CN1843435A - Itch-stopping cicada formulation and its preparation method - Google Patents
Itch-stopping cicada formulation and its preparation method Download PDFInfo
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- CN1843435A CN1843435A CNA2006100082755A CN200610008275A CN1843435A CN 1843435 A CN1843435 A CN 1843435A CN A2006100082755 A CNA2006100082755 A CN A2006100082755A CN 200610008275 A CN200610008275 A CN 200610008275A CN 1843435 A CN1843435 A CN 1843435A
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- cicada
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Abstract
The invention relates to an antipruritic preparation for heat clearing and detoxicating, and its preparing process, wherein the preparation is prepared from sixteen kinds of Chinese medicinal herbs including patchouli, honeysuckle flower, capsule of weeping forsythia, dahurian angelica root, sweet wormwood through the steps of vapor distillation and extraction, palletizing, drying and mixing homogenously.
Description
Technical field
The present invention relates to a kind of itching relieving Chinese medicine composition that dries, a kind of itch-stopping cicada formulation and preparation method thereof of more specifically saying so with heat-clearing and toxic substances removing, dampness removing to stop itchin.
Background technology
Skin pruritus is a common clinical, and many methods disease is the clinical manifestation of various skin disease.The many heresies by diseases caused by exogenous pathogenic factor six climate exopathogens " wind, cold, summer-heat, wet, dry, fire " of the skin pruritus that is caused by heat syndrome are attacked human body or internal organs excess-heat, accumulate strongly fragrant skin, interior must not catharsis, due to must not reaching thoroughly outward.China southern climates is hot moist, and boreal climate is cold dry, and " the strongly fragrant pathogenic heat that turns to for a long time of cold-evil ", " heresy of cold-damp strongly fragrant turn to for a long time damp and hot ", very general by the skin pruritus that damp and hot, wind heat, heat in blood cause.Ancient Chinese medicine doctor is according to the different pattern of syndrome of skin pruritus, adopt respectively and dispel the wind, dampness, the heat clearing away treatment, and adopt external treatment more, affected part is put on the skin outward, fumigation in treating " is controlled its and not Zhi Qinei outward; come down to not Zhi Qiben of Zhi Qimo ", must eradicate paathogenic factor wind internally, wet, pathogenic heat, western medical treatment adopts antihistamine drug more, the normal generation of this class medicine is drowsiness, xerostomia, side effect such as dizziness, known to looking into newly, though doctor periodical is gone up the prescription clinical practices that some treatment skin prurituss are arranged and the report of hospital preparation in recent years, and similar oral Chinese patent medicine is not also arranged in the market, therefore the skin pruritus that heat symptom-complex is caused adopts Chinese Traditional Medicines treatment for oral administration to carry out systematic research to be extremely important.
Medicine for external use is in the majority in the prior art, and it can only take stopgap measures, and the unrooted removing solid capacity must for oral administrationly be adjusted treatment, just can effect a permanent cure.The at present commercially available antipruritic medicament of heat-clearing and toxic substances removing only adopts the method for decocting with water to extract its effective ingredient to each Chinese medicinal ingredients in the prescription, and the utilization rate of its medical material is not high, does not reach ideal effect.
The Chinese patent literature application number is 99126845.8, and (applying date is December in 1999 16 days, and open day is on July 12nd, 2000, and publication number is CN1259382A) discloses a kind of Fructus Forsythiae Flos Lonicerae (liquid) electuary, its main prescription is: Flos Lonicerae 50g, Flos Chrysanthemi Indici 40g, Radix Glycyrrhizae 20g, Herba Taraxaci 50g, Radix Saposhnikoviae 15g, Herba Schizonepetae 20g, Rhizoma Typhonii 15g, Radix Trichosanthis 30g, Fructus Forsythiae 30g, Radix Angelicae Dahuricae 20g, Fructus Gardeniae 25g, Semen Coicis 30g, Radix Scutellariae 25g, Radix Et Rhizoma Rhei 10g, Cortex Dictamni 30g, Radix Rehmanniae 30g, Radix Angelicae Sinensis 20g, Gypsum Fibrosum 40g, Radix Platycodonis 20g, Cortex Moutan 30g, Radix Adenophorae (Radix Glehniae) 30g, Rhizoma Chuanxiong 25g, Radix Sophorae Flavescentis 10g, Radix Ophiopogonis 20g, Radix Isatidis 30g.
Its preparation method is may further comprise the steps:
Earlier with 24 flavor Chinese medicines such as Flos Lonicerae, Flos Chrysanthemi Indici, Radix Glycyrrhizae, Herba Taraxaci, Radix Saposhnikoviae, Herba Schizonepetae, Rhizoma Typhonii, Radix Trichosanthis, Fructus Forsythiae, the Radix Angelicae Dahuricae, Fructus Gardeniae, fry in shallow oil juice and get soup 400-450 milliliter, Radix Et Rhizoma Rhei is adopted the manufacture method of mongolian medicine again, grind superfine, crossing the 100-120 mesh sieve is powder.
The elite that its pure Chinese medicine is got in these No. 99126845.8 inventions, having changed medicine for external use can not eradicate, and has reached the effect of effecting a permanent cure, but also has weak point.Because wide in variety with medical material, materials are loaded down with trivial details, and only adopt in the preparation method of this electuary and decoct with water method and extract its effective ingredient, contained volatile oil component loss in a large number in extraction in its crude drug influences its drug effect, and utilization rate is low.
The experience prescription of the skin pruritus that medicine of the present invention is caused by damp and hot, wind heat, heat in blood according to clinical treatment has carried out systematic study, has developed " itch-stopping cicada formulation " of pure Chinese medicine.
Summary of the invention
Purpose of the present invention just is to work out a kind of itch-stopping cicada formulation, overcomes the deficiency of above-mentioned all kinds, does not contain chemical components and provide a kind of by pure Chinese medicine, does not contain hormone, has no side effect, and treating both the exterior and interior reaches the effect of better heat-clearing and toxic substances removing, dampness removing to stop itchin.This medicament can be prepared into different dosage form at needs of patients in addition, is convenient to take, and is easy to carry.
Another object of the present invention, work out the ten Six-element medical materials that utilize in this medicament exactly and be raw material, prepare the preparation method that function admirable meets the itch-stopping cicada formulation of Pharmacopoeia of the People's Republic of China standard, because Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine contain volatile oil component in the prescription, so extract the volatile oil of five tastes medical material earlier with the way of distillation, to carry most volatile oil degree of being, Aromatic water is continued to employ, and decocts with water with other drug again.Improve utilization ratio of raw materials greatly, more improved the drug effect of this medicine.
Volatile oil (volatile oils) claims quintessence oil (essential oils) again, be a class at normal temperatures can be evaporable, can with vapor distillation, with the general name of the immiscible oily liquids of water.Most of volatile oil have aromatic odor.Volatile oil have disperse induce sweat, effect such as causing resuscitation with aromatic drugs, regulating QI to relieve pain, expelling wind and removing dampness, blood circulation promoting and blood stasis dispelling, cold relieving warming the interior, heat-clearing and toxic substances removing, expelling summer-heat are dispelled dirty, insecticidal and antibacterial.
For achieving the above object, itch-stopping cicada formulation provided by the invention is formed by the following raw medicaments in portion by weight processing and preparing:
Flos Lonicerae 100-150 Fructus Gardeniae 100-150 Radix Scutellariae 100-150 Radix Sophorae Flavescentis 100-150
Cortex Phellodendri 75-110 Radix Gentianae 75-110 Radix Angelicae Dahuricae 100-150 Cortex Dictamni 100-150
Fructus Cnidii 100-150 Periostracum Cicadae 50-75 Fructus Forsythiae 100-150 Fructus Kochiae 100-150
Radix Rehmanniae 150-225 Herba Artemisiae Annuae 150-225 Herba Pogostemonis 100-150 Radix Glycyrrhizae 50-75
Preferred version is formed by the following raw medicaments in portion by weight processing and preparing:
Flos Lonicerae 110-135 Fructus Gardeniae 110-135 Radix Scutellariae 110-135 Radix Sophorae Flavescentis 110-135
Cortex Phellodendri 80-100 Radix Gentianae 80-100 Radix Angelicae Dahuricae 110-135 Cortex Dictamni 110-135
Fructus Cnidii 110-135 Periostracum Cicadae 55-70 Fructus Forsythiae 110-135 Fructus Kochiae 110-135
Radix Rehmanniae 170-205 Herba Artemisiae Annuae 170-205 Herba Pogostemonis 110-135 Radix Glycyrrhizae 55-70
Itch-stopping cicada formulation of the present invention can be prepared into granule, capsule, tablet, mixture.
Described weight portion can be weight metering units such as gram, two, jin, kilogram, ton.
Ten used Six-element medical materials are the Chinese crude drug that commercially available process is up to the standards.
The preparation method of itch-stopping cicada formulation comprises the steps:
(1) weight portion of each component is got raw material for standby;
(2) extract the volatile oil of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine with steam distillation, the aqueous solution after distillation device is in addition collected, and medicinal residues reclaim standby;
(3) medicinal residues of the Herba Pogostemonis after will distilling, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten simply the mixture of medical material decoct with water, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, being condensed into relative density is the clear paste of 1.10-1.30 (80 ℃), and it is dry to granulate with marumerization;
(4) volatile oil of the Herba Pogostemonis that adding extracts in granule, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae is good with 0.5ml, mixing, airtight 10-14 hour; Wherein to carry out seasoning be good to add Oleum menthae 0.3-0.6ml again.
The relative density of clear paste is 1.10-1.30 (80 ℃), is good with 1.20-1.22 (80 ℃) again.
Adopt marumerization to the clear paste drying of granulating.The concrete grammar of marumerization is, to spray-drying pelleting machine (PGL-80 type, drying equipment engineering company product of wide summer of Chongqing) adding adjuvant in is as bed material, the weight portion proportioning of clear paste and adjuvant is 1: 0.1-2.75, with 1: 1.7 was good, clear paste is as binding agent, make 20 orders-40 purpose granule, the control temperature of charge is controlled at 18-26Hz, air quantity at 0.15-0.18Mpa, spray speed at 55-60 ℃, atomizing pressure and makes granule be in fluidized state get final product, make granule mistake 10 orders and 60 mesh sieves respectively; Wherein the weight portion proportioning of adjuvant clear paste, sucrose, dextrin, stevioside, starch is 1: 0.7-0.9: 0.1-0.6: 0.1-0.45: 0.35-0.8.
Said steam distillation is, temperature is controlled at 100-120 ℃, under the normal pressure, get the mixture of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine, add the water that mixture 4-8 doubly measures, be distilled to till the no fragranced, the aqueous solution after the distillation is collected with the Pharmaceutical basin, and medicinal residues reclaim standby.
The condition that decocting boils is: decoct with water 2-4 time, the medicinal residues of each amount of water after for distillation and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten be 4-10 times of medical material mixture simply, each 1-5 hour, decocting temperature and be controlled at 80 ℃ to boiling, is good with 80 ℃.
The preparation method of granule is under the normal temperature and pressure, to get the mixture of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine, add the water that mixture 4-8 doubly measures, be distilled to till the no fragranced, the aqueous solution after the distillation is collected with the Pharmaceutical basin, and medicinal residues reclaim standby; With the Herba Pogostemonis after the distillation, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten is the mixture of medical material simply, decoct with water 2-4 time, each amount of water is the Herba Pogostemonis after distilling, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten simply the medical material mixture 4-10 doubly, each 1-5 hour, decoct temperature and be controlled at 80 ℃ to boiling, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and are concentrated into the clear paste of relative density 1.20～1.22 (80 ℃); With marumerization clear paste is carried out drying, in spray-drying pelleting machine, add the adjuvant clear paste, sucrose, dextrin, stevioside, at least a in the starch as bed material, clear paste is as binding agent, the weight portion proportioning of clear paste and adjuvant is 1: 0.1-2.75, make 20 orders-40 purpose granule, the control temperature of charge is at 55-60 ℃, atomizing pressure is at 0.15-0.18Mpa, spray speed is at 18-26Hz, air quantity is controlled at and makes granule be in fluidized state to get final product, make granule and cross 10 orders and 60 mesh sieves, wherein clear paste respectively, sucrose, dextrin, stevioside, the weight portion proportioning of starch is: 1: 0.7-0.9: 0.1-0.6: 0.1-0.45: 0.35-0.8; The volatile oil of the Herba Pogostemonis that adding extracts in granule, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.3-0.6ml again, mixing, and airtight 10-14 hour, for example make 1000g altogether, promptly get granule.
The preparation method of capsule is, is same as the preparation method of granule substantially, and having only different is to add the volatile oil of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae, mixing is ground into the 50-70 order, is good with 60 orders, dress up capsule, promptly get capsule, for example encapsulated 500.
The preparation method of tablet is, is same as the preparation method of granule substantially, has only different to be, adds the volatile oil of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae, mixing, and tabletting promptly gets tablet, for example is pressed into 500.
The preparation method of mixture is, is same as the preparation method of granule substantially, has only different to be, add the volatile oil of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae, add Oleum menthae 0.3-0.6ml and 3-10g sodium benzoate again, mixing, add water, promptly get mixture, for example add water to 1000ml.
Why the present invention selects for use above-mentioned medical material as raw material, is because they have following effect:
Flos Lonicerae: heat-clearing and toxic substances removing, control epidemic febrile disease heating, toxic-heat and blood stasis, carbuncle and ulcer, toxic swelling, scrofula
" the SHENGCAO property of medicine is wanted fully ": " energy eliminating carbuncle cellulitis furunculosis ... wash chancre, peeling skin heat in blood ".
" the southern regions of the Yunnan Province book on Chinese herbal medicine ": " all skin ulcers are separated in heat clearing away ... ".
Fructus Gardeniae: heat clearing away, pathogenic fire purging, removing heat from blood is controlled the calentura restlessness of asrhenia type and insomnia ... conjunctival congestion, dysentery, pathopyretic ulcer
" property of medicine opinion ": " parasite killing poison, the poison envelope of reducing phlegm and internal heat, sharp five types of stranguria, main attacked by pestiferous factors ... the disease heat extraction and the xerostomia of quenching one's thirst when controlling, conjunctival congestion and swelling pain "
" herbal classic ": " main pathogenic heat in the stomach gas, flushed complexion ... skin infection "
Radix Scutellariae: the removing the relative excess fire, except that damp and hot, control the high fever excessive thirst ... the carbuncle furuncle
" property of medicine opinion ": " control pyretic toxicity, alternate attack of chill and fever is separated wet thirsty ... "
" book on Chinese herbal medicine just ": " move back alternate attacks of chills and fever, wind heat is damp and hot, the heat of flesh table of dispelling especially is so control macule, skin infection "
Radix Sophorae Flavescentis: heat clearing away, dampness, eastern worm, control toxic-heat and blood stasis ... skin pruritus, mange malignant boil, erosion of vulva pruritus due to damp pathogen
" property of medicine opinion ": " control pyretic toxicity wind, the irritated skin ulcer of giving birth to of musculus cutaneus, red leprosy eyebrow takes off ....”
" the southern regions of the Yunnan Province book on Chinese herbal medicine ": " removing heat from blood, separate pyretic toxicity, mange, the impetigo poison is treated skin pruritus, and blood tinea corporis skin ulcer .. detumescence poison, expectorant are malicious ".
Cortex Phellodendri: dampness pathogenic fire purging, removing damp to relieve itching, heat-clearing and toxic substances removing
" not Lu ": " treat frightened gas between skin, red of skin heat, the hot swelling pain of order, aphtha.”
Radix Gentianae: eliminating pathogen in the liver gallbladder excess-fire, remove damp-heat in lower-JIAO, treating the liver is through intenseness of heat ... conjunctival congestion ... hematodiarrhoea, the carbuncle skin infection
" herbal classic ": " cold and heat between main bone ... kill diseases due to noxious agents produced by various parasites "
" the southern regions of the Yunnan Province book on Chinese herbal medicine ": " control and have sore throat, it is swollen to wash skin ulcer scabies poison.”
The Radix Angelicae Dahuricae: dispel the wind, dehumidifying, detumescence, pain relieving is controlled ... ulcer sores, skin pruritus due to dryness, scabies
" the southern regions of the Yunnan Province book on Chinese herbal medicine ": " wind of the skin migration of dispelling ends the cold pain of the cold stomachache of stomach, whole body cold-damp pain.”
" Japan hanako materia medica ": " control the conjunctival congestion bulbar conjunctiva polyp ... broken stagnated blood, mend fresh blood ... desolation, scabies, pain relieving granulation promoting ... "
Cortex Dictamni: dispel the wind, dampness, heat-clearing and toxic substances removing is controlled wind heat sore, scabies, itchy skin eruption, and rheumatism numbness is painful
" property of medicine opinion ": " controlling all pyretic toxicity wind, aversion to wind, wind skin ulcer ... "
" book on Chinese herbal medicine is original ": " controlling all mange, aversion to wind ... all skin ulcer pyretic toxicity "
Fructus Cnidii: dispel the wind dampness, parasite killing ... the dispelling the wind and dampness pathogens arthralgia pain, the scabies eczema
" property of medicine opinion ": " controlling arthralgia chiefly caused by damp pathogen, malicious wind, Persistent Pain ... go air-cooled ... main strong wind itching over the body ... "
Periostracum Cicadae: dispelling wind and heat pathogens ... control ... measles is sent out not smooth thoroughly, the rubella pruritus ... furuncle swelling toxin
" detailed outline ": " control ... skin rheumatism the cheating of bean rash ... and furuncle toxic swelling skin ulcer ....”
Itch-stopping cicada formulation provided by the invention has the effect of heat-clearing and toxic substances removing, dampness removing to stop itchin, the clinical papular urticaria that damp and hot interior aquatic weeds causes, the skin prurituss such as dermatitis aestivale of being used for.The detailed directions consumption of granule is that boiled water is taken after mixing it with water, a 16g, three times on the one, one after each meal; The detailed directions consumption of capsule, tablet, mixture is oral, and one time dose is equivalent to primary crude drug 30.7g, three times on the one, and one after each meal.
For the curative effect of itch-stopping cicada formulation is described, the applicant carries out pharmacodynamics test to it, and the result is as follows:
1. sedation experiment
1.1 influence to the pentobarbital sodium sub-threshold dose
Get the mice of body weight 18～22g, the male and female dual-purpose, divide four groups at random, drug component is not irritated stomach antipruritic 15 and 30g/kg, and positive controls is irritated stomach chlorpromazine 0.02g/kg, and matched group is given the distilled water of equivalent, after the administration 30 minutes, lumbar injection pentobarbital sodium 30mg/kg is sleeping index more than 1 minute with righting reflex loss, observes the sleep number of elements X that respectively organizes mice in 15 minutes
2Statistics.Antipruritic 30g/kg has significant sedation (P＜0.01) to mice as a result.The results are shown in Table 1.
Table 1 antipruritic is to the influence of pentobarbital sodium sub-threshold dose
| Group | Dosage (g/kg) | Number of animals (only) | Sleeping number of animals (only) |
| Matched group antipruritic antipruritic chlorpromazine | 15 30 0.02 | 10 10 10 9 | 1 4 *△△ 8** △ 9** |
Compare with matched group: * P＜0.05, * * P＜0.01
Compare with chlorpromazine:
△P＜0.05,
△ △P＜0.01
1.2 to the pentobarbital sodium influence of the length of one's sleep
Get the mice of body weight 18～20g, male and female half and half are divided into three groups at random, and drug component is not irritated stomach antipruritic 20,30g/kg, and matched group is irritated the distilled water of stomach equivalent, and after the administration 45 minutes, lumbar injection pentobarbital sodium 40mg/kg.With righting reflex loss with revert to index, observe the length of one's sleep of mice, with t primary system meter.Antipruritic 30g/kg can prolong pentobarbital sodium length of one's sleep very significantly as a result.The results are shown in Table 2.
Table 2 antipruritic is to the pentobarbital sodium influence of the length of one's sleep
| Group | Dosage (g/kg) | Number of animals (only) | The length of one's sleep (minute) |
| Matched group antipruritic antipruritic | 20 30 | 12 12 12 | 68.4±29.6 74.4±54.9 225.2±80.99 ** |
Compare with matched group: * P＜0.05, * * P＜0.01
2. antiallergic test
2.1 histamine is caused rat skin influence hypersensitive
Get the rat of body weight 150～200g, male and female half and half, divide five groups at random, drug component is not irritated stomach antipruritic 4,8,16g/kg, chlorphenamine 30mg/kg, matched group is given the equal-volume distilled water, every interval 12 hours once, totally 3 times, if the last administration is 50 minutes, respectively at the 100 μ g/ of unhairing district intradermal injection 0.1% 2 hydrochloric acid histamine of rat back, the 1% Yi Wensilan liquid 5mg/100g body weight of intravenous injection was immediately put to death rat after 30 minutes, cut the blue speckle skin in unhairing district, shred to be placed on and be with in the plug teat glass, use 6ml acetone: normal saline (7: 3) mixed liquid dipping 48 hours, take out the centrifugal back wavelength 590nm of leachate, 72 type tintometer colorimetrics, directly optical density (OD value) is carried out t primary system meter, and antipruritic 8 as a result, 16g/kg has tangible antagonism (P＜0.05, P＜0.01) to the skin allergy of rat due to the histamine.The results are shown in Table 3.
Table 3 antipruritic causes rat skin influence hypersensitive to histamine
| Group | Dosage (g/kg) | Number of animals (only) | OD value (g/kg) |
| Matched group antipruritic antipruritic antipruritic chlorpromazine | 4 8 16 0.03 | 10 10 10 10 10 | 0.495±0.108 0.432±0.109 △△△△ 0.373±0.10 *△△△ 0.346±0.118 **△△△ 0.123±0.086 ** |
Compare with matched group: * P＜0.05, * * P＜0.01
Compare with chlorphenamine:
△ △ △P＜0.01,
△ △ △ △P＜0.001
2.2 2,4 dinitrochlorobenzene (DNCB) are caused the influence of mice delayed hypersensitivity
Get the mice of body weight 18～20g, male and female half and half, be divided into four groups at random, drug component is not irritated stomach antipruritic 4,8g/kg, chlorphenamine 40mg/kg, matched group is given the equal-volume distilled water, and administration for the first time is after 24 hours, and every mouse back depilation district Intradermal only drips 6% DNCB acetone solution 0.03ml/, behind the successive administration 9 days, 6%DNCB Oleum Sesami liquid 0.03ml is applied to mouse right ear equably, puts to death mice after 16 hours, takes off left and right sides ear with the rustless steel punching pin and weighs, difference with the two is represented response strength, as a result, antipruritic 8g/kg can obviously weaken the delayed hypersensitivity of normal mouse.The results are shown in Table 4.
Table 4 couple DNCB causes the influence of mice delayed hypersensitivity
| Group | Dosage (g/kg) | Number of animals (only) | OD value (g/kg) |
| Matched group antipruritic antipruritic chlorphenamine | 4 8 0.05 | 10 10 10 9 | 3.7±2.06 2.7±3.08 △ 1.4±1.31 *△ 1.6±1.05 * |
Compare with matched group: * P＜0.05, compare with chlorphenamine:
△P＜0.05
3. antiinflammatory action test
3.1 xylol causes the influence of mice ear
Get the male mice of body weight 20～24g, be divided into four groups at random, drug component is not irritated stomach antipruritic 5,10,20g/kg, matched group is given the equal-volume distilled water, at interval 12 hours once, totally 5 times, after the last administration 50 minutes, evenly be coated with dimethylbenzene 0.03ml in mouse right ear, take off ears after 2 hours, take off auricle at corresponding site, weigh at precision torsion balance with the rustless steel boring of diameter 8mm, antipruritic 20g/kg can obviously alleviate mice caused by dimethylbenzene xylene ear swelling (P＜0.05) as a result, the results are shown in Table 5.
Table 5 xylol causes the influence of mice ear
| Group | Dosage (g/kg) | Number of animals (only) | Ears weight difference (mg) |
| Matched group antipruritic antipruritic antipruritic | 5 10 20 | 13 13 13 13 | 7.46±5.09 6.05±4.47 4.79±1.87 3.97±2.75 * |
Compare with matched group: * P＜0.05
3.2 on Carrageenan causes the influence (x ± SD) of mice foot swelling
Get the male mice of body weight 20～24g, be divided into five groups at random, drug component is not irritated stomach antipruritic 20,30,40g/kg, hydrocortisone 0.015g/kg, and matched group is given the equal-volume distilled water, at interval 12 hours once, totally 5 times, to cut biped and weigh retreating minister's undercoat intersection after 1 hour after the last administration, its biped weight difference is with t primary system meter, antipruritic 40g/kg can obviously alleviate the foot swelling (P＜0.05) that carrageenin causes mice as a result, the results are shown in Table 6.
Table 6 carrageenin causes the influence (x ± SD) of mice foot swelling
| Group | Dosage (g/kg) | Number of animals (only) | Ears weight difference (mg) |
| Matched group antipruritic antipruritic antipruritic hydrocortisone | 20 30 40 0.015 | 11 10 9 10 8 | 54.4±12.1 51.5±12.0 △ 50.8±12.6 △ 42.8±12.6 *△ 38.7±17.0 *△ |
Compare with matched group: * P＜0.05, compare with hydrocortisone
△P＞0.05
4. to the Detoxication of escherichia coli endotoxin
Get the mice of body weight 18～20g, male and female half and half are divided into four groups at random, drug component is not irritated stomach antipruritic 15,30g/kg, hydrocortisone 25mg/kg, and matched group is given the equal-volume distilled water, administration for the first time is after 12 hours, and totally 3 times, tail vein injection Escherichia coli O immediately after the last administration
111B
14Endotoxin 0.4ml (LD50 2 times) observes dead mouse number in 48 hours, uses X
2Check.Antipruritic 30g/kg can obviously reduce the mortality rate (P＜0.05) of animal in 24 hours behind counteracting toxic substances as a result, the results are shown in Table 7.
The Detoxication of table 7 pair escherichia coli endotoxin (x ± SD)
| Group | Dosage (g/kg) | Number of animals (only) | The ears weight difference | |
| 24 hours | 48 hours | |||
| Matched group antipruritic antipruritic hydrocortisone | 15 30 0.025 | 13 13 13 13 | 12 8 △△ 5 *△ 2 ** | 12 11 △△ 8 △△ 2 ** |
Compare with matched group: * P＜0.05,
*P＜0.01
Compare with hydrocortisone
△P＞0.05,
△ △P＜0.05
5. the external bacteriostasis test of antipruritic
5.1 adopt dull and stereotyped infiltration method.Adding antipruritic in the Carnis Bovis seu Bubali cream agar culture medium makes its concentration be respectively 1/50～1/1600.
Through 24 hours no varied bacteria growing persons of 37 ℃ of cultivations, behind 16 hours bacterial suspension inoculation of cultivation, put 37 ℃ and cultivated 24 hours, observe the growing state of each bacterium on the variable concentrations culture medium.Antipruritic concentration 1/300 can significantly suppress the growth of staphylococcus aureus as a result, and its concentration is can significantly suppress the growth of bacillus pyocyaneus, Bacillus proteus at 1/50 o'clock, and escherichia coli are not had obvious inhibitory action.The results are shown in Table 8.
Table 8 antipruritic is to the influence of bacterial growth
Annotate :-expression asepsis growth+expression is slightly grown
++ the growth of expression moderate +++expression riotous growth
5.2 antifungic action test: adopt test tube method, press the husky Ruo Shi of guarantor of document preparation culture medium.Drug level is 1/100,1/200,1/400, the matched group sterilized water, and each concentration is tee pipe.Every pipe heating is dissolved and is prepared into the inclined-plane, cultivates 24 hours for 37 ℃, and behind the no varied bacteria growing, inoculated fungi truffle one grain of rice size around 25～26 ℃ of cultivations, is observed the conk situation respectively.
Criterion: (-) conk is suppressed fully; (+) conk slightly suppressed or diameter less than 5mm; (++) conk is not suppressed, and bacterium colony size is similar to matched group or greater than 5mm.As a result, antipruritic 1/100,1/200,1/400 concentration is to trichophyton gypseum, and trichophyton, trichophyton and trichophyton all have inhibitory action.The results are shown in Table 9.
Table 9 antipruritic is to the influence of conk
| Bacterial strain | Matched group | Antipruritic concentration | ||
| 1/100 | 1/200 | 1/400 | ||
| Trichophyton gypseum trichophyton trichophyton trichophyton | (++) (++) (++) (++) | (-) (-) (-) (-) | (-) (-) (-) (-) | (-) (-) (-) (-) |
This result of the test shows: itch-stopping cicada formulation can obviously prolong the length of one's sleep of pentobarbital sodium to mice, with subliminal hypnosis dosage pentobarbital sodium synergism is arranged; Mice ear due to the xylol and the foot swelling of carrageenin induced mice have significant inhibitory effect; Rat skin anaphylaxis due to the histamine there is significant antagonism, and can obviously weakens the delayed hypersensitivity that DNCB causes; Can prolong Escherichia coli and bacillus pyocyaneus O
111B
4The death time of endotoxin induced mice; Experiment in vitro is to antibacterial and trichophyton gypseums such as staphylococcus aureus, Bacillus proteus and bacillus pyocyaneus, and trichophyton, trichophyton and trichophyton all have inhibitory action.
In order further to estimate the clinical effectiveness of itch-stopping cicada formulation, investigate the safety of clinical use, according to unified clinical observation scheme to itch-stopping cicada formulation treat acute urticaria, papular urticaria, genus wind heat, heat in blood, damp and hot summer dermatitis card has carried out clinical verification, and compare observation with up-to-date second filial generation antihistaminic hismanal, existing the result is reported as follows:
1. clinical data:
1.1 physical data: this checking, observe case 253 examples altogether, wherein male 96 examples, women 157 examples, 0～9 years old 37 age example, 10～19 years old 25 example, 20～29 years old 50 example, 30～39 years old 46 example, 40～49 years old 29 examples, 50～59 years old 31 example, 60～69 years old 28 example, 7 examples more than 70 years old.In minimum January, maximum 81 years old, person below 30 years old accounted for 44.26%.
1.2 case is selected: be diagnosed as acute urticaria according to high medical college medical material " skin science ", papular urticaria, summer dermatitis, and by high medical college teaching material " Surgery of Chinese Medicine " dialectical be wind heat, heat in blood, damp and hot pattern of syndrome, no hyperpyrexia, the laryngeal edema, collapse and infection sepage person include observation in.In respect of acute urticaria 89 examples, papular urticaria 51 examples, summer dermatitis 90 examples, 23 examples such as eczema.Wherein dialectical is anemopyretic 133 examples, blood-heat type 50 examples, damp-heat type 70 examples, 12 examples that the state of an illness is slight, moderate 129 examples, severe 112 examples, in, severe accounts for 95.2%.
2. verification method
2.1, will include the observation case in by table of random number and be divided into treatment group and matched group according to randomly assigne.160 examples are organized in treatment, matched group 93 examples, and two groups are unanimous on the whole on sex, age, sick kind and severe extent.
2.2 Therapeutic Method
The treatment group is used medicine of the present invention (itch-stopping cicada granule), each 16 grams of being grown up, day clothes 3 times; The children's dress adult measures below 1/2,6 years old the clothes adult to measure 1/4,4 is a course of treatment more than 6 years old, obeys 2 courses of treatment altogether.
The hismanal that matched group adopts commercially available Xi'an Yang Sen company to produce, the adult obey every day one time 10 milligrams, taking medicine before meal early.Take by 0.2 milligram/kg body weight/day below 6 years old.The course of treatment same itch-stopping cicada formulation.
Two groups of outer putting on the skin of the placebo " antipruritic application agent " that all uses normal saline to add Fructus Citri Limoniae food coloring to make.
2.3 detailed medical history-taking before all case observations, health check-up, by unified charting case history are looked into the total classification of Bai and oxyphil cell's numeration.Finish for the 1st course of treatment by the rank scores record state of an illness once to finish for the 2nd course of treatment to check and judge curative effect.
3. checking result
3.1 curative effect judging standard:
Recovery from illness: gargalesthesia disappears, and erythra disappears fully;
Produce effects: gargalesthesia obviously alleviates, and deflorescence is more than 60%;
Effectively: gargalesthesia alleviates, deflorescence 20%～60%;
Invalid: gargalesthesia ditto or more acute, deflorescence less than 20% or increase the weight of.
3.2 therapeutic outcome
3.2.1 160 examples are organized in treatment, total effective rate 94.99%, obvious effective rate 78.74%, matched group 93 examples, total effective rate 82.78%, obvious effective rate 75.26%.Learn by statistics and handle the two obvious effective rate there was no significant difference (P＞0.01).See Table 1.
Table 1 treatment group and matched group clinical efficacy are relatively
| Group | The example number | Recovery from illness (%) | Produce effects (%) | Effectively (96) | Invalid (%) | Obvious effective rate (%) | Recovery from illness (%) |
| Matched group | 160 | 99(61.87) | 27(16.87) | 26(16.27) | 8(5.00) | 78.74 | 94.99 |
| Matched group | 93 | 61(65.59) | 9(9.67) | 7(7.52) | 16(17.00) | 75.26 | 82.78 |
3.2.2 treatment group acute urticaria, papular urticaria, the sick total effective rate of planting of summer dermatitis are excellent all more than 90% than matched group, but matched group is high than the treatment group on urticarial obvious effective rate.See Table 2.
| The sick kind | Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Obvious effective rate (%) | Total effective rate (%) |
| Anxious nettle mound nettle | Treatment contrast treatment contrast treatment | 45 44 34 17 65 | 33 36 25 14 35 | 2 2 7 2 15 | 7 1 1 0 12 | 3 5 1 1 3 | 77.78 86.36 94.12 94.12 76.92 | 93.33 88.63 97.06 94.12 95.38 |
| Summer skin eczema | Contrast treatment contrast | 25 16 7 | 11 6 0 | 2 3 3 | 5 6 1 | 7 1 3 | 52.00 56.25 42.85 | 72.00 93.75 57.14 |
3.2.3 treatment group wind heat, heat in blood, damp and hot three card total effective rates are also all more than 90%, wherein wind heat, heat in blood two card treatment groups are better than matched group, and damp and hot pattern of syndrome then is that matched group total effective rate and obvious effective rate all are height than the treatment group.See Table 3.
| The sick kind | Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Obvious effective rate (%) | Total effective rate (%) |
| The damp and hot summer skin of wind heat | The contrast for the treatment of randomized controlled treatment randomized controlled treatment | 76 57 32 18 52 18 | 50 41 18 8 31 12 | 13 4 6 1 8 4 | 11 5 7 1 8 1 | 2 7 1 8 5 1 | 82.89 78.94 75.00 50.00 75.00 88.88 | 97.36 97.71 96.87 55.55 90.38 94.44 |
3.2.4 treatment group recovery from illness case, 1/3rd in first course of treatment, and 2/3rds in second course of treatment, and onset and cure time are slow than matched group.See Table 4.
Table 4 therapeutic effect and the course of treatment relation
| Group | The routine number of fully recovering | One course of treatment example number (%) | Two courses of treatment examples number (%) | Three courses of treatment examples number (%) |
| Treatment group matched group | 99 61 | 30(30.30) 29(47.54) | 68(68.68) 31(50.81) | 1(1.01) 1(1.63) |
3.2.5 160 examples are organized in treatment, and side effect person's 9 examples take place, and account for 5.62%, matched group 93 examples are not found apparent side effect.The side effect of treatment group concentrates in the intestines and stomach reaction, in respect of xerostomia 2 examples, and appetite 1 example that descends, stomach upset 2 examples of feeling sick are vomitted 1 example, 1 example of suffering from diarrhoea, dizzy 2 examples.How not serious these side effect are, alleviates dose or drug withdrawal disappears immediately.
4. conclusion
4.1 itch-stopping cicada formulation belongs to wind heat, heat in blood, damp and hot person to acute urticaria, papular urticaria, summer dermatitis card, curative effect affirms that obvious effective rate reaches 78.84%, with up-to-date second filial generation antihistaminic hismanal basically identical, (hismanal obvious effective rate 75.26%, P＞0.1).Total effective rate then itch-stopping cicada formulation is higher than hismanal, P＜0.01, and difference has the significance meaning.
4.2 from clinical effectiveness, itch-stopping cicada dosage that granule is decided is suitable, taking convenience, and the required time of only fully recovering is longer, answers Xiang doctor and patient and does certain explanation, makes it to adhere to medication, guarantees curative effect.
4.3 the itch-stopping cicada formulation side effect is slight, taking convenience.Because of there being bitter colds such as Radix Sophorae Flavescentis to cut down the product of stomach in its prescription, can cause vomiting to feel sick, so the suitable careful usefulness of baby.
4.4 in sum, the itch-stopping cicada formulation prescription rationally, and is superior in quality, and good effect is safe and simple.
The excellent results of itch-stopping cicada formulation of the present invention and preparation method thereof just is:
1. medicament of the present invention is made by pure Chinese medicine, does not contain chemical components, does not contain hormone, has no side effect, and treating both the exterior and interior reaches the effect of better heat-clearing and toxic substances removing, dampness removing to stop itchin.
2. this medicament can be prepared into different dosage form at needs of patients, is convenient to take, and is easy to carry.
3. the volatile oil of five tastes medical materials such as process using way of distillation extraction Herba Pogostemonis of the present invention has improved utilization ratio of raw materials greatly, has more improved the drug effect of this medicine.
The specific embodiment
Below with embodiment itch-stopping cicada formulation of the present invention and preparation method thereof is further described, this will help the present invention and effect thereof are further understood, embodiment does not limit protection scope of the present invention, its protection domain is decided by claim.
Embodiment 1
Used crude drug is Flos Lonicerae 100g, Fructus Gardeniae 100g, Radix Scutellariae 110g, Radix Sophorae Flavescentis 110g, Cortex Phellodendri 75g, Radix Gentianae 75g, Radix Angelicae Dahuricae 100g, Cortex Dictamni 100g, Fructus Cnidii 100g, Periostracum Cicadae 62g, Fructus Forsythiae 110g, Fructus Kochiae 110g, Radix Rehmanniae 190g, Herba Artemisiae Annuae 186g, Herba Pogostemonis 110g, Radix Glycyrrhizae 50g in the present embodiment.
Its preparation method is:
(1) gets Herba Pogostemonis 110g, Flos Lonicerae 100g, Fructus Forsythiae 110g, Radix Angelicae Dahuricae 100g, Herba Artemisiae Annuae 186g;
(2) get the mixture of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine with steam distillation, add the water of 6 times of amounts of mixture, be distilled to till the no fragranced, the aqueous solution after the distillation is collected with the Pharmaceutical basin, medicinal residues reclaim standby, and temperature is 100 ℃, normal pressure;
(3) Herba Pogostemonis after will distilling, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 8 times of mixture decocted 1 hour, for the second time amount of water is that 6 times of mixture decocted 1 hour, amount of water is 5 times of mixture and decocted 0.5 hour for the third time, decoct temperature and be controlled at 80 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, and being condensed into relative density is the clear paste of 1.20 (80 ℃); With marumerization clear paste is carried out drying, add adjuvant sucrose, dextrin, stevioside, starch as bed material to spray-drying pelleting machine, clear paste is as binding agent, the weight portion proportioning of clear paste and adjuvant is 1: 2.15, make 20 purpose granules, the control temperature of charge is that 55 ℃, atomizing pressure are that 0.15Mpa, spray speed are controlled at 18Hz, air quantity and make granule be in fluidized state, makes granule and crosses 10 orders and 60 mesh sieves respectively; Wherein the weight portion proportioning of clear paste, sucrose, dextrin, stevioside, starch is 1: 0.8: 0.5: 0.45: 0.4;
(4) volatile oil of the Herba Pogostemonis that adding extracts in granule, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.5ml again, and mixing airtight 12 hours, makes granule.
Embodiment 2
Used process equipment and raw material are substantially with embodiment 1, and only different is not add Oleum menthae.
Embodiment 3
Used process equipment and raw material be substantially with embodiment 1, and only different is with Flos Lonicerae 110g, Fructus Gardeniae 110g, Radix Scutellariae 120g, Radix Sophorae Flavescentis 120g, Cortex Phellodendri 90g, Radix Gentianae 90g, Radix Angelicae Dahuricae 110g, Cortex Dictamni 110g, Fructus Cnidii 110g, Periostracum Cicadae 50g, Fructus Forsythiae 140g, Fructus Kochiae 140g, Radix Rehmanniae 150g, Herba Artemisiae Annuae 150g, Herba Pogostemonis 124g, Radix Glycyrrhizae 70g is raw material.
Embodiment 4
Used process equipment and raw material are substantially with embodiment 1, only different is with medicinal residues and Fructus Gardeniae after the distillation, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 10 times of mixture decocted 2 hours, for the second time amount of water is that 8 times of mixture decocted 1 hour, amount of water is 6 times of mixture and decocted 1 hour for the third time, decoct temperature and be controlled at 90 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, being condensed into relative density is the clear paste of 1.30 (80 ℃), add adjuvant sucrose, dextrin, stevioside, wherein clear paste, sucrose, dextrin, the weight portion proportioning of stevioside is 1: 0.7: 0.4: 0.35.
Embodiment 5
Used process equipment and raw material are substantially with embodiment 1, only different is with the medicinal residues after the distillation and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten simply the medical material mixture decoct with water 2 times, for the first time amount of water is that 8 times of mixture decocted 2 hours, for the second time amount of water is that 6 times of mixture decocted 1 hour, add adjuvant sucrose, dextrin, wherein the weight portion proportioning of clear paste, sucrose, dextrin is 1: 0.9: 0.6.
Embodiment 6
Used process equipment and raw material are substantially with embodiment 1, and only different is to add the adjuvant dextrin as bed material to spray-drying pelleting machine, and clear paste is as binding agent, and wherein the weight portion proportioning of clear paste, sucrose is 1: 0.85.
Embodiment 7
Used crude drug is Flos Lonicerae 120g, Fructus Gardeniae 120g, Radix Scutellariae 100g, Radix Sophorae Flavescentis 100g, Cortex Phellodendri 80g, Radix Gentianae 80g, Radix Angelicae Dahuricae 124g, Cortex Dictamni 120g, Fructus Cnidii 120g, Periostracum Cicadae 75g, Fructus Forsythiae 100g, Fructus Kochiae 100g, Radix Rehmanniae 170g, Herba Artemisiae Annuae 170g, Herba Pogostemonis 100g, Radix Glycyrrhizae 62g in the present embodiment.
Its preparation method is:
(1) gets Herba Pogostemonis 100g, Flos Lonicerae 120g, Fructus Forsythiae 100g, Radix Angelicae Dahuricae 124g, Herba Artemisiae Annuae 170g;
(2) get the mixture of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine with steam distillation, add the water of 4 times of amounts of mixture, be distilled to till the no fragranced, the aqueous solution after the distillation is collected with the Pharmaceutical basin, medicinal residues reclaim standby, and temperature is 110 ℃, normal pressure;
(3) Herba Pogostemonis after will distilling, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 8 times of mixture decocted 2 hours, for the second time amount of water is that 6 times of mixture decocted 1 hour, amount of water is 4 times of mixture and decocted 1 hour for the third time, decoct temperature and be controlled at 80 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, and being condensed into relative density is the clear paste of 1.22 (80 ℃); With marumerization clear paste is carried out drying, add adjuvant clear paste, sucrose, dextrin, stevioside, starch as bed material to spray-drying pelleting machine, clear paste is as binding agent, the weight portion proportioning of clear paste and adjuvant is 1: 1.61, make 30 purpose granules, the control temperature of charge is that 60 ℃, atomizing pressure are that 0.17Mpa, spray speed are controlled at 23Hz, air quantity and make granule be in fluidized state, makes granule and crosses 10 orders and 60 mesh sieves respectively; Wherein the weight portion proportioning of clear paste, sucrose, dextrin, stevioside, starch is 1: 1: 0.81: 0.2: 0.1: 0.5.
(4) volatile oil of the Herba Pogostemonis that adding extracts in granule, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.4ml again, mixing, and airtight 11 hours, be ground into 60 orders, incapsulate 500, make capsule.
Embodiment 8
Used process equipment and raw material are substantially with embodiment 7, and only different is not add Oleum menthae.
Embodiment 9
Used process equipment and raw material be substantially with embodiment 7, and only different is with Flos Lonicerae 124g, Fructus Gardeniae 140g, Radix Scutellariae 140g, Radix Sophorae Flavescentis 150g, Cortex Phellodendri 93g, Radix Gentianae 100g, Radix Angelicae Dahuricae 140g, Cortex Dictamni 130g, Fructus Cnidii 130g, Periostracum Cicadae 70g, Fructus Forsythiae 124g, Fructus Kochiae 124g, Radix Rehmanniae 186g, Herba Artemisiae Annuae 190g, Herba Pogostemonis 140g, Radix Glycyrrhizae 75g is raw material.
Embodiment 9
Used process equipment and raw material are substantially with embodiment 7, only different is with medicinal residues and Fructus Gardeniae after the distillation, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 8 times of mixture decocted 2 hours, for the second time amount of water is that 6 times of mixture decocted 1 hour, amount of water is 4 times of mixture and decocted 0.5 hour for the third time, decoct temperature and be controlled at 90 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, being condensed into relative density is the clear paste of 1.10 (80 ℃), add adjuvant sucrose, dextrin, stevioside, wherein clear paste, sucrose, dextrin, the weight portion proportioning of stevioside is 1: 0.9: 0.3: 0.1; The volatile oil of the Herba Pogostemonis that adding extracts in granule, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.5ml again, and mixing airtight 12 hours, is ground into 70 orders.
Embodiment 10
Used process equipment and raw material are substantially with embodiment 7, only different is with medicinal residues and Fructus Gardeniae after the distillation, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 4 times, for the first time amount of water is that 10 times of mixture decocted 2 hours, for the second time amount of water is that 8 times of mixture decocted 1 hour, amount of water is 6 times of mixture and decocted 1 hour for the third time, the 4th amount of water is that 4 times of mixture decocted 0.5 hour, add the adjuvant dextrin, starch, wherein clear paste, dextrin, the weight portion proportioning of starch is 1: 0.2: 0.35; Be ground into 50 orders.
Embodiment 11
Used process equipment and raw material are substantially with embodiment 7, and only different is to add the adjuvant dextrin as bed material to spray-drying pelleting machine, and clear paste is as binding agent, and wherein the weight portion proportioning of clear paste, dextrin is 1: 0.1.
Embodiment 12
Used crude drug is Flos Lonicerae 130g, Fructus Gardeniae 124g, Radix Scutellariae 130g, Radix Sophorae Flavescentis 140g, Cortex Phellodendri 110g, Radix Gentianae 110g, Radix Angelicae Dahuricae 130g, Cortex Dictamni 140g, Fructus Cnidii 150g, Periostracum Cicadae 55g, Fructus Forsythiae 120g, Fructus Kochiae 120g, Radix Rehmanniae 200g, Herba Artemisiae Annuae 200g, Herba Pogostemonis 120g, Radix Glycyrrhizae 60g in the present embodiment.
Its preparation method is:
(1) gets Herba Pogostemonis 120g, Flos Lonicerae 130g, Fructus Forsythiae 120g, Radix Angelicae Dahuricae 130g, Herba Artemisiae Annuae 200g;
(2) get the mixture of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine with steam distillation, add the water of 8 times of amounts of mixture, be distilled to till the no fragranced, the aqueous solution after the distillation is collected with the Pharmaceutical basin, medicinal residues reclaim standby, and temperature is 120 ℃, normal pressure;
(3) Herba Pogostemonis after will distilling, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 8 times of mixture decocted 2.5 hours, for the second time amount of water is that 6 times of mixture decocted 1 hour, amount of water is 5 times of mixture and decocted 0.5 hour for the third time, decoct temperature and be controlled at 90 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, and being condensed into relative density is the clear paste of 1.22 (80 ℃); With marumerization to the clear paste drying of granulating, add the mixture of adjuvant sucrose, dextrin, stevioside, starch as bed material to spray-drying pelleting machine, clear paste is as binding agent, the weight portion proportioning of clear paste and adjuvant is 1: 1.7, make 40 purpose granules, the control temperature of charge is that 55 ℃, atomizing pressure are that 0.16Mpa, spray speed are controlled at 20Hz, air quantity and make granule be in fluidized state, makes granule and crosses 10 orders and 60 mesh sieves respectively; Wherein the weight portion proportioning of clear paste, sucrose, dextrin, stevioside, starch is 1: 0.7: 0.3: 0.35: 0.35.
(4) add the volatile oil of the Herba Pogostemonis extract, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae, add Oleum menthae 0.3ml again, mixing, airtight 10 hours, mixing, tabletting promptly gets tablet.
Embodiment 13
Used process equipment and raw material are substantially with embodiment 12, and only different is not add Oleum menthae.
Embodiment 14
Used process equipment and raw material be substantially with embodiment 12, and only different is with Flos Lonicerae 140g, Fructus Gardeniae 130g, Radix Scutellariae 150g, Radix Sophorae Flavescentis 130g, Cortex Phellodendri 85g, Radix Gentianae 93g, Radix Angelicae Dahuricae 120g, Cortex Dictamni 120g, Fructus Cnidii 140g, Periostracum Cicadae 65g, Fructus Forsythiae 150g, Fructus Kochiae 130g, Radix Rehmanniae 210g, Herba Artemisiae Annuae 210g, Herba Pogostemonis 150g, Radix Glycyrrhizae 55g is raw material.
Embodiment 15
Used process equipment and raw material are substantially with embodiment 12, only different is with the Herba Pogostemonis after the distillation, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 8 times of mixture decocted 2 hours, for the second time amount of water is that 6 times of mixture decocted 1 hour, amount of water is 4 times of mixture and decocted 0.5 hour for the third time, decoct temperature and be controlled at 90 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, being condensed into relative density is the clear paste of 1.15 (80 ℃), add adjuvant sucrose, dextrin, starch, wherein clear paste, sucrose, dextrin, the weight portion proportioning of starch is 1: 0.7: 0.2: 0.6; The volatile oil of the Herba Pogostemonis that adding extracts, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.5ml, mixing, airtight 13 hours again.
Embodiment 16
Used process equipment and raw material are substantially with embodiment 12, only different is with medicinal residues and Fructus Gardeniae after the distillation, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 4 times, for the first time amount of water is that 10 times of mixture decocted 2 hours, for the second time amount of water is that 8 times of mixture decocted 1 hour, amount of water is 6 times of mixture and decocted 1 hour for the third time, the 4th amount of water is that 4 times of mixture decocted 0.5 hour, add adjuvant sucrose, starch, wherein clear paste, sucrose, the weight portion proportioning of starch is 1: 0.7: 0.35.
Embodiment 17
Used process equipment and raw material are substantially with embodiment 12, and only different is to add the adjuvant stevioside as bed material to spray-drying pelleting machine, and clear paste is as binding agent, and wherein the weight portion proportioning of clear paste, stevioside is 1: 0.45.
Embodiment 18
Used crude drug is Flos Lonicerae 150g, Fructus Gardeniae 150g, Radix Scutellariae 124g, Radix Sophorae Flavescentis 124g, Cortex Phellodendri 100g, Radix Gentianae 85g, Radix Angelicae Dahuricae 150g, Cortex Dictamni 150g, Fructus Cnidii 124g, Periostracum Cicadae 60g, Fructus Forsythiae 130g, Fructus Kochiae 150g, Radix Rehmanniae 225g, Herba Artemisiae Annuae 225g, Herba Pogostemonis 130g, Radix Glycyrrhizae 65g in the present embodiment.
Its preparation method is:
(1) gets Herba Pogostemonis 130g, Flos Lonicerae 150g, Fructus Forsythiae 130g, Radix Angelicae Dahuricae 150g, Herba Artemisiae Annuae 225g;
(2) get the mixture of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine with steam distillation, add the water of 8 times of amounts of mixture, be distilled to till the no fragranced, the aqueous solution after the distillation is collected with the Pharmaceutical basin, medicinal residues reclaim standby, and temperature is 110 ℃, normal pressure;
(3) Herba Pogostemonis after will distilling, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 10 times of mixture decocted 2.5 hours, for the second time amount of water is that 8 times of mixture decocted 1 hour, amount of water is 5 times of mixture and decocted 1 hour for the third time, decoct temperature and be controlled at 90 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, and being condensed into relative density is the clear paste of 1.22 (80 ℃); With marumerization to the clear paste drying of granulating, add the mixture of adjuvant sucrose, dextrin, stevioside, starch as bed material to spray-drying pelleting machine, clear paste is as binding agent, the weight portion proportioning of clear paste and adjuvant is 1: 2.75, make 40 purpose granules, the control temperature of charge is that 60 ℃, atomizing pressure are that 0.18Mpa, spray speed are controlled at 26Hz, air quantity and make granule be in fluidized state, makes granule and crosses 10 orders and 60 mesh sieves respectively; Wherein the weight portion proportioning of clear paste, sucrose, dextrin, stevioside, starch is 1: 0.9: 0.6: 0.45: 0.8.
(4) add the volatile oil of the Herba Pogostemonis extract, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae, add Oleum menthae 0.6 and 3g sodium benzoate again, mixing adds water to 1000ml, promptly gets mixture.
Embodiment 19
Used process equipment and raw material are substantially with embodiment 18, and only different is not add Oleum menthae.
Embodiment 20
Used process equipment and raw material be substantially with embodiment 18, and only different is with Flos Lonicerae 136g, Fructus Gardeniae 136g, Radix Scutellariae 143g, Radix Sophorae Flavescentis 143g, Cortex Phellodendri 106g, Radix Gentianae 106g, Radix Angelicae Dahuricae 136g, Cortex Dictamni 136g, Fructus Cnidii 143g, Periostracum Cicadae 70g, Fructus Forsythiae 136g, Fructus Kochiae 136g, Radix Rehmanniae 206g, Herba Artemisiae Annuae 210g, Herba Pogostemonis 143g, Radix Glycyrrhizae 70g is raw material.
Embodiment 21
Used process equipment and feedstock composition are substantially with embodiment 18, only different is with the Herba Pogostemonis after the distillation, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae medicinal residues and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten medical material mixture simply decocts with water 3 times, for the first time amount of water is that 8 times of mixture decocted 2 hours, for the second time amount of water is that 6 times of mixture decocted 1 hour, amount of water is 4 times of mixture and decocted 0.5 hour for the third time, decoct temperature and be controlled at 80 ℃, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, being condensed into relative density is the clear paste of 1.15 (80 ℃), add the adjuvant dextrin, stevioside, starch, wherein clear paste, dextrin, stevioside, the weight portion proportioning of starch is 1: 0.1: 0.2: 0.7; The volatile oil of the Herba Pogostemonis that adding extracts, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.5 and 10g sodium benzoate again.
Embodiment 22
Used process equipment and feedstock composition are substantially with embodiment 18, only different is with the medicinal residues after the distillation and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten simply the medical material mixture decoct with water 2 times, for the first time amount of water is that 8 times of mixture decocted 2.5 hours, for the second time amount of water is that 5 times of mixture decocted 1 hour, add adjuvant stevioside, starch, wherein the weight portion proportioning of clear paste, stevioside, starch is 1: 0.35: 0.4; The volatile oil of the Herba Pogostemonis that adding extracts, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.4 and 6g sodium benzoate again.
Embodiment 23
Used process equipment and raw material are substantially with embodiment 18, and only different is to add the adjuvant dextrin as bed material to spray-drying pelleting machine, and clear paste is as binding agent, and wherein the weight portion proportioning of clear paste, starch is 1: 0.35.
Claims (10)
1, a kind of itch-stopping cicada formulation is characterized in that being formed by the following raw medicaments in portion by weight processing and preparing:
Flos Lonicerae 100-150 Fructus Gardeniae 100-150 Radix Scutellariae 100-150 Radix Sophorae Flavescentis 100-150
Cortex Phellodendri 75-110 Radix Gentianae 75-110 Radix Angelicae Dahuricae 100-150 Cortex Dictamni 100-150
Fructus Cnidii 100-150 Periostracum Cicadae 50-75 Fructus Forsythiae 100-150 Fructus Kochiae 100-150
Radix Rehmanniae 150-225 Herba Artemisiae Annuae 150-225 Herba Pogostemonis 100-150 Radix Glycyrrhizae 50-75.
2,, it is characterized in that forming by the following raw medicaments in portion by weight processing and preparing according to the itch-stopping cicada formulation of claim 1:
Flos Lonicerae 110-135 Fructus Gardeniae 110-135 Radix Scutellariae 110-135 Radix Sophorae Flavescentis 110-135
Cortex Phellodendri 80-100 Radix Gentianae 80-100 Radix Angelicae Dahuricae 110-135 Cortex Dictamni 110-135
Fructus Cnidii 110-135 Periostracum Cicadae 55-70 Fructus Forsythiae 110-135 Fructus Kochiae 110-135
Radix Rehmanniae 170-205 Herba Artemisiae Annuae 170-205 Herba Pogostemonis 110-135 Radix Glycyrrhizae 55-70.
According to the itch-stopping cicada formulation of claim 1, it is characterized in that 3, preparation is granule, capsule, tablet, mixture.
4, according to the preparation method of claim 1,2 one of them described itch-stopping cicada formulation, it is characterized in that comprising the steps:
(1) gets raw material for standby by the weight portion of each component;
(2) extract the volatile oil of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine with steam distillation, the aqueous solution after distillation device is in addition collected, and medicinal residues reclaim standby;
(3) medicinal residues of the Herba Pogostemonis after will distilling, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten simply the mixture of medical material decoct with water, collecting decoction, filter, aqueous solution after filtrate and the distillation merges, being condensed into relative density is the clear paste of 1.10-1.30 (80 ℃), makes granule, drying with marumerization;
(4) volatile oil of the Herba Pogostemonis that adding extracts in granule, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae, mixing, airtight 10-14 hour.
5, according to the preparation method of the itch-stopping cicada formulation of claim 4, it is characterized in that, the volatile oil of the Herba Pogostemonis that adding extracts in the granule that marumerization is made, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae adds Oleum menthae 0.3-0.6ml again and carries out seasoning.
6, according to the preparation method of the itch-stopping cicada formulation of claim 4, it is characterized in that, the condition that decocting boils is: decoct with water 2-4 time, the medicinal residues of each amount of water after for distillation and Fructus Gardeniae, Radix Scutellariae, Radix Sophorae Flavescentis, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Fructus Cnidii, Periostracum Cicadae, the Fructus Kochiae, Radix Rehmanniae, Radix Glycyrrhizae ten be 4-10 times of medical material mixture simply, each 0.5-2.5 hour, decoct temperature and be controlled at 80 ℃ to boiling.
7, according to the preparation method of the itch-stopping cicada formulation of claim 4, it is characterized in that, adopt marumerization the clear paste drying of granulating.Marumerization is, in used container, add adjuvant and be at least a in sucrose, dextrin, stevioside, the starch as bed material, clear paste is as binding agent, the weight portion proportioning of clear paste and adjuvant is 1: 0.1-2.75, make 20 orders-40 purpose granule, the control temperature of charge is controlled at 18-26Hz, air quantity at 0.15-0.18Mpa, spray speed at 55-60 ℃, atomizing pressure and makes granule be in fluidized state get final product, make granule mistake 10 orders and 60 mesh sieves respectively.
8, according to the preparation method of the itch-stopping cicada formulation of claim 6, it is characterized in that, adjuvant is the mixture of sucrose, dextrin, stevioside, starch, and the weight portion proportioning of clear paste, sucrose, dextrin, stevioside, starch is 1: 0.7-0.9: 0.1-0.6: 0.1-0.45: 0.35-0.8.
9, according to the preparation method of the itch-stopping cicada formulation of claim 4, it is characterized in that, said steam distillation is, temperature is controlled at 100-120 ℃, under the normal pressure, get the mixture of Herba Pogostemonis, Flos Lonicerae, Fructus Forsythiae, the Radix Angelicae Dahuricae, Herba Artemisiae Annuae five kinds of Chinese medicine, add the water that mixture 4-8 doubly measures, aqueous solution after distillation device is in addition collected, and medicinal residues reclaim standby.
10, according to the preparation method of the itch-stopping cicada formulation of claim 4, it is characterized in that the relative density of clear paste is 1.20-1.22 (80 ℃).
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