortex Moutan removing heat from blood and promoting blood circulation are established to excessive heat in the blood system, and Pericarpium Citri Reticulatae, Concha Ostreae are reduced phlegm, and hard masses softening and resolving, modern study show that the content of trace element zinc in the Concha Ostreae is about 45 times of lean meat, and this point is treated acne for this medicine new foundation is provided again in compound recipe.Pericarpium Citri Reticulatae is held concurrently to regulate the flow of vital energy, and makes the capable then blood of gas capable, and the Radix Angelicae Dahuricae is for making, and existing priming is up in face, and the merit of through sick institute also has the wonderful of clean skin appearance.Full side's monarch, compatibility is appropriate, and the medication letter is honest and clean, from the prescription composition analysis, when the effective good recipe that is a subsides treatment acne.

Usage and dosage

Oral, each 4, every day 3 times, minor's decrement.

A kind of method for preparing of treating the oral Chinese medicine preparation of acne, undertaken by following step:

1) takes by weighing Herba Hedyotidis Diffusae, Radix Salviae Miltiorrhizae and Radix Et Rhizoma Rhei by mass ratio, be ground into 3～10 purpose granules, mixing; Use 90% alcohol reflux, wherein 90% amount of ethanol is 8 times of three flavor medical material gross weights, 90% alcohol reflux 3 times; Each 1.0 hours, extracting liquid filtering, filtrating merges; Reclaim ethanol to there not being the alcohol flavor, subsequent use;

2) take by weighing Fructus Forsythiae, Cortex Moutan, Pericarpium Citri Reticulatae and the Radix Angelicae Dahuricae by mass ratio, be ground into 3～10 purpose granules, mixing adds the water of 3～8 times of amounts of four Chinese medicine material gross weight, extracts volatile oil 5 hours with volatile oil extractor, obtains oil reservoir, and is subsequent use;

3) carry medicinal residues and the medicinal residues behind 90% alcohol reflux and Radix Scutellariae, Radix Rehmanniae, Cortex Mori, Concha Ostreae four Chinese medicine material mixing behind the volatile oil; The water that adds above-mentioned medicinal residues and 12 times of amounts of medical material gross weight decocts each 1.0 hours 3 times; Filter, merge filtrating 3 times;

4) concentrating of filtrating, its thickening temperature is 70 ℃～85 ℃, and the relative density measured value is 1.15～1.20 o'clock, slowly adds 95% ethanol again, makes ethanol content reach 60%, stirs, and sealing is left standstill to the supernatant clarification, filters, and filtrate recycling ethanol is to there not being the alcohol flavor;

5) step 4 gained concentrated solution and step 1 gained concentrated solution are merged, using temperature is 70 ℃～85 ℃ concentrating under reduced pressure, uses 60 ℃ of temperature, 0.06Mpa vacuum drying under reduced pressure then; Dry extract was pulverized 40 mesh sieves, sprayed into volatile oil, stirred while spraying; Mixing; Put and seal 24 hours in the hermetic container, take out, dry;

6) with 80 be sieved into dry extract amount 1% magnesium stearate, mixed 30 minutes, with the shallow round stamping of Φ 11.5mm, the heavy 0.5g of sheet, film coating, bottling.

The oral Chinese medicine preparation formulation of said preparation comprises tablet, capsule, soft capsule, granule, oral liquid, syrup, powder.

The specific embodiment

Below in conjunction with embodiment summary of the invention is described further:

Embodiment 1

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by 200g～500g Herba Hedyotidis Diffusae, 150g～300g Fructus Forsythiae, 300g～500g Radix Salviae Miltiorrhizae; 100g～300g Radix Scutellariae, 100g～300g Radix Et Rhizoma Rhei, 200g～500g Radix Rehmanniae; 100g～400g Cortex Mori, 100g～400g Cortex Moutan, 100g～400g Pericarpium Citri Reticulatae; 300g～600g Concha Ostreae, 100g～400g Radix Angelicae Dahuricae is formed, and processes 1000.

The method for preparing of the oral Chinese medicine preparation of treatment acne, undertaken by following step:

1) takes by weighing Herba Hedyotidis Diffusae, Radix Salviae Miltiorrhizae and Radix Et Rhizoma Rhei by mass ratio, be ground into 3～10 purpose granules, mixing; Use 90% alcohol reflux, wherein 90% amount of ethanol is 8 times of three flavor medical material gross weights, 90% alcohol reflux 3 times; Each 1.0 hours, extracting liquid filtering, filtrating merges.Reclaim ethanol to there not being the alcohol flavor, subsequent use;

2) take by weighing Fructus Forsythiae, Cortex Moutan, Pericarpium Citri Reticulatae and the Radix Angelicae Dahuricae by mass ratio, be ground into 3～10 purpose granules, mixing adds the water of 3～8 times of amounts of four Chinese medicine material gross weight, extracts volatile oil 5 hours with volatile oil extractor, obtains oil reservoir, and is subsequent use;

3) carry medicinal residues and the medicinal residues behind 90% alcohol reflux and Radix Scutellariae, Radix Rehmanniae, Cortex Mori, Concha Ostreae four Chinese medicine material mixing behind the volatile oil; The water that adds above-mentioned medicinal residues and 12 times of amounts of medical material gross weight decocts each 1.0 hours 3 times; Filter, merge filtrating 3 times;

4) concentrating of filtrating, its thickening temperature is 70 ℃～85 ℃, and the relative density measured value is 1.15～1.20 o'clock, slowly adds 95% ethanol again, makes ethanol content reach 60%, stirs, and sealing is left standstill to the supernatant clarification, filters, and filtrate recycling ethanol is to there not being the alcohol flavor;

5) step 4 gained concentrated solution and step 1 gained concentrated solution are merged, using temperature is 70 ℃～85 ℃ concentrating under reduced pressure, uses 60 ℃ of temperature, 0.06Mpa vacuum drying under reduced pressure then; Dry extract was pulverized 40 mesh sieves, sprayed into volatile oil, stirred while spraying; Mixing; Put and seal 24 hours in the hermetic container, take out, dry;

6) with 80 be sieved into dry extract amount 1% magnesium stearate, mixed 30 minutes, with the shallow round stamping of Φ 11.5mm, the heavy 0.5g of sheet, film coating, bottling.

Embodiment 2

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by 210g～480g Herba Hedyotidis Diffusae, 160g～280g Fructus Forsythiae, 320g～480g Radix Salviae Miltiorrhizae; 120g～280g Radix Scutellariae, 110g～280g Radix Et Rhizoma Rhei, 220g～480g Radix Rehmanniae; 110g～380g Cortex Mori, 110g～380g Cortex Moutan, 110g～380g Pericarpium Citri Reticulatae; 320g～580g Concha Ostreae, 110g～380g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 3

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by 230g～450g Herba Hedyotidis Diffusae, 180g～260g Fructus Forsythiae, 350g～450g Radix Salviae Miltiorrhizae; 140g～260g Radix Scutellariae, 130g～260g Radix Et Rhizoma Rhei, 240g～460g Radix Rehmanniae; 140g～360g Cortex Mori, 130g～360g Cortex Moutan, 140g～360g Pericarpium Citri Reticulatae; 340g～560g Concha Ostreae, 130g～360g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 4

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by 260g～400g Herba Hedyotidis Diffusae, 200g～240g Fructus Forsythiae, 380g～420g Radix Salviae Miltiorrhizae; 180g～240g Radix Scutellariae, 180g～240g Radix Et Rhizoma Rhei, 280g～400g Radix Rehmanniae; 180g～300g Cortex Mori, 160g～300g Cortex Moutan, 180g～300g Pericarpium Citri Reticulatae; 380g～500g Concha Ostreae, 200g～300g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 5

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by 280g～350g Herba Hedyotidis Diffusae, 210g～230g Fructus Forsythiae, 390g～410g Radix Salviae Miltiorrhizae; 190g～220g Radix Scutellariae, 190g～220g Radix Et Rhizoma Rhei, 300g～350g Radix Rehmanniae; 200g～270g Cortex Mori, 180g～260g Cortex Moutan, 200g～250g Pericarpium Citri Reticulatae; 400g～450g Concha Ostreae, 220g～280g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 6

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by the 200g Herba Hedyotidis Diffusae, 300g Fructus Forsythiae, 500g Radix Salviae Miltiorrhizae, 300g Radix Scutellariae; The 300g Radix Et Rhizoma Rhei, 200g Radix Rehmanniae, 400g Cortex Mori, 400g Cortex Moutan; The 400g Pericarpium Citri Reticulatae, the 600g Concha Ostreae, the 400g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 7

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by the 500g Herba Hedyotidis Diffusae, 150g Fructus Forsythiae, 300g Radix Salviae Miltiorrhizae, 100g Radix Scutellariae; The 100g Radix Et Rhizoma Rhei, 200g Radix Rehmanniae, 100g Cortex Mori, 100g Cortex Moutan; The 100g Pericarpium Citri Reticulatae, the 300g Concha Ostreae, the 100g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 8

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by the 300g Herba Hedyotidis Diffusae, 200g Fructus Forsythiae, 400g Radix Salviae Miltiorrhizae, 200g Radix Scutellariae; The 200g Radix Et Rhizoma Rhei, 300g Radix Rehmanniae, 200g Cortex Mori, 300g Cortex Moutan; The 300g Pericarpium Citri Reticulatae, the 400g Concha Ostreae, the 300g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 9

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by the 480g Herba Hedyotidis Diffusae, 160g Fructus Forsythiae, 320g Radix Salviae Miltiorrhizae, 120g Radix Scutellariae; The 110g Radix Et Rhizoma Rhei, 220g Radix Rehmanniae, 110g Cortex Mori, 110g Cortex Moutan; The 110g Pericarpium Citri Reticulatae, the 320g Concha Ostreae, the 110g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 10

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by the 210g Herba Hedyotidis Diffusae, 280g Fructus Forsythiae, 480g Radix Salviae Miltiorrhizae, 280g Radix Scutellariae; The 280g Radix Et Rhizoma Rhei, 480g Radix Rehmanniae, 380g Cortex Mori, 380g Cortex Moutan; The 380g Pericarpium Citri Reticulatae, the 580g Concha Ostreae, the 380g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 11

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by the 350g Herba Hedyotidis Diffusae, 250g Fructus Forsythiae, 400g Radix Salviae Miltiorrhizae, 250g Radix Scutellariae; The 250g Radix Et Rhizoma Rhei, 300g Radix Rehmanniae, 300g Cortex Mori, 350g Cortex Moutan; The 320g Pericarpium Citri Reticulatae, the 400g Concha Ostreae, the 320g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 12

The oral Chinese medicine preparation of treatment acne is characterized in that by mass ratio by the 400g Herba Hedyotidis Diffusae 200g Fructus Forsythiae, 380g Radix Salviae Miltiorrhizae, 180g Radix Scutellariae; The 180g Radix Et Rhizoma Rhei, 280g Radix Rehmanniae, 180g Cortex Mori, 160g Cortex Moutan; The 180g Pericarpium Citri Reticulatae, the 380g Concha Ostreae, the 200g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 13

The oral Chinese medicine preparation of treatment acne is characterized in that by mass ratio by the 260g Herba Hedyotidis Diffusae 240g Fructus Forsythiae, 420g Radix Salviae Miltiorrhizae, 240g Radix Scutellariae; The 240g Radix Et Rhizoma Rhei, 400g Radix Rehmanniae, 300g Cortex Mori, 300g Cortex Moutan; The 300g Pericarpium Citri Reticulatae, the 500g Concha Ostreae, the 300g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

Embodiment 14

The oral Chinese medicine preparation of treatment acne is pressed mass ratio by the 300g Herba Hedyotidis Diffusae, 220g Fructus Forsythiae, 400g Radix Salviae Miltiorrhizae, 200g Radix Scutellariae; The 200g Radix Et Rhizoma Rhei, 330g Radix Rehmanniae, 250g Cortex Mori, 230g Cortex Moutan; The 220g Pericarpium Citri Reticulatae, the 420g Concha Ostreae, the 260g Radix Angelicae Dahuricae is formed, and processes 1000.The method for preparing of Chinese medicine preparation is with embodiment 1.

In sum, function of the present invention is heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating, purging FU-organs intestinal stasis relieving.

Cure mainly: acne vulgaris belongs to accumulated heat in the lung and stomach card person, and disease is seen acne, pimple, and pustule, erythra is itched bitterly, face red complexion, thirst and liking drink, yellowish urine, constipation, red tongue, yellow fur, rapid pulse.

Be elaborated in the face of clinical efficacy of the present invention, cure rate, toxicity test down:

1, clinical case number (＞100 example)

According to the related content introduction of acne 116 examples, take " acne spirit ", every day 2 times, each 5 grams, taking medicine after meal sooner or later.Use 2 and avoid sweet food, rich food and pungent stimulus object more than the course of treatment simultaneously, through statistics 116 routine patients, the result cures 63 examples in the recent period, produce effects 24 examples, and effective 19 examples, invalid 10 examples, total effective rate is 91.3%, does not find obvious toxic-side effects and untoward reaction.

2, curative effect determinate standard

(1) acne curative effect determinate standard

(formulating) with reference to " the clinical research guideline of new Chinese medicine treatment acne vulgaris " in Chinese Medicine science and technology publishing house's in May, 2002 front page " new Chinese medicine clinical research guideline "

A. clinical recovery: skin lesion extinction rate >=95%.

B. produce effects: 95%＞skin lesion extinction rate >=70%.

C. effective: 70%＞skin lesion extinction rate >=50%.

D. invalid: skin lesion extinction rate＜50%, or counter see increase.

(2) accumulated heat in the lung and stomach card curative effect determinate standard

(formulating) with reference to " the clinical research guideline of new Chinese medicine treatment acne vulgaris " in Chinese Medicine science and technology publishing house's in May, 2002 front page " new Chinese medicine clinical research guideline "

A. clinical recovery: tcm clinical practice symptom, sign disappear or basic the disappearance, and the syndrome integration reduces >=95%.

B. produce effects: tcm clinical practice symptom, sign are obviously improved, and the syndrome integration reduces >=70%.

C. effective: tcm clinical practice symptom, sign all take a favorable turn, and the syndrome integration reduces >=50%.

D. invalid: tcm clinical practice symptom, sign all do not have obvious improvement, even increase the weight of, the syndrome integration reduces less than 50%.

3, pharmacodynamics test report; Animal experiment report (toxicity test, the long poison of anxious poison).

(1) pharmacodynamic experiment

The present invention causes rat auricle acne to propionibacterium acne has obvious minimizing effect; The stratified squamous epithelium that all occurs skin surface in model group 10 examples thickens; Skin corium forms a plurality of abscess, and the fibrous connective tissue hypertrophy around the abscess has a large amount of cell infiltration; With neutrophil is main, the abscess peripheral vasodilation.The stratified squamous epithelium that 14.364g crude drug/kg of the present invention, 7.182g crude drug/kg and 3.591g crude drug/kg have 3 examples, 4 examples and 10 examples skin surface to occur respectively thickens, and skin corium forms abscess, abscess peripheral vasodilation.The in-vitro antibacterial test shows; The Bai Liandan sheet has obvious suppression and killing action to staphylococcus aureus, staphylococcus epidermidis, propionibacterium acne; Its MIC and MBC are respectively 0.977mg/ml and 7.81mg/ml, 0.977mg/ml and 3.91mg/ml and 62.5mg/ml and 125mg/ml.Beta hemolytic streptococcus and Pseudomonas aeruginosa there are stronger inhibition and killing action; Its MIC and MBC are respectively 62.5mg/ml and 250mg/ml; 62.5mg/ml and 250mg/ml, ETEC and streptococcus pneumoniae are also had certain inhibition and killing action.The mouse skin inflammation that 19.12g crude drug/kg of the present invention brings out gonadal hormone has and significantly alleviates effect; 19.12g crude drug/kg of the present invention obviously reduces the mouse peritoneal capillary permeability; 19.12g crude drug/kg of the present invention, 9.56g crude drug/kg xylol induced mice auricle edema have and obviously alleviate effect; Rat paw edema 1h, 2h, 3h, 4h, 5h, 6h after causing inflammation all show and significantly alleviate effect due to 14.364g crude drug of the present invention/kg on Carrageenan; Bai Liandan sheet 14.364g crude drug/kg is formed with remarkable inhibitory action to rat plastic hoop granulation tissue.

(2) toxicological experiment

1. acute toxicity test

The present invention does not measure LD for ICR strain mouse stomach ₅₀, it receives reagent thing amount most greatly is 30g/kgbw, is equivalent to former 149.625 crude drug g/kgbw, is about clinical people and intends 312.5 times of consumption.So it is 30g/kgbw that this test provides chmice acute toxicity safety using amount.

2. long term toxicity test

Press 34.4736g crude drug/kgbw, 17.2368g crude drug/kgbw and 8.6184g crude drug/kgbw, three dosage are given rat oral gavage three months, are equivalent to clinical people respectively and intend 72,36 and 18 times of consumption.Weigh weekly once, survey forage volume, amount of drinking water once, administration is 7 days weekly.Last giving received behind the reagent thing 24 hours, and every group of works is 10 rats extremely, male and female half and half; Carry out coherence check; As a result rat generally in order, heavy dose of group male rat weight increase, but since the 5th week weight increase be starkly lower than matched group (P＜0.01); Heavy dose of group female rats and middle small dose group rat body weight increase with matched group does not relatively have significant difference, diet, hair color, movable normal.After the administration three months, get 10 for every group, female, hero half and half; Electrocardiogram, routine urinalysis detect normal, and common carotid artery is got blood, carries out hematological examination and blood biochemistry checking; Result and matched group relatively do not have significant difference, separate and get each organs and tissues, and organ index and matched group relatively do not have significant difference; Histopathologic examination shows that each organs and tissues does not also have pathology and changes.Live again after 2 weeks of drug withdrawal and remain rat extremely, every group of 10 rats, female, hero half and half, the observation project is the same, and each test item is all normal, clinical safety consumption 34.4736g is provided crude drug/kgbw for this reason, 72 times of intending consumption for clinical people.

Observe and test through lots of clinical, find that it is characteristic that acne locates to take place infringements such as pimple, acne, abscess, tuberosity with head, face, breast, the back of the body etc.Its morbidity is relevant with " heat ", lung-heat, heat in blood, damp and hot be primary disease main diseases because of, secondly stagnation of QI, blood stasis, expectorant knot also can cause morbidity.Treatment is main with clearing away heat and cooling blood, takes into account the rule of invigorating spleen to remove dampness, blood circulation promoting and blood stasis dispelling simultaneously.The old rule that this is consistent has for many years not only been brought confidence to us in clinical practice, but in trial test, has also obtained people's good efficacy.

The present invention is theoretical about the etiology and pathogenesis theory of acne (rosacea caused by lung-wind) and traditional medication according to traditional Chinese medical science successive dynasties ancient books and records, and the multinomial achievement that combines for many years clinical practice experience and Chinese medicine modern times clinical pharmacology to study is carried out.We adhere to the medication of instruction of Chinese Medicine theory prescription, as the sole criterion of judging that medication is whether appropriate, so just make that the specific aim of prescription medication is stronger to curative effect, and almost every flavor medicine all is to characterize with a definite target in view to each of primary disease.Therefore, obtained good curative effect.

So it selects oral this tradition and easy dosage form, then be the inspiration that receives classic doctor's nationality fully." Waike Zhengzong, Orthodox Manual of External Diseases " of Ming Dynasty's Chen Shigong say " rosacea caused by lung-wind, always all heat in blood stasis is not loose, what is called have all in, outside shape is all." find expression in the acne skin lesion at head, face, breast, back, be the result that body internal environment imbalance changes.Therefore, oral administration is to tackle the problem at its root, so much better certainly than external treatment.Imitate in for the moment because external treatment can only be got, and the internal treatment not only good effect and effect are lasting.Below we divide several aspects to have a talk selected topic foundation.

Analysis about the etiology and pathogenesis of acne:

The cause of disease of acne is more, and mechanism is also very complicated.Conclude main and androgen, sebum secretion increases, the hyperkeratosis of pilosebaceous unit pipe, and propionibacterium acnes moves and gives birth to and inflammation-related in the glandular tube.

1. androgen: its stimulates sebaceous hyperplasia and sebum secretion, and influences pilosebaceous unit glandular tube keratinization.Phase adrenal gland function is active therewith in hebetic disease occurred frequently for acne, and the androgen secretion increasing is relevant.The serum androgen level affects the morbidity of acne, but and not exclusive factor.Isolate sex hormone receptor from normal human skin, thereby confirm that skin and adnexa thereof are one of target organs of gonadal hormone.The activity that is combining to regulate and control sebaceous gland of androgen and corresponding receptor.

2. the adjusting of sebum secretion: sebum secretion increases relevant with the acne order of severity.The secretion of sebaceous gland is different and variant with sex because of the age.Male's sebum secretion is higher than the women.Therefore, the incidence rate of women's acne is few than the male relatively, but the adolescence exception.

3. lipid components is unusual: the primary product of smegma is free fatty, oxidation zamene, these lipids of linoleic acid, and the lipid of skin surface is mainly derived from epidermis and sebaceous gland, and the diacrisis of these lipids can cause the formation of acne.Particularly the linoleic acid shortage estimates at important function in acne form.

4. follicular keratosis: follicular keratosis, epithelial cell can not normally come off, and follicular orifice diminishes, and sebum deposits in follicular orifice, forms acne.Keratinocyte in the follicular canal can be similar with the surface horny cell to the reaction of hydration in addition, and the excessive hydration of skin (as perspiring) causes that easily sebaceous gland duct blocks, and hinders sebum secretion and drains, and is found in the situation that many excessive hydrations increase the weight of acne clinically.

5. microorganism: antibacterial is the key link that produces the acne inflammation.The skin region that is prone to the trouble acne often has three kinds of bacterial colonizations: propionibacterium acnes, staphylococcus epidermidis, bran Pi pityrosporion ovale.Majority can obviously reduce acne to the effective antimicrobial therapy of acne.

6. inflammatory mediator and inflammation: the material in the acne " spills " through follicular wall and starts inflammation.This inflammation is a dynamic process, and most of struvite skin lesion are relevant with the expansion of infundibulum of hair follicle.Inflammatory reaction is comprising immunity and two aspects of non-immunity.Acne is a kind of rejection of patient to the intradermal foreign body.Acne patient has the antibody response to propionibacterium acnes, and the order of severity of acne is consistent with the TH cytoactive.The detection of many immunologic functions has found that the morbidity of acne is relevant with the immunity of human body, mainly shows as humoral immunization and has participated in the pathological process that the acne inflammation produces.

7. in addition, somebody's research thinks that the generation of acne is relevant, relevant with microcirculation disturbance, numerous with the interior trace element zinc deficiency of body.

The present invention compared with prior art has flavour of a drug and simplifies, and curative effect is reliable, and safety non-toxic is easy to carry; Cost is low, and the pathogenesis that hits is especially reused the Herba Hedyotidis Diffusae endocrine regulation, and the balance hormonal readiness is moulded originally and radically reformed; Treatment must aim at the pathogenesis of disease, and increase the weight of lung heat clearing, relieving constipation removing heat from blood and promoting blood circulation class makes effect heighten." letter, just, honest and clean, test " four characteristics, its side's medicine composition analysis has following advantage:

1, the growth of sebaceous gland is arranged by androgen, and the androgenic generation increase of adolescence increases sebaceous gland, and sebum secretion increases; Sebum is excreted to skin surface through follicular orifice; And the follicular epithelium dyskeratosis of patients with acne can not normally come off, and follicular orifice is diminished; The sebum alluvial forms acne (this will open stasis of blood intestinal stasis relieving in treatment) at follicular orifice, so reduce the key point that sebum secretion is the solution patient through reducing androgenic ratio.

2, to have selected heavy dose of Herba Hedyotidis Diffusae for use be monarch drug in the present invention, and according to the document announcement in nearly ten years, this medicine not only had heat-clearing and toxic substances removing; Inducing diuresis to remove edema; The promoting blood circulation and stopping pain effect the more important thing is that this medical instrument has sex hormone level regulation, suppresses the effect of smegma; Reduce and reach sebum secretion, solved the basic reason that acne takes place.Other is equipped with Fructus Forsythiae, Radix Salviae Miltiorrhizae is a minister, and Fructus Forsythiae is persons particularly liable to develop skin infection's a panacea, heat-clearing and toxic substances removing, and blood circulation promoting and dispersing pathogen accumulation, modern pharmacology drug efficacy study show to have antiviral, and be antibiotic, antiendotoxin, antiinflammatory, analgesic, effects such as diuresis; Radix Salviae Miltiorrhizae has stasis-dispelling and pain-killing, removing heat from blood and promoting blood circulation, and the merit of the relieving restlessness that clears away heart-fire, to the cyst that acne is shown effect repeatedly and formed, tuberosity, cicatrix uses like heavy dose that then curative effect is obvious.The modern pharmacology drug efficacy study shows that the effective ingredient that from Radix Salviae Miltiorrhizae, extracts has antiandrogen, antibacterium, antiinflammatory and the effect of regulating immunologic function.Report both scalable endocrine such as Radix Salviae Miltiorrhizae, Herba Hedyotidis Diffusae in addition, can suppress smegma again, can also resist propionibacterium acnes.In this side's the adjuvant drug, Radix Scutellariae, Cortex Mori eliminating the pathogens from the lung heat; The fire of the clear part of the body cavity above the diaphragm housing the heart and lungs is the medicine commonly used of acne, and Radix Et Rhizoma Rhei is usefulness just right simply; The patients with acne constipation that mostly occurs often has several days even person of a week stool, constipation due to heat in the large intestine; Pathogenic heat is followed through up and is increased the weight of the state of an illness in face, and with taking out firewood at the bottom of the Radix Et Rhizoma Rhei axe, Radix Et Rhizoma Rhei also has the effect of heat clearing and blood circulation promoting blood stasis dispelling in addition.The Radix Rehmanniae, the Cortex Moutan removing heat from blood and promoting blood circulation is established to excessive heat in the blood system, Pericarpium Citri Reticulatae, Concha Ostreae is reduced phlegm, and hard masses softening and resolving, modern study show that the content of trace element zinc in the Concha Ostreae is about 45 times of lean meat, and this point is treated acne for this medicine new foundation is provided again in compound recipe.Pericarpium Citri Reticulatae is held concurrently to regulate the flow of vital energy, and makes the capable then blood of gas capable, and the Radix Angelicae Dahuricae is for making, and existing priming is up in face, and the merit of through sick institute also has the wonderful of clean skin appearance.Full side's monarch, compatibility is appropriate, and the medication letter is honest and clean.

Claims (6)

1. oral Chinese medicine preparation of treating acne is characterized in that by mass ratio by 200g～500g Herba Hedyotidis Diffusae 150g～300g Fructus Forsythiae, 300g～500g Radix Salviae Miltiorrhizae; 100g～300g Radix Scutellariae, 100g～300g Radix Et Rhizoma Rhei, 200g～500g Radix Rehmanniae; 100g～400g Cortex Mori, 100g～400g Cortex Moutan, 100g～400g Pericarpium Citri Reticulatae; 300g～600g Concha Ostreae, 100g～400g Radix Angelicae Dahuricae is formed, and processes 1000.

2. the oral Chinese medicine preparation of treatment acne according to claim 1 is characterized in that by mass ratio by 210g～480g Herba Hedyotidis Diffusae 160g～280g Fructus Forsythiae, 320g～480g Radix Salviae Miltiorrhizae; 120g～280g Radix Scutellariae, 110g～280g Radix Et Rhizoma Rhei, 220g～480g Radix Rehmanniae; 110g～380g Cortex Mori, 110g～380g Cortex Moutan, 110g～380g Pericarpium Citri Reticulatae; 320g～580g Concha Ostreae, 110g～380g Radix Angelicae Dahuricae is formed, and processes 1000.

3. the oral Chinese medicine preparation of treatment acne according to claim 1 and 2 is characterized in that by mass ratio by 230g～450g Herba Hedyotidis Diffusae 180g～260g Fructus Forsythiae, 350g～450g Radix Salviae Miltiorrhizae; 140g～260g Radix Scutellariae, 130g～260g Radix Et Rhizoma Rhei, 240g～460g Radix Rehmanniae; 140g～360g Cortex Mori, 130g～360g Cortex Moutan, 140g～360g Pericarpium Citri Reticulatae; 340g～560g Concha Ostreae, 130g～360g Radix Angelicae Dahuricae is formed, and processes 1000.

4. the oral Chinese medicine preparation of treatment acne according to claim 3 is characterized in that by mass ratio by 260g～400g Herba Hedyotidis Diffusae 200g～240g Fructus Forsythiae, 380g～420g Radix Salviae Miltiorrhizae; 180g～240g Radix Scutellariae, 180g～240g Radix Et Rhizoma Rhei, 280g～400g Radix Rehmanniae; 180g～300g Cortex Mori, 160g～300g Cortex Moutan, 180g～300g Pericarpium Citri Reticulatae; 380g～500g Concha Ostreae, 200g～300g Radix Angelicae Dahuricae is formed, and processes 1000.

5. the oral Chinese medicine preparation of treatment acne according to claim 4 is characterized in that by mass ratio by 280g～350g Herba Hedyotidis Diffusae 210g～230g Fructus Forsythiae, 390g～410g Radix Salviae Miltiorrhizae; 190g～220g Radix Scutellariae, 190g～220g Radix Et Rhizoma Rhei, 300g～350g Radix Rehmanniae; 200g～270g Cortex Mori, 180g～260g Cortex Moutan, 200g～250g Pericarpium Citri Reticulatae; 400g～450g Concha Ostreae, 220g～280g Radix Angelicae Dahuricae is formed, and processes 1000.

6. the method for preparing of the oral Chinese medicine preparation of the described treatment acne of claim 1, undertaken by following step:

1) takes by weighing Herba Hedyotidis Diffusae, Radix Salviae Miltiorrhizae and Radix Et Rhizoma Rhei by mass ratio, be ground into 3～10 purpose granules, mixing; Use 90% alcohol reflux, wherein 90% amount of ethanol is 8 times of three flavor medical material gross weights, 90% alcohol reflux 3 times; Each 1.0 hours, extracting liquid filtering, filtrating merges; Reclaim ethanol to there not being the alcohol flavor, subsequent use;

2) take by weighing Fructus Forsythiae, Cortex Moutan, Pericarpium Citri Reticulatae and the Radix Angelicae Dahuricae by mass ratio, be ground into 3～10 purpose granules, mixing adds the water of 3～8 times of amounts of four Chinese medicine material gross weight, extracts volatile oil 5 hours with volatile oil extractor, obtains oil reservoir, and is subsequent use;

3) carry medicinal residues and the medicinal residues behind 90% alcohol reflux and Radix Scutellariae, Radix Rehmanniae, Cortex Mori, Concha Ostreae four Chinese medicine material mixing behind the volatile oil; The water that adds above-mentioned medicinal residues and 12 times of amounts of medical material gross weight decocts each 1.0 hours 3 times; Filter, merge filtrating 3 times;

4) concentrating of filtrating, its thickening temperature is 70 ℃～85 ℃, and the relative density measured value is 1.15～1.20 o'clock, slowly adds 95% ethanol again, makes ethanol content reach 60%, stirs, and sealing is left standstill to the supernatant clarification, filters, and filtrate recycling ethanol is to there not being the alcohol flavor;

5) step 4 gained concentrated solution, the subsequent use material of step 1 gained are merged, using temperature is 70 ℃～85 ℃ concentrating under reduced pressure, uses 60 ℃ of temperature, 0.06Mpa vacuum drying under reduced pressure then; Dry extract was pulverized 40 mesh sieves, sprayed into volatile oil, stirred while spraying; Mixing; Put and seal 24 hours in the hermetic container, take out, dry;

6) with 80 be sieved into dry extract amount 1% magnesium stearate, mixed 30 minutes, with the shallow round stamping of Φ 11.5mm, the heavy 0.5g of sheet, film coating, bottling.