CN101380406B - Medicine for treating cheilitis and preparation method thereof - Google Patents
Medicine for treating cheilitis and preparation method thereof Download PDFInfo
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- CN101380406B CN101380406B CN2008102318583A CN200810231858A CN101380406B CN 101380406 B CN101380406 B CN 101380406B CN 2008102318583 A CN2008102318583 A CN 2008102318583A CN 200810231858 A CN200810231858 A CN 200810231858A CN 101380406 B CN101380406 B CN 101380406B
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Abstract
The invention discloses a medicine for treating chronic cheilitis and a preparation method thereof. The medicine comprises the following drug ingredients by weight percentage: 11-13% of root of rehmannia, 7-9% of parsnip, 7-9% of angelica, 7-9% of herba schizonepetae, 7-9% of salvia miltiorrhiza, 7-9% of radix scrophulariae, 7-9% of nutgrass galingale rhizome, 7%-9% of glossy ganoderma, 23%-25% of herba houttuyniae, 7%-9% of angelica dahurica. The sum of the percentage of the traditional Chinese drug ingredients is 100%. The preparation method includes that volatile oil is extracted from the herba schizonepetae; the salvia miltiorrhiza and the nutgrass galingale rhizome are extracted for twice with ethanol and are filtered; the thick paste of the ethanol is recycled; dregs of a decoction and the remained drug ingredients are together decocted in water and extracted for three times, and filtered; the filtrate and the volatile oil water are together concentrated into the thick paste, and the two thick pastes are combined, added with dextrine and white sugar, prepared into particles, dried, finished, and then added with the volatile oil, finally are sub packed. The acute toxicity test of animals and the main pharmacology test prove that the medicine has reasonable formulation, convenient taking, prominent drug action, and safe use and is the novel medicine for treating the diseases of yin deficiency, insomnia, urticaria, and exfoliative inflammation of lip, anemia, etc.
Description
Technical field
The present invention relates to a kind of medicine and preparation thereof, particularly a kind of medicine that is used for the treatment of the chronic cheilitis disease and preparation method thereof.
Background technology
Cheilitis, the traditional Chinese medical science is called the exfoliative inflammation of the lips, serve as mainly to show with lip redness, desquamation, sufferings, the stream yellow liquid that with the passing of time ftractures, festers how.In recent years, along with increasing of lip cosmetic, the appearance of medicine toothpaste, and the influence of bad life habits such as surfeit is pungent, irritable food, make the cheilitis patient that the trend that day by day increases be arranged, not only directly influence feed and communication, it is attractive in appearance more to impair image, and people's mood of seeking medical advice is very urgent.Treatment to chronic cheilitis is at present more thorny, and microwave radiation is a kind of electromagnetic radiation, and organism is by containing a large amount of charged ions and polarity non-polar molecule in the inside and outside liquid of various cells, vibration and rotation taking place under the effect of microwave electric field.Microwave has stronger penetrance and diathermanous principle, thereby makes increase in temperature in the tissue, and accelerate blood circulation and lymphatic return improve immunologic function, and tangible blood circulation promoting and blood stasis dispelling is arranged, effects such as convergence pain relieving.Vitamin E has been widely used in clinical simultaneously, many scholars think that it can prevent and suppress the epithelial cell keratinization, promote cellular metabolism, make multiple unsaturated fatty acid avoid oxidation, keep the stable of cell membrane and organelle, and then promote that skin histology immediate union, a mouthful safe collutory are to be synthesized by medicines such as hibitane, metronidazoles to have stronger antibacterial and anti-inflammation functions.It is unsatisfactory to use curative effect according to relevant report corticosteroid whole body, and side effect is big, and Western medicine does not still have the specially good effect means in the treatment of this disease.Though there has been said method treatment chronic cheilitis in market, all belongs to topical therapeutic and has the shortcoming of easy recurrence.
Summary of the invention
The objective of the invention is to be, a kind of medicine that is used for the treatment of the chronic cheilitis disease and preparation method thereof is provided, the pure Chinese medicine medicine that this choice of drug is cheap, can be at stomach through damp and hot, diseases caused by exogenous pathogenic factor ailment said due to cold or exposure, wind heat is fought mutually, and with the passing of time disease symptomatic treatments such as wind-induced deficiency of YIN insomnia, urticaria, the exfoliative inflammation of the lips, anemia are given birth in dryness-transformation.
In order to realize above-mentioned task, the present invention adopts following technical solution:
A kind of medicine that is used for the treatment of the chronic cheilitis disease is characterized in that, this medicine that makes is made up of the effective ingredient and the percentage by weight thereof of following medical material: the Radix Rehmanniae: 11%～13%, Radix Saposhnikoviae: 7%～9%, Radix Angelicae Sinensis: 7%～9%, Herba Schizonepetae: 7%～9%, Radix Salviae Miltiorrhizae: 7%～9%, Radix Scrophulariae: 7%～9%, Rhizoma Cyperi: 7%～9%, Oletum Trogopterori: 7%～9%, Herba Houttuyniae: 23%～25%, the Radix Angelicae Dahuricae: 7%～9%, the percentage ratio sum of above-mentioned medical material is 100%.
The above-mentioned medicine that is used for the treatment of the chronic cheilitis disease, form by following Chinese medicine medical material effective ingredient and percentage by weight thereof: the Radix Rehmanniae: 12%, Radix Saposhnikoviae: 8%, Radix Angelicae Sinensis: 8%, Herba Schizonepetae: 8%, Radix Salviae Miltiorrhizae: 8%, Radix Scrophulariae: 8%, Rhizoma Cyperi: 8%, Oletum Trogopterori: 8%, Herba Houttuyniae: 24%, the Radix Angelicae Dahuricae: 8%, the percentage ratio sum of above-mentioned Chinese medicine medical material is 100%.
The above-mentioned preparation method that is used for the treatment of the medicine of chronic cheilitis disease is characterized in that, comprises sequence step:
Step 1 is extracted volatile oil with the Herba Schizonepetae in the prescription, and the Herba Schizonepetae water extract behind the extraction volatile oil is standby;
Step 2 is 85% ethanol extraction 2 times with Radix Salviae Miltiorrhizae, Rhizoma Cyperi in the prescription with mass fraction, extracts 2 hours at every turn, its alcoholic acid addition is Radix Salviae Miltiorrhizae and Rhizoma Cyperi 4.5 times, merges ethanol extract, filters, reclaim ethanol, it is standby to get the ethanol thick paste after alcohol extract concentrates;
Step 3, other medical material in medicinal residues behind Radix Salviae Miltiorrhizae and the Rhizoma Cyperi ethanol extraction and the prescription is decocted with water 3 times, and each 1 hour, amount of water was 12 times of other medical material weight in medicinal residues and the prescription, collecting decoction, filter, add Herba Schizonepetae water extract, filtrate concentrates, add the ethanol thick paste again, under 50 ℃ of conditions, be concentrated into relative density and be 1.25～1.30 thick paste, and make the thick paste powder;
Step 4, other gets dextrin and cane sugar powder, and by the thick paste powder: sucrose: dextrin=1:2.5:1 feeds intake, and adds an amount of ethanol and makes soft material, and is dry under 65 ℃ of conditions after granulating, and crosses 10 mesh sieves then, granulate, adds volatile oil, and airtight, patent medicine is made in packing.
The medicine that is used for the treatment of the chronic cheilitis disease of the present invention's preparation, its prescription selects medicine correct, and compatibility is reasonable, and the monarch primary and secondary is suitable, has the yin nourishing of dispeling the wind, the effect of blood circulation promoting and blood stasis dispelling.Deficiency of YIN insomnia, urticaria, the exfoliative inflammation of the lips, anemia etc. are all had better curative effect, and oral systemic administration, cycle are short, easy, the safety of its preparation method, low production cost, curative effect is outstanding, has remedied the topical therapeutic of Western medicine on the market and repeatedly shortcoming easily.
The specific embodiment
Embodiment and the main pharmacodynamics that provides below in conjunction with the inventor, the present invention is described in further detail for the acute toxicity test data.
The medicine that is used for the treatment of the chronic cheilitis disease of the present invention, be through damp and hot at stomach, the diseases caused by exogenous pathogenic factor ailment said due to cold or exposure, wind heat is fought mutually and is formed, with the passing of time the living wind of dryness-transformation is main diseases thereby development, selects the Radix Rehmanniae, Radix Saposhnikoviae, Radix Angelicae Sinensis, Herba Schizonepetae, Radix Salviae Miltiorrhizae, Radix Scrophulariae, Rhizoma Cyperi, Oletum Trogopterori, Herba Houttuyniae, the Radix Angelicae Dahuricae ten flavor Chinese crude drug prescription compatibilities in its prescription for use; Preparation method is that Herba Schizonepetae is extracted volatile oil; Radix Salviae Miltiorrhizae, Rhizoma Cyperi ethanol extraction concentrate and reclaim ethanol, and thick paste is standby; All medicinal residues are added all the other medical material water boiling and extraction, concentrated extracting solution, and two kinds of thick paste mixings, drying is granulated, and granulate adds volatile oil, and the packing explained hereafter goes out patent medicine.
It is intercalation that chronic exfoliative cheilitis is equivalent to the exfoliative inflammation of the lips, the lip order of Chinese medicine.Be to itch bitterly with lip, dry desquamation, crowfoot cracks are the oral disease of main performance, outbreak repeatedly, the course of disease can reach a few days to the several years.The spleen being the foundation of acquired constitution is had one's ideas straightened out in mouth, and its China is at lip, and " element asks that the five internal organs generate a piece of writing " cloud: " the tissue connected with the spleen being muscle, its flourish lip also." prosperity and decline of function that lip can reflect that The spleen has the function to transport and transform nutrients, the healthy and vigorous then lip of the vital essence of spleen is ruddy.Thereby lip is disease, many duties in spleen.Say in " the surgery card is controlled pandect ": " exfoliative inflammation of the lips, name lip order is intercalation, how at lower lip, just itches red and swollen, and the flowing water that with the passing of time breaks aches and burns as fire, does not seemingly have Pi Zhizhuan, and this spleen channel blood is also dry.Then order is intercalation moving frequently as wind-dryness." point out that the exfoliative inflammation of the lips is dry with spleen channel blood, wind-dryness is relevant.The multifactor body blood deficiency of primary disease, or the strong weary source of not enough hemopoietic of receiving of taking the photograph of insufficiency of the spleen mistake, it is dry that blood deficiency is with the passing of time then given birth to air slaking, the dry heat of then giving birth to, scorching follow through on attack lip, local coagulation of QI-blood and falling ill, causing swelling of the lips shows effect repeatedly, heals for a long time and not.The mistake of blood deficiency lip is moistened foster, and with the passing of time wind, then xerocheilia, pruritus, desquamation are given birth in dryness-transformation.Pallor is simple and unadorned, oliguria, and big dry stool, the few Tianjin of light red tongue dry tongue, thready and rapid pulse is all resembling of blood deficiency heat-transformation.We's method of treatment is the yin nourishing of dispeling the wind, activating blood circulation to dissipate blood stasis.We are monarch drug with the yin nourishing of dispeling the wind of the Radix Rehmanniae, Radix Saposhnikoviae, Radix Angelicae Sinensis, cure mainly the card of deficiency of YIN wind heat.Herba Schizonepetae, Radix Salviae Miltiorrhizae, Radix Scrophulariae principal drug assistance expelling wind and activating blood circulation are ministerial drug.Assistant is with Rhizoma Cyperi, Oletum Trogopterori, Herba Houttuyniae endogenous wind-evil caused by sthenic liver-energy).With the Radix Angelicae Dahuricae for making coordinating the actions of various ingredients in a prescription.The function of medical material of respectively distinguishing the flavor of in the side is as follows:
The Radix Rehmanniae, cool in nature, sweet in the mouth is gone into the heart, liver, kidney channel, can removing heat from blood, again can YIN nourishing, have YIN nourishing, cooling blood for hemostasis, the effect of promoting the production of body fluid to quench thirst.Modern pharmacological research shows that the Radix Rehmanniae has radioprotective, protects the liver blood sugar lowering.Heart tonifying, hemostasis, diuresis, antifungal effect.
Radix Saposhnikoviae, gas is special, and it is little sweet, warm in nature to distinguish the flavor of.Go into bladder, liver, spleen channel, inducing diaphoresis to dispel wind is arranged, win the effect of wet relieving convulsion.Be used for the treatment of cold, headache, general aching, anemofrigid-damp arthralgia, arthralgia, itchy skin eruption, diseases such as urticaria.
Radix Angelicae Sinensis, sweet in the mouth, suffering, little hardship, warm in nature, return liver, the heart, spleen channel.Main effect is invigorated blood circulation menstruction regulating and pain relieving, loosening bowel to relieve constipation for enriching blood.Be used for blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia.
Herba Schizonepetae, acrid in the mouth, slightly warm in nature.Return lung, Liver Channel, main effect is the diffusing wind that induces sweat, rash.
Radix Salviae Miltiorrhizae, bitter in the mouth, cold nature, GUIXIN, pericardium, Liver Channel.The function blood circulation promoting and blood stasis dispelling, nourishing blood to tranquillize the mind, removing heat from blood eliminating carbuncle, menstruction regulating and pain relieving.Be the most frequently used blood system medicine, as Zhang Bingcheng what is called " though Radix Salviae Miltiorrhizae has ginseng name, the power deficiency of enriching blood, the merit of invigorating blood circulation is had a surplus, and is medicine first of the conditioning blood system " " book on Chinese herbal medicine is just read ".Because the action range of Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling is and reliable, the efficacy of a drug is steady, modern with as medicine first choice of the blood circulation promoting and blood stasis dispelling.
Radix Scrophulariae, it is little salty to distinguish the flavor of, and cold nature is returned kidney channel.Effect is that nourishing YIN to lower pathogenic fire, benefit are smart, convenient, can control the calentura excessive thirst, and is also effective to laryngopharynx swelling and pain, spontaneous sweating, haematemesis nose bleeding, the withered constipation in Tianjin, vexatious insomnia.
Rhizoma Cyperi, acrid in the mouth, little hardship, little sweet are returned liver, spleen, tri-jiao channel.Effect is promoting QI circulation for relieving depression, menstruction regulating and pain relieving.Oletum Trogopterori has invigorating blood circulation, changes silt, the analgesic effect.
Herba Houttuyniae, acrid in the mouth, cold nature.Return lung meridian.Effect is a heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus, inducing diuresis for treating stranguria syndrome.
The Radix Angelicae Dahuricae, acrid in the mouth, warm in nature.Return stomach, large intestine, lung meridian.The wind that looses dehumidifies understand things pain-stopping, detumescence and apocenosis.Be used for headache due to common cold, supraorbital bone pain, nasal obstruction, nasal sinusitis, toothache, leucorrhea, skin infection swells and ache.With for making coordinating the actions of various ingredients in a prescription.
Take a broad view of full side, select YAOJING to practice, compatibility degree of having, monarch, primary and secondary is suitable.Play the yin nourishing of dispeling the wind altogether, the merit of activating blood circulation to dissipate blood stasis.
Through the modern Chinese medicine pharmacological research, monarch drug in the Radix Rehmanniae system side, main component is iridoid glycoside such as catalpol (catalpol) and saccharide etc., its pharmacology antiinflammatory action research: irritating stomach with the Radix Rehmanniae decoct all has tangible antagonism to rat formaldehyde arthritis and albumen arthritis, and can suppress the increase of the capillary permeability that granuloma that the Oleum Terebinthinae subcutaneous injection causes and histamine cause, employing mouse peritoneum inflammation, methods such as the vascular permeability increase that histamine causes have been observed the water of bosom Radix Rehmanniae, alcohol, the antiinflammatory action of ether extracting solution, find that the Radix Rehmanniae aqueous extract has obvious inhibitory action to the mouse peritoneum inflammation that vascular permeability increases and acetic acid causes that histamine causes, acute inflammation due to the Ovum Gallus domesticus album is also had antiinflammatory action, and alcohol of Radix Rehmanniae and ether extracting solution there is not the antiinflammatory effect.Radix Saposhnikoviae: mainly contain the chromone constituents: cimifugin (cimifugin), cimicifugoside (prim-O-glucosylcimifugin) etc.; Its pharmacological action mainly is an antiinflammatory action and to Immune Effects, Radix Saposhnikoviae water decoction 20g/kg lumbar injection or 40g/kg irritate stomach Oleum Tiglii mixture induced mice ear inflammation are had the obvious anti-inflammatory and anti effect, Radix Saposhnikoviae water decoction 20g (crude drug)/kg, irritate stomach every day 1 time, continuous 4 days, can significantly improve phagocytic percentage and phagocytic index that Turnover of Mouse Peritoneal Macrophages is engulfed chicken red blood cell.Radix Angelicae Sinensis: mainly contain volatility and involatile constituent, pharmacological research shows: Radix Angelicae Sinensis water decoction 100mg/ml～500mg/ml, can suppress ADP and collagen-induced rat platelet aggregation in vitro; Water decoction of Angelica sinensis can significantly promote hemoglobin and erythrocytic generation to mice is oral.Radix Scrophulariae, promptly Radix Scrophulariae also contains the iridoid glycoside constituents, and to trichophyton mentagrophytes, acrothesium floccosum and ulotrichy microspore tinea bacterium have certain inhibitory action to the Radix Scrophulariae water decoction external.Oletum Trogopterori contains catechol (catechol), benzoic acid (benzoic acid) etc., and the Oletum Trogopterori water extract is external can significantly to be suppressed by ADP and the inductive rabbit platelet aggregation of collagen, and depression effect is relevant with dosage, its IC
50Be respectively 225ug/ml, 56ug/ml, Herba Houttuyniae contains volatile oil and sweet class, and Herba Houttuyniae decoct and houttuynine sodium bisulfite all can strengthen leukocytic phagocytic function; The Radix Angelicae Dahuricae contains multiple Coumarins composition and multiple inorganic elements, and Radix Angelicae Dahuricae decoct 4g (crude drug)/kg irritates stomach, and xylol induced mice ear inflammation has obvious inhibitory action.Radix Salviae Miltiorrhizae, mainly contain fat-soluble Diterpenes composition and water miscible phenolic acid composition, Radix Salviae Miltiorrhizae water decoction and alcohol extract are all influential to blood system, Rhizoma Cyperi, contain saccharide and volatile oil, cyperol extract 100mg/kg lumbar injection, on Carrageenan and formaldehyde-caused rat swelling of the feet have the obvious suppression effect, and the effective ingredient of antiinflammatory action is triterpenoid compound (IV-B).Herba Schizonepetae is mainly volatile oil, and Herba Schizonepetae water decoction 20g (crude drug)/kg lumbar injection is coated with Oleum Tiglii to the mouse ear face and mixes and to cause scorching reaction obvious inhibitory action is arranged.Herba Schizonepetae water decoction 14g (crude drug)/kg lumbar injection injects to mouse peritoneal that the capillary permeability increase has obvious inhibitory action due to the 0.7% acetic acid 10ml/kg.Herba Schizonepetae volatile oil main component pulegone 100mg/kg irritates stomach, and the suppression ratio that the abdominal cavity is oozed out is 39.8%, and its antiinflammatory action intensity and aminophenazone are about equally.By modern medicinal agents gain knowledge research think the medicine that is used for the treatment of the chronic cheilitis disease of the present invention.It is the choice drug of treatment chronic cheilitis.
Preparation embodiment 1: preparation cheilitis granule
Cheilitis granule prescription by the Radix Rehmanniae, Radix Saposhnikoviae, Radix Angelicae Sinensis, Herba Schizonepetae, Radix Salviae Miltiorrhizae, Radix Scrophulariae, Rhizoma Cyperi, Oletum Trogopterori,
Herba Houttuyniae, the Radix Angelicae Dahuricae ten flavor Chinese crude drugs are formed each prescription medicine optimum content and degree such as following table:
| The Chinese crude drug title | The Radix Rehmanniae | Radix Saposhnikoviae | Radix Angelicae Sinensis | Herba Schizonepetae | Radix Salviae Miltiorrhizae | Radix Scrophulariae | Rhizoma Cyperi | Oletum Trogopterori | Herba Houttuyniae | The Radix Angelicae Dahuricae |
| Weight in the prescription (g) | 750 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 1500 | 500 |
| Degree in the prescription (%) | 12 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 24 | 8 |
2. cheilitis preparation method of granules
Each medical material roguing is weighed in will writing out a prescription, and Herba Schizonepetae is extracted volatile oil, and extracting liquid filtering is standby; Radix Salviae Miltiorrhizae, Rhizoma Cyperi are extracted 2 times with 4.5 times of amounts of 85% ethanol, extract 2 hours at every turn, merge ethanol extract, filter, and reclaim ethanol, and alcohol extract concentrates standby; Medicinal residues and other medical materials add 12 times of water gagings, decoct 3 times, and each 1 hour, collecting decoction filtered, and added Herba Schizonepetae water extract, and filtrate is concentrated, adds the alcohol extraction concentrated solution again, and the thick paste that is concentrated into relative density and is 1.25～1.30 (50 ℃) is standby; Get 3.6kg dextrin and 9kg cane sugar powder mix homogeneously, in mixer by thick paste: sucrose: dextrin=1:2.5:1 feeds intake, and adds an amount of ethanol system soft material; with waving the machine-processed granule of granulating,, cross 10 mesh sieve granulate in 65 ℃ of dryings; add volatile oil, airtight, carry out packing promptly then.Every packed 12g adorns 1000 bags altogether.
3. cheilitis granule instructions of taking and consumption: oral, one time one bag of being grown up, 3 times on the one, warm boiled water; The child is cut down according to the circumstance, or follows the doctor's advice.
Preparation embodiment 2:
Different is for present embodiment and embodiment 1, and the weight of prescription and percentage ratio is difference to some extent, and all the other are with embodiment 1, its each prescription content and degree are: the Radix Rehmanniae: 11%, and Radix Saposhnikoviae: 9%, Radix Angelicae Sinensis: 8%, Herba Schizonepetae: 9%, Radix Salviae Miltiorrhizae: 7%, Radix Scrophulariae: 9%, Rhizoma Cyperi: 9%, Oletum Trogopterori: 8%, Herba Houttuyniae: 23%, the Radix Angelicae Dahuricae: 7%, the percentage ratio sum of above-mentioned medical material is 100%.
Preparation embodiment 3:
Different is for present embodiment and embodiment 1, and the weight of prescription and percentage ratio is difference to some extent, and all the other are with embodiment 1, its each prescription content and degree are: the Radix Rehmanniae: 13%, and Radix Saposhnikoviae: 8%, Radix Angelicae Sinensis: 7%, Herba Schizonepetae: 8%, Radix Salviae Miltiorrhizae: 9%, Radix Scrophulariae: 8%, Rhizoma Cyperi: 8%, Oletum Trogopterori: 7%, Herba Houttuyniae: 24%, the Radix Angelicae Dahuricae: 8%, the percentage ratio sum of above-mentioned medical material is 100%.
Certainly, the foregoing description can also be enumerated, and adjusts a little in the scope that the present invention provides, and all can prepare qualified cheilitis granule.
The applicant has carried out animal acute toxicity test and Pharmacodynamic test of active extract to the prepared cheilitis granule of embodiment, specifically tests as follows:
First: cheilitis granule animal acute toxicity test
One, test objective
Acute toxic reaction and the death condition of animal behind the observation cheilitis granule gastric infusion.
Two, test material
1.1. trial drug
Cheilitis granule thick paste (not adding excipient) is provided by TCM Preparation Room, pitchy, and product batch number: 080220,1g is equivalent to the 2g crude drug.Intend clinical people's consumption: oral, granule: every day 3 times, each 12g, the 1g thick paste is equivalent to the 4g granule, and in body weight for humans 60kg, people's consumption: 0.15g thick paste/kg is equivalent to 0.3g crude drug/kg.It is standby to be made into 50% suspension with distilled water.2. experimental animal
Kunming kind white mice, male and female half and half, body weight 18～22g is provided by The Fourth Military Medical University of P.L.A's Experimental Animal Center.Animal eats solid feed by the sex sub-cage rearing, the drinking water freedom, and feedstuff is provided by this school Experimental Animal Center.18～20 ℃ of room temperatures, relative humidity 60%～70%.
Three, test method and result
1. gastric infusion acute toxicity test
1.1 test prerun:
12 of white mice, ♀ ♂ half and half is divided into 2 groups at random, and 6 every group, fasting is after 12 hours, irritates stomach respectively and gives cheilitis thick paste suspension 0.3ml/10g * 1 time, and 0.3ml/10g * 2 time 6 hours at interval, were observed 7 days.The result does not have dead mouse, and prompting can not be measured LD
50So, measure mice maximum dosage-feeding on the one.
1.2 formal test:
Other gets 20 of mices, ♀ ♂ half and half, and fasting was irritated stomach and is given cheilitis granule suspension 0.3ml/10g after 12 hours, and 2 times on the one, 6 hours at interval.The accumulative total dosage is 0.6ml/10g in one day, observes 7 days.In the administration 1 hour, mice the different activity of degree occurs and reduces, the basic recovery normally after 1 hour.All the other viewing durations, the mice hair luster, activity freely, the feed and large and small just normal, find no other toxic reactions.The weight of animals increases after 7 days, increases to 22.5 ± 1.9g by 19.9 ± 1.8g before the administration, and mice does not have death.Mice was put to death in the cervical vertebra dislocation when experiment finished, and dissected perusal main organs color and morphological change, and main organs no abnormality seens such as the heart, liver, spleen, lung, kidney, stomach, intestinal change as a result.In view of the above, cheilitis granule mouse stomach maximum dosage-feeding on the one is a 120g/kg (conversion 60g crude drug/kg).
2. conclusion
Cheilitis granule mouse stomach maximum dosage-feeding on the one is 60g crude drug/kg, be equivalent to 200 times of clinical adult's consumptions every day (adult's consumption=1 every day bag/time * 3 times/day * 12g/ bag * 0.5g crude drug/gram ÷ 60kg=0.3g crude drug/kg).Illustrate that oral administration is safe.
First: pharmacodynamics test
One, experiment purpose:
Observe the cheilitis granule by Pharmacodynamic test of active extract and cure mainly relevant pharmacological action, for clinical application provides test basis with clinical function.
Two, experiment material
1. medicine and reagent
1.1 cheilitis granule (not adding excipient):
Provide by Pharmacy department of Stomatological Hospital, Military Surgeon Univ. No. 4.The thick paste of pitchy, product batch number: 20071108,1g is equivalent to the 2g crude drug.Intend clinical people's consumption: oral, granule: every day 3 times, each 5g, the 1g thick paste is equivalent to the 1.42g granule, and in body weight for humans 60kg, people's consumption: 0.176g thick paste/kg is equivalent to 0.352g crude drug/kg.
1.1.2 kouyanqing granules:
Produced by Guangzhou Baiyunshan Heji Huangpu Chinese Medicine Co., Ltd., function cures mainly: nourishing YIN and clearing away heat, removing toxic substances and promoting subsidence of swelling are used for the oral inflammation due to the hyperactivity of fire caused by deficiency of YIN.Lot number: 20071204, every bag of 10g, usage and dosage: oral, one time 2 bags (20g), 1-2 time on the one.It is people's consumption 0.67g/kg. day.It is 200% that maximum can be irritated stomach concentration.
1.3 indometacin:
Linfen mound pharmaceutical Co. Ltd has antiinflammatory, analgesic and analgesic activity.Specification: 25mg, lot number: 060901.
1.4 aspirin:
Bailu Pharmaceutical Co., Ltd., Shaanxi.Specification: 25mg, lot number: 071129.
2. animal and instrument
2.1 animal:
KM mice, body weight are 18g-22g, and Xi'an Communications University's Experimental Animal Center provides, the up-to-standard credit number of mice: SCXK (Shan) 2007-001 number, SD rat, 180g-220g, provide the quality certification of rat number by The Fourth Military Medical University's Experimental Animal Center: the moving card of doctor word 08-005 number.
2.2 instrument:
YLS-7B foot sole of the foot volumetric measurement instrument, YLS-12A Mus tail illumination dolorimeter, the YLS-6B hot-plate instrument is provided by equipment station, the Academy of Medical Sciences, Shandong.The hematological indices CD-1600 of Abbott Laboratories instrument.
2.2.3 experimental condition:
Room temperature 20-24 ℃, about relative air humidity 45-65%, the air-conditioning homoiothermic, exhaust fan ventilates, and male and female divide cage to feed, and keeps clean and tidy, swept Mus house in every 2-3 days, light/dark time is 12/12 hour three, the selection foundation of test dose and the statistical method of experimental result
This product is The Fourth Military Medical University of P.L.A's hospital preparation kind, intends clinical people's consumption: oral, and granule: every day 3 times, each 5g, the 1g thick paste is equivalent to the 1.42g granule, in body weight for humans 60kg, people's consumption: 0.176g thick paste/kg is equivalent to 0.352g crude drug/kg.Pharmacodynamics test dosage is designed to after test: rat: 18g crude drug/kg, 9 crude drugs/kg, 4.5g crude drug/kg are equivalent to clinical plan 51 times, 25.5 times, 12.5 times with dosage.Mice: 36g crude drug/kg, 18 crude drugs/kg, 9g crude drug/kg are equivalent to clinical plan 101 times, 51 times, 25.5 times with dosage.Positive drug kouyanqing granules rat 34g granule/kg (being equivalent to clinical plan 51 times), mice: 40g granule/kg (maximum dosage-feeding is equivalent to clinical plan 60 times with dosage) with dosage.
(test data of the expression of X ± S) carries out the t check between group, organize an x between the data set of representing with the reaction percentage rate with means standard deviation
2The check of grade preface value method is adopted in check, ranked data, and with the significance of check medicine, statistical software adopts NDST new drug statistical procedure (Yuan Bingxiang compiles for Sun Ruiyuan, Cheng Nengneng).
Four, experimental technique and result
1. the influence of rat oral ulcer due to the Pyrogentisinic Acid
1.1.1 experimental technique:
Get 50 of SD rats, ip10% urethane 1mL/100g anesthesia, the plastic dropper lower end that will contain 90% phenol cotton balls is flat on the about 1mm of the rats with left bicker place cheek film, and calcination 40s promptly sees this place's white damage.Be divided into 5 groups behind the 24h at random, 10 every group, male and female half and half: water matched group, cheilitis are particulate big, in, little 3 dosage groups: 18g crude drug/kg, 9g crude drug/kg, 4.5g crude drug/kg, positive control drug KOUYANQING 34g/kg, gastric infusion according to dosage, every day 1 time, continuous 7 days.
Observation index:
1. observe the long-pending size of ulcer (in the ulcer diameter) and ulcer healing situation (the visible ulcer of no meat is considered as healing) next day before the administration and after each administration;
2. survey body weight, food ration and the water uptake of rat every day.
3. get blood and survey leukocyte and the classification thereof of rat,
4. put to death rat, take by weighing liver, spleen and thymic weight, calculate organ index.
5. get the rat buccal mucosa, 8d takes off neck with rat and puts to death, get right side bicker tissue and fix, carry out pathological examination, carry out classification according to pathomorphism change degree with 10% formalin, the severe pathological changes: incisxal edge is seen ulcer surface, epithelial defect, ulcer reach flesh layer depth portion, a large amount of cell infiltration of lamina propria, flesh layer edema, muscle layer tissue's degeneration necrosis; Slight pathological changes: lamina propria edema, vasodilation hyperemia, flesh layer edema, cell infiltration, connective tissue proliferation, muscle layer tissue's mild degeneration and necrosis; Normally: do not see pathological change.
1.2 experimental result
1.2.1 the influence of rat oral ulcer area due to the Pyrogentisinic Acid:
Compare with the modeling group, cheilitis granule heavy dose all has significantly reducing in various degree (P＜0.05-P＜0.001) at 2 days-7 days ulcer areas, 6 days-7 days ulcer areas of dosage all have significantly reducing in various degree (P＜0.05) in the cheilitis granule, and KOUYANQING significantly reduces (P＜0.05) at 7 days ulcer areas.Results suggest: the cheilitis granule has the healing effect of rat oral ulcer due to the remarkable promotion phenol.The results are shown in Table 1.
The influence of rat oral ulcer area due to the table 1 cheilitis granule Pyrogentisinic Acid (X ± s, n=10)
Annotate: compare * P＜0.05, * * P＜0.01, * * * P＜0.001 with matched group
2. the influence of rat oral ulcer surface healing rate due to the Pyrogentisinic Acid:
Compare with the modeling group, heavy dose of 5 days-7 days of cheilitis granule, 7 days rat oral ulcer surfaces of middle dosage healing rate all has remarkable rising (P＜0.05) in various degree.Results suggest: the cheilitis granule has the effect that significantly improves ulcer rat oral ulcer surface healing rate.The results are shown in Table 2.
The influence of rat oral ulcer healing rate due to the table 2 cheilitis granule Pyrogentisinic Acid (X ± s, n=10)
Annotate: compare * P＜0.05 with matched group
1.2.3 the influence of oral ulcer rat healing rate due to the Pyrogentisinic Acid:
With the modeling group relatively, the cheilitis granule all has in various degree rising to the ulcer rat healing rate, big or middle dosage group has significant difference (P＜0.05).Results suggest: the cheilitis granule has the effect that significantly improves the ulcer rat healing rate.The results are shown in Table 3.
1.2.4 the influence of oral ulcer rat healing time due to the Pyrogentisinic Acid:
Cheilitis granule and modeling group compare, and the healing time of ulcer rat all has shortening in various degree, and heavy dose of group has significant difference (P＜0.05).Results suggest: the cheilitis granule has remarkable shortening and scalds the effect of rat healing time.See Table 3.
The influence of table 3 oral ulcer rat healing rate (X ± s, n=10)
Annotate: compare * P＜0.05 with matched group
1.2.5 the oral ulcer rat blood is learned the influence of index due to the Pyrogentisinic Acid:
Experimental result shows that the cheilitis granule does not have obviously influence to oral cavity ulcer rat total white blood cells and classification thereof, the results are shown in Table 4.
The influence of oral ulcer rat leukocyte and classification thereof due to the table 4 cheilitis granule Pyrogentisinic Acid (X ± s)
1.2.6 oral ulcer rat body weight due to the Pyrogentisinic Acid, food ration, the influence of water uptake and organ index:
Cheilitis granule and modeling group compare, to rat body weight, and food ration, water uptake and organ index do not have obvious influence.Results suggest: oral ulcer rat body weight due to the Pyrogentisinic Acid, food ration, water uptake and organ index do not have obvious influence.The results are shown in Table 5, table 6, table 7.
Oral ulcer rat body weight influence ((X ± s, n=10)) due to the table 5 cheilitis granule table Pyrogentisinic Acid
The influence ((X)) of oral ulcer rat food ration and water uptake due to the table 6 cheilitis granule table Pyrogentisinic Acid
The exponential influence of oral ulcer Rats Organs and Tissues due to the table 7 cheilitis granule table Pyrogentisinic Acid (X ± S)
| Group | Number of animals (only) | Dosage (g/kg) | Liver (g/100g) | Spleen (g/100g) | Thymus (g/100g) |
| Model group | 10 | 4.60±0.21 | 0.25±0.05 | 0.14±0.07 | |
| The cheilitis granule | 10 | 4.5 | 4.83±0.30 | 0.23±0.03 | 0.13±0.03 |
| The cheilitis granule | 10 | 9.0 | 4.60±0.31 | 0.22±0.03 | 0.13±0.03 |
| The cheilitis granule | 10 | 18 | 4.69±0.47 | 0.23±0.03 | 0.13±0.03 |
| KOUYANQING | 10 | 34 | 4.61±0.34 | 0.23±0.05 | 0.14±0.03 |
1.2.7 the histological influence of rat oral ulcer pathology due to the Pyrogentisinic Acid:
3 dosage of cheilitis granule and modeling group are relatively, the rat oral ulcer there is in various degree improvement, heavy dose of group has significant difference (P＜0.05), KOUYANQING also has the effect (P＜0.05) of significant treatment oral ulcer, results suggest: the cheilitis granule has the healing effect of remarkable promotion rat oral ulcer pathological changes.The results are shown in Table 5.
Table 8 cheilitis granule is to the influence of rat oral ulcer histo pathological change
| Group | Number of animals (only) | Dosage (g/kg) | The severe pathological changes | Slight pathological changes | Normally |
| Model group | 10 | 5 | 4 | 1 | |
| The cheilitis granule | 10 | 4.5 | 1 | 7 | 2 |
| The cheilitis granule | 10 | 9.0 | 1 | 6 | 3 |
| The cheilitis granule | 10 | 18 | 0 | 5 | 5 * |
| KOUYANQING | 10 | 34 | 0 | 6 | 4 * |
Annotate: compare * P＜0.05 with matched group
2. the cheilitis granule causes the analgesic effect of mice stomachache to glacial acetic acid:
2.1 experimental technique:
Get KM mice 18-24g, 72, male and female half and half, be divided into 6 groups at random by the body weight sex, 12 every group, water matched group, cheilitis are particulate big, in, little 3 dosage groups: 36g crude drug/kg, 18g crude drug/kg, 9g crude drug/kg, indometacin 15mg/kg, KOUYANQING 40g/kg, according to dosage gastric infusion, every day 1 time, continuous 5 days, indometacin was only at gastric infusion on the same day, last administration 45min, every Mus ip0.7% glacial acetic acid 0.1ml/10g body weight, behind the 5min in the opening entry 10min mice turn round the body number of times.2.2 experimental result:
Cheilitis granule heavy dose, middle dosage and KOUYANQING and water matched group relatively have the effect (P＜0.05) that significant minimizing animal is turned round the body number of times.See table 9 for details.The experimental result prompting: the cheilitis granule causes mice stomachache to glacial acetic acid and has significant analgesic activity.
Table 9 cheilitis granule causes the analgesic effect (X ± S) of mice stomachache to glacial acetic acid
| Group | Number of animals (only) | Dosage (crude drug g/kg) | Turn round the body number of times (inferior/10min) | Suppression ratio (%) |
| The water matched group | 12 | 28±12 | ||
| The cheilitis granule | 12 | 9 | 18±12 | 35.7 |
| The cheilitis granule | 12 | 18 | 20±11 | 28.6 |
| The cheilitis granule | 12 | 36 | 17±9 * | 39.3 |
| Indometacin | 12 | 0.015 | 14±6 * | 50.0 |
| KOUYANQING | 12 | 40 | 14±8 * | 50.0 |
Annotate: compare * P＜0.05 with the water matched group
3. thermostimulation is caused the analgesic effect (tail-flick method) of mice pain
3.1 experimental technique:
KM mice body weight 20g-23g, screen with Mus tail illumination dolorimeter: reject less than 3s or greater than 10s person the threshold of pain, select 66 of qualified mices, male and female half and half, be divided into 6 groups at random by the body weight sex, every group 11, the water matched group, cheilitis is particulate big, in, little 3 dosage groups: 36g crude drug/kg, 18g crude drug/kg, 9g crude drug/kg, indometacin 15mg/kg, KOUYANQING 40g/kg, gastric infusion according to dosage, every day 1 time, continuous 5 days, indometacin was only at gastric infusion on the same day, last administration 45min, afterbody is from terminal 2.5cm place, with 45min after the administration of Mus tail illumination dolorimeter mensuration, the mice whipping time of 1h and 2h (being placed on the illumination hole to the time of mice) because of thermostimulation pain whipping from mouse tail, in the test if irradiation 12.5s does not still interrupt irradiation during whipping, in order to avoid local the scald, and in 12.5s, with pain incubation period whipping time of mice as mice, the analgesic activity of expression medicine.
2.2.2 experimental result:
With the water matched group, the heavy dose of group of cheilitis granule is behind medicine when 0.5h, 1h and 2h, in dosage behind medicine, all have effect (P＜0.05 of significant prolongation mice TFL during 1h, P＜0.01), indometacin all has effect (P＜0.01 of significant prolongation mice TFL when 1h and 2h behind medicine, P＜0.05), experimental result prompting: the cheilitis granule causes mice pain to thermostimulation and has the obvious suppression effect.See table 10 for details.
Table 10 cheilitis granule causes analgesic effect (the tail-flick method) (X ± s) of mice pain to thermostimulation
Annotate: compare * P＜0.05**P＜0.01 with the water matched group
4. thermostimulation is caused the analgesic effect (hot plate method) of mice pain
4.1 experimental technique:
KM mice body weight 20g-23g, screen with the hot plate dolorimeter: reject less than 10s or greater than 60s person the threshold of pain, select 66 of qualified mices, female, be divided into 6 groups at random by body weight, every group 11, the water matched group, cheilitis is particulate big, in, little 3 dosage groups: 36g crude drug/kg, 18g crude drug/kg, 9g crude drug/kg, indometacin 15mg/kg, KOUYANQING 40g/kg, according to dosage gastric infusion, every day 1 time, continuous 5 days, indometacin was only at gastric infusion on the same day, last administration 45min, with 45min after the administration of hot plate dolorimeter mensuration, the mice pain time of 1h and 2h (being placed in hot-plate instrument adds metapedes because of thermostimulation pain to mice time) from mice, in the test if still not interrupt test during pain of irradiation 60s, in order to avoid local the scald, and in 60s, add the pain incubation period of the time of metapedes with mice, the analgesic activity of expression medicine as mice.
4.2 experimental result:
With the water matched group, the big-and-middle dosage group of cheilitis granule is behind medicine during 2h, all has the preclinical effect of significant prolongation mice pain (P＜0.05), indometacin has the preclinical effect of significant prolongation mice pain (P＜0.05) during 2h behind medicine, the experimental result prompting: the cheilitis granule causes mice pain to thermostimulation and has certain inhibitory action.See table 11 for details.
Table 11 cheilitis granule causes analgesic effect (the hot plate method) (X ± s) of mice pain to thermostimulation
Annotate: compare * P＜0.05 with the water matched group
5. to the influence of rat paw edema
5.1 experimental technique
Get 60 of SD rats, body weight is 180-200g, and male and female half and half are divided into 6 groups, 10 every group.The water matched group, cheilitis is particulate big, in, little 3 dosage groups: 18g crude drug/kg, 9g crude drug/kg, 4.5g crude drug/kg, positive control drug aspirin group (200mg/kg), positive control drug Ah KOUYANQING 40g/kg, gastric infusion according to dosage, every day 1 time, continuous 5 days, last administration 45min, after the last administration 45 minutes, measure right back sufficient sole of the foot volume, only inject 1% carrageenin 0.1ml/ from the right back vola mind-set of rat ankle joint direction with sufficient sole of the foot volumetric measurement instrument, cause scorching back 2,3,4,5,6h measures sufficient sole of the foot volume respectively, calculate cause scorching before and after each the time mutually sufficient sole of the foot volume difference.
5.2 experimental result:
Compare with matched group, particulate three the dosage groups of cheilitis are causing the effect (P＜0.05-P＜0.001) that scorching back 2h all demonstrates certain inhibition pedal swelling, the aspirin group is causing scorching back 2h, 3h, 4h, 5h, 6h all demonstrate the effect (P＜0.05-P＜0.001) of stronger inhibition pedal swelling, the positive drug KOUYANQING sees table 12 for details causing the effect (P＜0.001-P＜0.05) that scorching back 2h and 5h all demonstrate certain inhibition pedal swelling.Results suggest: the cheilitis granule has certain inhibitory action to the pedal swelling of rat.
Table 12 cheilitis granule is to influence (X ± s) (n=10) of rat paw edema
Annotate: compare * P＜0.05, * * P＜0.01, * * * P＜0.001 with matched group
6. to the influence of mice ear
6.1 experimental technique
KM mice body weight 20g-23g, 72, male and female half and half, be divided into 6 groups at random by the body weight sex, every group 12, water matched group, cheilitis are particulate big, in, little 3 dosage groups: 36g crude drug/kg, 18g crude drug/kg, 9g crude drug/kg, indometacin 15mg/kg, according to dosage gastric infusion, every day 1 time, continuous 5 days, indometacin was only at gastric infusion on the same day, last administration 45min, 20 μ l dimethylbenzene are applied in mouse right ear, after 20 minutes, cut left and right ear, weigh along auricle, with ten thousand/ balance claim the weight of two auricles, be auricle swelling degree with the difference of two auricle weight.
6.2 experimental result:
The heavy dose of group of cheilitis granule compares with matched group, and the effect (P＜0.05) of certain inhibition mice ear is arranged, and positive drug and matched group comparison can significantly suppress the ear thickness (P＜0.05) of mice caused by dimethylbenzene xylene.See table 13 for details.
Table 13 cheilitis granule is to the inhibitory action of ear swelling (X ± s)
| Group | Number of animals (only) | Dosage (g/kg) | Mice ear degree (mg) | Inhibitory rate of intumesce (%) |
| The water matched group | 12 | 16.94±10.91 | ||
| The cheilitis granule | 12 | 9 | 14.80±11.88 | 12.4 |
| The cheilitis granule | 12 | 18 | 13.01±7.60 | 23.2 |
| The cheilitis granule | 12 | 36 | 8.97±6.24 * | 47.0 |
| Indometacin | 12 | 0.015 | 5.9±4.83 * | 65.2 |
| KOUYANQING | 12 | 10 | 6.27±6.60 * | 63.0 |
Annotate: compare * P＜0.05 with the water matched group
Five, conclusion
Under this experiment condition, the cheilitis granule has the healing effect of rat oral ulcer surface due to the remarkable promotion phenol, has the effect that significantly improves rat oral ulcer healing rate, has the effect that significantly improves the ulcer rat healing rate, have the effect of remarkable shortening oral ulcer rat healing time, have the healing effect of remarkable promotion rat oral ulcer pathology; The cheilitis granule causes mice stomachache to glacial acetic acid and has significant analgesic activity, thermostimulation is caused mice pain have the obvious suppression effect, and the cheilitis granule is to the pedal swelling of rat, and the ear swelling of mice has certain inhibitory action.
The particulate function of above-mentioned pharmacodynamic result and cheilitis cures mainly and matches, for further clinical practice provides the pharmacology foundation.
List of references in the experimentation:
1. medicine is evaluated the center, study of tcm new drug specification requirement, new drug reviewing file 2000.5.
2. Zhu Xuan tawny daylily, Wang Guangji, Liu Jianping etc., oral film treatment experimental rat oral ulcer Study on mechanism, Chinese medicine academic periodical, 2003,21 (1): 84-85.
3. Jiang Wang Lin, Fu Fenghua, Tian Jingwei etc., mouth ulcer lozenge be to the therapeutical effect of rat experiment oral ulcer, Chinese herbal medicine, 2003,34 (9): 835-837.
4. Lee state is new, Yang Jianhong, Li Zhifang, the experimentation of tonifying-Yin and nourishing-stomach soup treatment recurrent oral ulceration, Tianjin medicine, 2007,19 (3): 4-5.
5. open and chant prunus mume (sieb.) sieb.et zucc., Peng Fei, Yang Jiying etc., the development and the animal experiment study of the compound oral film of the SANYE mound/SD-Zn of committee, Shenzhen combination of Chinese and Western medicine magazine, 2007,17 (3): 143-145.
6. square Tai Hui, Xu Huiqin, Xu Li etc., the observation of curative effect of mouthful anti-phenol oral ulcer of healthy and free from worry chewable tablet, Nanjing University of Traditional Chinese Medicine's journal, 1996,12 (5): 24-26.
7. Shandong Kodak, Wang Xinchang, Zhang Bingbing etc., the rather research of the experimental oral ulcer effect of soup effective ingredient, middle Zhejiang University of Traditional Chinese Medicine journal, 2007,31 (3): 303-304.
Claims (3)
1. a medicine that is used for the treatment of the chronic cheilitis disease is characterized in that, this medicine that makes is made up of the effective ingredient of following medical material, the percentage by weight of medical material is: the Radix Rehmanniae: 11%～13%, and Radix Saposhnikoviae: 7%～9%, Radix Angelicae Sinensis: 7%～9%, Herba Schizonepetae: 7%～9%, Radix Salviae Miltiorrhizae: 7%～9%, Radix Scrophulariae: 7%～9%, Rhizoma Cyperi: 7%～9%, Oletum Trogopterori: 7%～9%, Herba Houttuyniae: 23%～25%, the Radix Angelicae Dahuricae: 7%～9%, the percentage ratio sum of above-mentioned Chinese medicine medical material is 100%.
2. the medicine that is used for the treatment of the chronic cheilitis disease as claimed in claim 1 is characterized in that, this medicine that makes is made up of the effective ingredient of following medical material, the percentage by weight of medical material is: the Radix Rehmanniae: 12%, and Radix Saposhnikoviae: 8%, Radix Angelicae Sinensis: 8%, Herba Schizonepetae: 8%, Radix Salviae Miltiorrhizae: 8%, Radix Scrophulariae: 8%, Rhizoma Cyperi: 8%, Oletum Trogopterori: 8%, Herba Houttuyniae: 24%, the Radix Angelicae Dahuricae: 8%, the percentage ratio sum of above-mentioned Chinese medicine medical material is 100%.
3. the described preparation method that is used for the treatment of the medicine of chronic cheilitis disease of claim 1 is characterized in that, comprises the following steps:
Step 1 is extracted volatile oil with the Herba Schizonepetae in the prescription, and the Herba Schizonepetae water extract behind the extraction volatile oil is standby;
Step 2 is 85% ethanol extraction 2 times with Radix Salviae Miltiorrhizae, Rhizoma Cyperi in the prescription with mass fraction, extracts 2 hours at every turn, its alcoholic acid addition is Radix Salviae Miltiorrhizae and Rhizoma Cyperi 4.5 times, merges ethanol extract, filters, reclaim ethanol, it is standby to get the ethanol thick paste after alcohol extract concentrates;
Step 3, other medical material in medicinal residues behind Radix Salviae Miltiorrhizae and the Rhizoma Cyperi ethanol extraction and the prescription is decocted with water 3 times, and each 1 hour, amount of water was 12 times of other medical material weight in medicinal residues and the prescription, collecting decoction, filter, add Herba Schizonepetae water extract, filtrate concentrates, add the ethanol thick paste again, under 50 ℃ of conditions, be concentrated into relative density and be 1.25～1.30 thick paste, and make the thick paste powder;
Step 4, other gets dextrin and cane sugar powder, by the thick paste powder: sucrose: dextrin=feed intake at 1: 2.5: 1, add an amount of ethanol and make soft material, dry under 65 ℃ of conditions after granulating, cross 10 mesh sieves then, granulate, add volatile oil, airtight, patent medicine is made in packing.
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| 张红梅.浅析慢性唇炎的中医辨证施治.《陕西中医学院学报》.2003,第26卷(第1期),43-44. * |
| 郑蓉.唇炎的中医辨证治疗.《四川中医》.2006,第24卷(第8期),81. * |
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