CN1682856A - Medicine composition for treating skin itching and senile skin itching and its preparing method - Google Patents
Medicine composition for treating skin itching and senile skin itching and its preparing method Download PDFInfo
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Abstract
The medicine composition for treating skin itching including senile skin itching is prepared with prepared fleeceflower root, white peony root, tree peony bark, earthworm, buffalo horn and other seven kinds of Chinese medicinal materials. The preparation process includes grinding partial material, alcohol extracting partial material, water extracting partial material, concentrating, distilling partial material, beta-CD including to obtain beta-CD inclusion, adding conventional supplementary material, and forming conventional oral preparation. The present invention is used to treat skin itching including senile skin itching.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of skin pruritus and senile skin pruritus and preparation method thereof, be specially pharmaceutical composition that contains Chinese medicine extract and preparation method thereof.
Background technology
Skin pruritus is one of a kind of dermatology common disease that does not have primary cutaneous infringement with skin pruritus, frequently-occurring disease.Scope according to skin pruritus is divided into general (general property) skin pruritus and limitation skin pruritus clinically.The general skin pruritus is modal to surely belong to the Secondary cases skin pruritus that senile skin pruritus and some systemic disease such as diabetes, liver and gall diseases, internal tumor, chronic renal insufficiency, abnormal thyroid function etc. cause.The treatment of senile skin pruritus, doctor trained in Western medicine are based on antihistaminic, calcium preparation, vitamin and various sedative hypnotic drug.Some obstinate skin prurituss, but fit applications gonadal hormone preparation, clinical efficacy is still difficult satisfactory.Listing treatment skin pruritus or skin pruritus are that main Chinese patent medicine for oral administration has: the noxious dampness clearing capsule at present, WUSHE ZHIYANG WAN, the skin granule of itching, urticaria ball, wind-repellent itching-relieving granules, these medicines are many from the damp and hot argument of blood deficiency, contain and the skin pruritus of obstinate or outbreak repeatedly and geroderma pruritus belong to deficiency of YIN endogenous dryness, the heat in blood stasis of blood is stagnant, ailment said due to cold or exposure is interior.Treatment deficiency of YIN wind-dryness type skin pruritus still belongs to rarely with the Chinese medicine preparation that clearly with the senile skin pruritus is indication at present.
Summary of the invention
The technical problem that the present invention solves is: but a kind of Chinese medicine that contains for the treatment of skin pruritus and senile skin pruritus of research and development is put forward the pharmaceutical composition of thing and the preparation method of suitability for industrialized production thereof, mainly is to solve obstinate or the skin pruritus of outbreak repeatedly and the technical barrier of senile skin pruritus.。Described medicine has nourishing YIN to relieve dryness, the removing heat from blood collateral dredging, and the wind dispelling itching-relieving action is with the purpose that reaches treating both the principal and secondary aspects of a disease, curative effect raising and consolidate.
For addressing the above problem, the invention provides following technical scheme: mainly select Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima to make up, the combination of these crude drug makes each efficacy of drugs produce synergism, with nourishing YIN to relieve dryness, removing heat from blood collateral dredging, wind dispelling is antipruritic is purpose.The Radix Polygoni Multiflori Preparata of wherein selecting for use: nature and flavor hardship, sweet, puckery, warm.Return liver, the heart, kidney channel.Function nourishing YIN and benefiting blood, loosening bowel to relieve constipation, the detoxifcation of dispeling the wind.Be used for the dizzy tinnitus due to the hepatic and renal YIN deficiency and the blood deficiency, soreness of the waist and knees, early whitening of beard and hair, palpitation and insomnia, dryness of the intestine constipation, rubella pruritus etc." China book on Chinese herbal medicine ": " but the Radix Polygoni Multiflori blood enriching and dryness moistening is controlled the skin pruritus, skin ulcer rash of wind syndrome due to blood-deficiency etc." Cortex Moutan: nature and flavor hardship, suffering are slightly cold.GUIXIN, liver, kidney channel.The function clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.Be used for the pathogenic heat attacking blood system in febrile diseases, maculae caused by violent heat pathogen, night fever abating at dawn, lossless hectic fever due to YIN-deficiency, carbuncle sore tumefacting virus falls and pounces on the pain of injury etc.The Radix Paeoniae Alba: nature and flavor hardship, acid are slightly cold.Return liver, spleen channel.Function nourishes blood and seeks, relieving spasm to stop pain, yin fluid astringing suppressing the hyperactive liver." Prescriptions for Universal Relief ": with Radix Polygoni Multiflori, Radix Paeoniae compatibility, control the prolonged deficiency ailment said due to cold or exposure and stagnate, brothers' flaccidity is slow, limb paralysis and skin pruritus.Pheretima: nature and flavor are salty, cold.Return liver, spleen, urinary bladder channel.Function heat clearing away relieving convulsion, suppressing the hyperactive liver to relieve the wind syndrome, dredge the meridian passage.
Specifically make by following bulk drugs:
Radix Polygoni Multiflori Preparata 1-4 part, Radix Paeoniae Alba 1-4 part, Cortex Moutan 1-4 part, Pheretima 1-4 part.Wherein material medicine preferably consumption be 2.5 parts of Radix Polygoni Multiflori Preparatas, 2.08 parts of the Radix Paeoniae Albas, 2.5 parts of Cortex Moutans, 2.08 parts of Pheretimas.
The preparation method of described medicine, it comprises the following steps:
Weighting raw materials thing Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima, standby.The Pheretima ethanol extraction, Radix Polygoni Multiflori Preparata, Radix Paeoniae Alba water extraction, concentrating alcohol extract and water extract to relative density respectively is 1.25-1.30 (60 ℃ of surveys); The distillate β-CDBao He is collected in the distillation of the Paeonia suffruticosa severe edema due to hypofunction of the spleen, gets beta-CD inclusion, adds the conventional formulation adjuvant, mixes, and makes conventional oral preparations, as pill, tablet, granule, capsule etc.
In order to reach better therapeutic, pharmaceutical composition of the present invention also makes up with Cornu Bubali, Scorpio, Cortex Dictamni, Spina Gleditsiae.Cornu Bubali: nature and flavor hardship, cold.GUIXIN, Liver Channel.Function heat-clearing and toxic substances removing, removing heat from blood.Be used for the epidemic febrile disease hyperpyrexia, send out speckle dermexanthesis etc.Scorpio: the nature and flavor suffering, flat; Poisonous.Return Liver Channel.The function endogenous wind stopping is antipruritic, dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain.Be used to the spasm of twitching, hemiplegia, rheumatoid arthritis stubborn, migraine and general headache, skin infection etc.Cortex Dictamni: nature and flavor hardship, cold.Return spleen, stomach, urinary bladder channel.Function heat clearing and damp drying, the detoxifcation of dispeling the wind.Be used for damp and hot sore, yellow fluid is dripping, eczema, rubella, scabies skin ulcer leprosy." Shengji Zonglu " Cortex Dictamni looses: " control the lungs wind heat, poison is attacked skin pruritus." Spina Gleditsiae: nature and flavor suffering, temperature.Return liver, stomach warp.The swollen clearly poison holding of function is searched wind, parasite killing." book on Chinese herbal medicine converges and says ": " treatment wind leprosy disease, tinea corporis wind skin ulcer, pruritus wind bits.”
In the aforementioned medicine, also add Cornu Bubali 4.5-7.5 part, Scorpio 0.5-1 part and/or Cortex Dictamni 1-3 part, Spina Gleditsiae 1-3 part, its preparation method comprises the following steps: weighting raw materials thing Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima, Pheretima, Cornu Bubali, Scorpio and or Cortex Dictamni, Spina Gleditsiae, standby.Pheretima, Cortex Dictamni ethanol extraction; Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Spina Gleditsiae, Cornu Bubali water extraction concentrate alcohol extract and water extract respectively, get relative density 1.25-1.30 (60 ℃ of surveys) thick paste; Scorpio is ground into fine powder; The distillate β-CDBao He is collected in the distillation of Cortex Moutan water, gets beta-CD inclusion, adds the conventional formulation adjuvant, mixes, and makes conventional oral preparations.
In order to obtain optimum curative effect, pharmaceutical composition of the present invention can also add Fructus Gleditsiae Abnormalis, Ramulus Mori, Radix Rhapontici, Fructus Liquidambaris on the basis of said medicine.This is because Fructus Gleditsiae Abnormalis: nature and flavor suffering, salty, warm.Return lung, large intestine channel.Function is eliminated the phlegm and is had one's ideas straightened out, mass dissipating and swelling eliminating." Standards of Diagnosis and Treatment ": " controlling the tinea scabies itches and can not bear." Ramulus Mori: property mildly bitter flavor, flat.Return Liver Channel.The function wind-damp dispelling, the meridian dredging, sharp joint.Be used for rheumatic arthralgia, apoplectic hemiplegia, human body pruritus due to wind pathogen etc." near efficacious prescriptions ": " treatment " all over body pruritus due to wind pathogen drying.Radix Rhapontici: nature and flavor hardship, cold.Return the stomach warp.The function heat-clearing and toxic substances removing, relaxing muscles and tendons to promote blood circulation.Be used for ulcer sore pain, scrofula sore, scabies convulsion rash, arthralgia chiefly caused by damp pathogen contracture etc." property of medicine opinion ": " pyretic toxicity on the training the body, malignant boil humorously, musculus cutaneus pruritus urticaria." Fructus Liquidambaris: nature and flavor hardship, flat.Return liver, kidney channel.The function dispelling, collateral-activating.Be used for arthralgia, numbness contracture, eczema, rubella, urticaria etc.So be equipped with medicine, heighten the effect of a treatment.
In the aforementioned drug regimen, remove adding Cornu Bubali 4.5-7.5 part, Scorpio 0.5-1 part and/or Cortex Dictamni 1-3 part, Spina Gleditsiae 1-3 part also can add Fructus Gleditsiae Abnormalis 0.3-1 part again, Ramulus Mori 1-4 part, Radix Rhapontici 1-4 part, Fructus Liquidambaris 1-4 part; Through a large amount of experiment sievings, summary draws the consumption of crude drug component of the present invention, each amounts of components is that the following weight parts scope all has curative effect preferably: its proportioning is: 2.5 parts of Radix Polygoni Multiflori Preparatas, 2.08 parts of the Radix Paeoniae Albas, 2.5 parts of Cortex Moutans, 2.08 parts of Pheretimas, 6.25 parts of Cornu Bubalis, 0.83 part of Scorpio, 2.08 parts of Cortex Dictamni, 2.08 parts of Spina Gleditsiaes, 0.645 part of Fructus Gleditsiae Abnormalis, 2.5 parts of Ramulus Moris, 2.08 parts of Radix Rhapontici, 2.08 parts of Fructus Liquidambaris.
Described preparation of drug combination method comprises the following steps: weighting raw materials Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima, Cornu Bubali, Scorpio, Cortex Dictamni, Spina Gleditsiae, Fructus Gleditsiae Abnormalis, Ramulus Mori, Radix Rhapontici, Fructus Liquidambaris, and is standby.Pheretima, Radix Rhapontici, Cortex Dictamni ethanol extraction; Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Spina Gleditsiae, Cornu Bubali, Ramulus Mori, Fructus Gleditsiae Abnormalis water extraction concentrate alcohol extract and water extract, relative density 1.25-1.30 (60 ℃ of surveys) thick paste respectively; Scorpio is ground into fine powder; The distillate β-CDBao He is collected in Cortex Moutan, the distillation of Fructus Liquidambaris water, gets beta-CD inclusion, adds the conventional formulation adjuvant, mixes, and makes conventional oral formulations.
Described pharmaceutical composition is preparation method preferably: take by weighing Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima, Cornu Bubali, Scorpio, Cortex Dictamni Fructus Gleditsiae Abnormalis, Ramulus Mori, Radix Rhapontici, Fructus Liquidambaris.Pheretima powder is broken into coarse powder, adds 30 ℃ of-70 ℃ of warm macerating twice of 30-70% ethanol, and 3-7 doubly measures 48 hours for the first time; For the second time 2-6 doubly measures, and 48 hours, merge warm macerating liquid, it is standby to be evaporated to relative density 1.25-1.30 (60 ℃ of surveys) thick paste; Radix Rhapontici, Cortex Dictamni powder are broken into coarse powder, add 70-95% alcohol reflux twice, and 4-8 doubly measures 2 hours for the first time; 3-7 doubly measures for the second time, and 1.5 hours, it is standby that merge extractive liquid,, decompression recycling ethanol are concentrated into relative density 1.25-1.30 (60 ℃ of surveys) thick paste; Cortex Moutan, Fructus Liquidambaris add 8-15 times of water gaging distillation, collect distillation 700-1100ml, add β-CDBao He, 20 ℃-45 ℃ of enclose temperature, and the enclose time is 1-4 hour, it is standby to get beta-CD inclusion; Cornu Bubali adds 8-15 times of decocting and boiled 3 hours, merge with surplus medicines such as Radix Polygoni Multiflori Preparata after soaking in 1 hour, the Radix Paeoniae Alba, Spina Gleditsiaes, decoct with water secondary, add 8-15 times of decocting for the first time to boil 1-3 hour, for the second time with distillation after medicinal residues and ethanol extraction medicinal residues merge, add 8-15 times of decocting and boiled 1.5 hours, filter, the medicinal liquid of filtrate and distillation extraction merges, be evaporated to relative density and be about the thick paste of 1.25-1.30 (60 ℃ of surveys), merge with pure extractum, vacuum drying, powder gets dry extract.Scorpio is ground into fine powder, and it is standby to sterilize, and dried cream powder adds Scorpio powder, beta-CD inclusion, adds right amount of auxiliary materials, and oral formulations commonly used such as capsule, granule, tablet is made in mixing, granulation.
Pharmaceutical composition of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into multiple conventional oral preparations.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into multiple peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as pill, tablet, oral liquid, capsule, granule etc.Can also adopt CO among the medicine activity component preparation technology of the present invention
2Supercritical extraction, microencapsulation enclose, micronization technology.
Pharmaceutical composition of the present invention has nourishing YIN to relieve dryness, and removing heat from blood collateral dredging, the antipruritic effect of wind dispelling are applicable to that deficiency of YIN wind contains, and disease is seen skin pruritus, and becoming severe at night rises one after another, and skin is scorching hot, drying, and scratch is innumerable or be bitter tinea sample and become.Dysphoria with feverish sensation in the chest palms and soles, dry throat and mouth, difficulty in defecation, dimly red tongue etc., and skin pruritus especially senile pruritus above-mentioned proposita is arranged.
Preparation of drug combination technology of the present invention is through orthogonal test, screened better, best preparation by way of.Adopt suitable purification of tcm technology, and screen reasonable pharmaceutical adjunct, prescription and formulation method, active ingredient is extracted fully, extraction efficiency height, and not volatile or decomposition in preparation and use guarantee that drug quality is stable, determined curative effect is reliable.
The specific embodiment
The present invention is described in detail below in conjunction with embodiment.
Embodiment 1: capsule
Take by weighing each crude drug by following weight proportion:
Radix Polygoni Multiflori Preparata 250g Radix Paeoniae Alba 208g Cortex Moutan 250g
Pheretima 208g Cornu Bubali 625g Scorpio 83g
Cortex Dictamni 208g Spina Gleditsiae 208g Fructus Gleditsiae Abnormalis 64.5g
Ramulus Mori 250g Radix Rhapontici 208g Fructus Liquidambaris 208g
More than 12 the flavor medicines, Scorpio is ground into fine powder, the sterilization, standby; Pheretima powder is broken into coarse powder, adds 50 ℃ of warm macerating twice of 50% ethanol, for the first time 5 times of amounts, 48 hours, and 4 times of amounts, 48 hours for the second time, merging warm macerating liquid, being evaporated to relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Radix Rhapontici, Cortex Dictamni powder are broken into coarse powder, add 80% alcohol reflux twice, for the first time 6 times of amounts, 2.0 hours, the second time 5 times of amounts, 1.5 hours, merge extractive liquid,, decompression recycling ethanol, being concentrated into relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Cortex Moutan, Fructus Liquidambaris add 12 times of water gaging distillations, collect the about 900ml of distillate, add the 48g β-CDBao He, and the enclose temperature is 30 ℃, and the enclose time is 3 hours, and it is standby to get beta-CD inclusion; Cornu Bubali adds 12 times of water gagings and decocted 3 hours, with the Radix Polygoni Multiflori Preparata after soaking in 1 hour, the Radix Paeoniae Alba, surplus medicine such as Spina Gleditsiae merges, decoct with water secondary, adding for the first time 12 times of water gagings decocted 2 hours, for the second time with distillation after medicinal residues and the medicinal residues after the alcohol extraction merge, add 10 times of water gagings and decocted 1.5 hours, filter, the medicinal liquid of filtrate and distillation extraction merges, be evaporated to relative density and be about the thick paste of 1.25-1.3.0 (60 ℃ of surveys), merge vacuum drying (vacuum 0.08-0.09Mpa with pure extractum, temperature 70-80 ℃), the about 250g of the powder that gets dry extract adds the about 75g of Scorpio fine powder, the about 43g of beta-CD inclusion, mixing, with 90% ethanol system soft material, cross 40 mesh sieve system wet granulars, 60-80 ℃ of cold drying, granulate, adorn capsule No. 1, make about 1000 altogether.Usage and dosage: oral, one time 4,3 times on the one.Two weeks of the course of treatment.
Embodiment 2: tablet
Take by weighing each crude drug by following weight proportion:
Radix Polygoni Multiflori Preparata 250g Radix Paeoniae Alba 208g Cortex Moutan 250g
Pheretima 208g Cornu Bubali 625g Scorpio 83g
Cortex Dictamni 208g Spina Gleditsiae 208g Fructus Gleditsiae Abnormalis 64.5g
Ramulus Mori 250g Radix Rhapontici 208g Fructus Liquidambaris 208g
More than 12 the flavor medicines, Scorpio is ground into fine powder, the sterilization, standby; Pheretima powder is broken into coarse powder, adds 50 ℃ of warm macerating twice of 50% ethanol, for the first time 5 times of amounts, 48 hours, and 4 times of amounts, 48 hours for the second time, merging warm macerating liquid, being evaporated to relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Radix Rhapontici, Cortex Dictamni powder are broken into coarse powder, add 80% alcohol reflux twice, for the first time 6 times of amounts, 2.0 hours, the second time 5 times of amounts, 1.5 hours, merge extractive liquid,, decompression recycling ethanol, being concentrated into relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Cortex Moutan, Fructus Liquidambaris add 12 times of water gaging distillations, collect the about 900ml of distillate, add the 48g β-CDBao He, and the enclose temperature is 30 ℃, and the enclose time is 3 hours, and it is standby to get beta-CD inclusion; Cornu Bubali adds 12 times of water gagings and decocted 3 hours, with the Radix Polygoni Multiflori Preparata after soaking in 1 hour, the Radix Paeoniae Alba, surplus medicine such as Spina Gleditsiae merges, decoct with water secondary, adding for the first time 10 times of water gagings decocted 2 hours, for the second time with distillation after medicinal residues and alcohol extraction after medicinal residues merge, add 8 times of water gagings and decocted 1.5 hours, filter, the medicinal liquid of filtrate and distillation extraction merges, be evaporated to relative density and be about the thick paste of 1.25-1.30 (60 ℃ of surveys), merge vacuum drying (vacuum 0.08-0.09Mpa, temperature 70-80 ℃) with pure extractum, the about 250g of the powder that gets dry extract, add the about 75g of Scorpio fine powder, the about 43g of beta-CD inclusion, mixing is used 90% alcohol granulation, 60-80 ℃ of cold drying, add an amount of magnesium stearate, compressed tablets is made about 1000.Usage and dosage: oral, one time 4,3 times on the one.Two weeks of the course of treatment.
Embodiment 3: granule
Take by weighing each crude drug by following weight proportion:
Radix Polygoni Multiflori Preparata 250g Radix Paeoniae Alba 208g Cortex Moutan 250g
Pheretima 208g Cornu Bubali 625g Scorpio 83g
Cortex Dictamni 208g Spina Gleditsiae 208g Fructus Gleditsiae Abnormalis 64.5g
Ramulus Mori 250g Radix Rhapontici 208g Fructus Liquidambaris 208g
More than 12 the flavor medicines, Scorpio is ground into fine powder, the sterilization, standby; Pheretima powder is broken into coarse powder, adds 50 ℃ of warm macerating twice of 50% ethanol, for the first time 5 times of amounts, 48 hours, and 4 times of amounts, 48 hours for the second time, merging warm macerating liquid, being evaporated to relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Radix Rhapontici, Cortex Dictamni powder are broken into coarse powder, add 80% alcohol reflux twice, for the first time 6 times of amounts, 2.0 hours, the second time 5 times of amounts, 1.5 hours, merge extractive liquid,, decompression recycling ethanol, being concentrated into relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Cortex Moutan, Fructus Liquidambaris add 12 times of water gaging distillations, collect the about 900ml of distillate, add the 48g β-CDBao He, and the enclose temperature is 30 ℃, and the enclose time is 3 hours, and it is standby to get beta-CD inclusion; Cornu Bubali adds 12 times of water gagings and decocted 3 hours, with the Radix Polygoni Multiflori Preparata after soaking in 1 hour, the Radix Paeoniae Alba, surplus medicine such as Spina Gleditsiae merges, decoct with water secondary, adding for the first time 10 times of water gagings decocted 2 hours, for the second time with distillation after medicinal residues and alcohol extraction after medicinal residues merge, adding 8 times of water gagings decocted 1.5 hours, filter, the medicinal liquid of filtrate and distillation extraction merges, and is evaporated to the thick paste that relative density is about 1.25-1.30 (60 ℃ of surveys), merge with pure extractum, vacuum drying (vacuum 0.08-0.09Mpa, temperature 70-80 ℃), the about 250g of the powder that gets dry extract, add the about 75g of Scorpio fine powder, the about 43g of beta-CD inclusion, mixing is used 90% alcohol granulation, 60-80 ℃ of cold drying, make about 1500g, be distributed into 100 bags.Usage and dosage: oral, one time 1 bag, 3 times on the one.Two weeks of the course of treatment.
Embodiment 4: pill
Take by weighing each crude drug by following weight proportion:
Radix Polygoni Multiflori Preparata 250g Radix Paeoniae Alba 208g Cortex Moutan 250g
Pheretima 208g Cornu Bubali 625g Scorpio 83g
Cortex Dictamni 208g Spina Gleditsiae 208g Fructus Gleditsiae Abnormalis 64.5g
Ramulus Mori 250g Radix Rhapontici 208g Fructus Liquidambaris 208g
More than 12 the flavor medicines, Scorpio is ground into fine powder, the sterilization, standby; Pheretima powder is broken into coarse powder, adds 50 ℃ of warm macerating twice of 50% ethanol, for the first time 5 times of amounts, 48 hours, and 4 times of amounts, 48 hours for the second time, merging warm macerating liquid, being evaporated to relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Radix Rhapontici, Cortex Dictamni powder are broken into coarse powder, add 80% alcohol reflux twice, for the first time 6 times of amounts, 2.0 hours, the second time 5 times of amounts, 1.5 hours, merge extractive liquid,, decompression recycling ethanol, being concentrated into relative density is that 1.25-1.30 (60 ℃ of surveys) thick paste is standby; Cortex Moutan, Fructus Liquidambaris add 12 times of water gaging distillations, collect the about 900ml of distillate, add the 48g β-CDBao He, and the enclose temperature is 30 ℃, and the enclose time is 3 hours, and it is standby to get beta-CD inclusion; Cornu Bubali adds 12 times of water gagings and decocted 3 hours, with the Radix Polygoni Multiflori Preparata after soaking in 1 hour, the Radix Paeoniae Alba, surplus medicine such as Spina Gleditsiae merges, decoct with water secondary, adding for the first time 10 times of water gagings decocted 2 hours, for the second time with distillation after medicinal residues and alcohol extraction after medicinal residues merge, add 8 times of water gagings and decocted 1.5 hours, filter, the medicinal liquid of filtrate and distillation extraction merges, be evaporated to relative density and be about the thick paste of 1.25-1.30 (60 ℃ of surveys), merge vacuum drying (vacuum 0.08-0.09Mpa with pure extractum, temperature 70-80 ℃), the about 250g of the powder that gets dry extract adds the about 75g of Scorpio fine powder, the about 43g of beta-CD inclusion, mixing, the general micropill of making of water, coating hits light, drying, make 1000g, every packed 1.2g.Usage and dosage: oral, a 1.2g, 3 times on the one.Two weeks of the course of treatment.
Embodiment 5: oral liquid
Take by weighing each crude drug by following weight proportion:
Radix Polygoni Multiflori Preparata 250g Radix Paeoniae Alba 208g Cortex Moutan 250g
Pheretima 208g Cornu Bubali 625g Scorpio 83g
Cortex Dictamni 208g Spina Gleditsiae 208g Fructus Gleditsiae Abnormalis 64.5g
Ramulus Mori 250g Radix Rhapontici 208g Fructus Liquidambaris 208g
More than 12 flavor medicines, Pheretima powder is broken into coarse powder, adds 50 ℃ of warm macerating twice of 50% ethanol, for the first time 5 times of amounts, 48 hours, 4 times of amounts, 48 hours for the second time, merging warm macerating liquid, filtration, filtrate for later use; Scorpio is ground into fine powder, and Radix Rhapontici, Cortex Dictamni powder are broken into coarse powder, adds 80% alcohol reflux twice, for the first time 6 times of amounts, 2.0 hours, 5 times of amounts, 1.5 hours for the second time, merge extractive liquid,, decompression recycling ethanol, filtration, filtrate for later use; Cortex Moutan, Fructus Liquidambaris add 12 times of water gaging distillations, collect the about 900ml of distillate, add the 48g β-CDBao He, and the enclose temperature is 30 ℃, and the enclose time is 3 hours, and it is standby to get beta-CD inclusion; Cornu Bubali adds 12 times of water gagings and decocted 3 hours, with the Radix Polygoni Multiflori Preparata after soaking in 1 hour, the Radix Paeoniae Alba, surplus medicine such as Spina Gleditsiae merges, decoct with water secondary, adding for the first time 10 times of water gagings decocted 2 hours, for the second time with distillation after medicinal residues and alcohol extraction after medicinal residues merge, add 8 times of water gagings and decocted 1.5 hours, filter, the medicinal liquid of filtrate and distillation extraction merges, add about 43g of beta-CD inclusion and above-mentioned water extract, alcohol extract transfers pH value to 4.5-5.5, and cold preservation filtered more than 12 hours, filtrate water and sucrose, boiled 30 minutes, and put that to add correctives after cold an amount of, add water to 2000ml, stir evenly fill.Usage and dosage: oral, a 10ml, 3 times on the one.Two weeks of the course of treatment.
Embodiment 6:
Take by weighing each crude drug by following weight proportion: Radix Polygoni Multiflori Preparata 250g, Radix Paeoniae Alba 208g, Cortex Moutan 250g, Pheretima 208g, and make pharmaceutical composition of the present invention by embodiment 1 identical method.
Embodiment 7:
Take by weighing each crude drug by following weight proportion: Radix Polygoni Multiflori Preparata 250g, Radix Paeoniae Alba 208g, Cortex Moutan 250g, Pheretima 208g, Cornu Bubali 625g, Scorpio 83g, Cortex Dictamni 208g, Spina Gleditsiae 208g, Fructus Gleditsiae Abnormalis 64.5g, and make pharmaceutical composition of the present invention by embodiment 2 identical methods.
Embodiment 8:
Take by weighing each crude drug by following weight proportion: Radix Polygoni Multiflori Preparata 250g, Radix Paeoniae Alba 208g, Cortex Moutan 250g, Pheretima 208g, Cornu Bubali 625g, Scorpio 83g, Spina Gleditsiae 208g, Fructus Gleditsiae Abnormalis 64.5g, Ramulus Mori 250g, Radix Rhapontici 208g, Fructus Liquidambaris 208g; Make pharmaceutical composition of the present invention by embodiment 3 identical methods.
Embodiment 9:
Take by weighing Radix Polygoni Multiflori Preparata 100g, Radix Paeoniae Alba 400g, Cortex Moutan 280g, Pheretima 330g, Cornu Bubali 480g, Scorpio 90g, Cortex Dictamni 250g, Spina Gleditsiae 300g, Fructus Gleditsiae Abnormalis 80g, Ramulus Mori 350g, Radix Rhapontici 280g, Fructus Liquidambaris 360g; Make pharmaceutical composition of the present invention by embodiment 4 identical methods.
Embodiment 10:
Take by weighing Radix Polygoni Multiflori Preparata 150g, Radix Paeoniae Alba 250g, Cortex Moutan 180g, Pheretima 300g, Cornu Bubali 650g, Scorpio 80g, Cortex Dictamni 250g, Spina Gleditsiae 200g, Fructus Gleditsiae Abnormalis 80g, make pharmaceutical composition of the present invention by embodiment 5 identical methods.
Below further sets forth the beneficial effect of medicine of the present invention by testing example, these are tested the routine pharmacodynamics test of medicine of the present invention and the clinical observation on the therapeutic effect of having comprised and test.
One, animal acute toxicity test
1, test objective: after observing that pharmaceutical composition of the present invention is disposable and giving animal, toxic reaction that is produced and death condition.
2, test material:
2.1 medicine
Pharmaceutical composition of the present invention is prepared into extractum by the inventive method, Jiangxi QingFeng Pharmacy Co., Ltd.Lot number: 20030806.Extractum concentration: 7.92g (crude drug)/g.Clinical plan consumption is 33.25g/ day, and being made into maximum aqueous suspension concentration during test is 3.0g/ml.
50 of 2.2 animal: ICR system cleaning level mices, male and female half and half, body weight 18-20g, provide by our company's Experimental Animal Center, mice begins test at temperature 22-28 ℃ after the observation ward of temperature 50-60% adapts to 7 days, wherein changes the sterilization wood flour every day 1 time, uviol lamp sterilization 1 time is ventilated each 1 time sooner or later.
3, test method:,, measure maximum dosage-feeding owing to can not ask LD50 according to pre-test result.Get 20 of mices, male and female half and half, water 12h is can't help in fasting, presses 0.8ml/20g dosage and irritates the stomach mice, interior three times of 24h.Observed 7 days record reaction of animals situation and death condition after the administration continuously.
4, result of the test:
After each administration, animal rolls up less moving, and it is normal that about 10-30min recovers, and observed continuously 7 days, and animal does not see that other is unusual, does not also have animal dead.After putting to death animal, internal organs such as the perusal heart, liver, spleen, lung, kidney, all no abnormal and pathological changes.This moment, the accumulation dosage of mice was that maximum dosage-feeding reaches 432g/kg, was equivalent to 785 times of clinical medicine dose.Repeat above-mentioned test once, come to the same thing, see table one for details.
Table one pharmaceutical composition The acute toxicity tests of the present invention
Lot number | Give through the medicine way | (a moving thing) number | (g medicine/amount kg | (g amount/kg | The bed that medicine faces the number of phases ought doubly be used for | Between see (examine day time) | Different condition reason | Separate condition and cut open feelings | (extremely only dying) number | Tuple is criticized again |
20030806 | Irritate stomach | ??20 | ??432 | ??0.55 | ??785 | ??7 | Do not have | Normally | ??0 | ??1 |
5, discuss: by above result as seen, when this medicinal pharmaceutical quantities reaches 785 times of clinical consumption, the animal no abnormality seen, also dead, show that the disposable medication of this medicine is safer.
6, conclusion: the disposable medication of pharmaceutical composition of the present invention is than safety.
Two, histamine phosphate is caused the itching-relieving action of Cavia porcellus pruritus.
1, test material
1.1 medicine and reagent:
The extractum that drug regimen of the present invention is made, concentration are 7.92g (crude drug)/g, Jiangxi QingFeng Pharmacy Co., Ltd, and lot number: 20030806, clinical plan consumption is 33.25g/ day.
Positive drug: WUSHE ZHIYANG WAN, its Main Ingredients and Appearance has Zaocys, Fructus Cnidii, artificial Calculus Bovis, Radix Angelicae Sinensis, Cortex Moutan, Radix Sophorae Flavescentis, Radix Saposhnikoviae, Rhizoma Atractylodis etc., has nourishing blood to expel wind, the merit of dampness removing to stop itchin.Be used for diseases such as skin pruritus, urticaria.Specification: 30g/ bottle, clinical consumption 7.5g/ day, Guangzhou No.1 Chinese Pharmacy Factory production, lot number: 20030409.
Histamine phosphate, Shanghai Inst. of Biochemistry, Chinese Academy of Sciences produces, lot number: 20000510.
Other reagent is CR.
1.2 animal
Cavia porcellus, 50, male and female half and half, body weight 250-400g is provided by Jiangxi QingFeng Pharmacy Co., Ltd's Experimental Animal Center.
" laboratory animal occupancy permit ", credit number: SYXK (Jiangxi) 2003-0001.
2, method and result
2.1 method:
Get 50 of Cavia porcelluss, male and female half and half, body weight 250-400g is divided into 5 groups at random, is respectively (1) blank group (irritating stomach normal saline 5ml/kg); (2) WUSHE ZHIYANG WAN group (dose,equivalent is 0.60g/kg); (3) (4) (5) are the basic, normal, high dosage group of pharmaceutical composition extractum of the present invention (its dosage is respectively 2.6,5.3,10.6g/kg, is equivalent to clinical isodose 1,2,4 times).1h sloughs right instep hair with 8% sodium sulfide before test, abrades skin of unhairing with coarse sandpaper, is advisable the about 1cm of area with oozing of blood
2After each treated animal is irritated stomach relative medicine 5ml/kg30min, get the solution 0.05ml of histamine phosphate and be applied to the scratch mark place, Cavia porcellus pruritus do not occur and does not promptly later lick right back foot and then increase progressively histamine phosphate's concentration in the 3min, till licking right back foot, the concentration of histamine phosphate's solution is 0.01%, 0.02%, 0.03%, 0.04% ... incremental method always.The consumption of last cumulative calculation histamine phosphate compares, and sees Table two.
Table two pair histamine phosphate causes the influence (X ± SD) of Cavia porcellus pruritus
Group | Number of animals (only) | Dosage | Amount (the μ of accumulative total histamine phosphate |
The blank group | ????10 | ????NS | ?90.50±54.35 |
The WUSHE ZHIYANG WAN group | ????10 | ????0.6 | ?218.00±128.80※ |
Pharmaceutical composition hangs down agent | ????10 | ????2.6 | ?381.00±211.36※※# |
Agent in the pharmaceutical composition | ????10 | ????5.3 | ?387.00±190.34※※# |
The agent of drug regimen object height | ????10 | ????10.6 | ?407.00±165.68※※ |
Compare ※ P<0.05, ※ ※ P<0.01 with the blank group; Compare #P<0.05, ##P<0.01 with the WUSHE ZHIYANG WAN group.
2.2 result
As seen from the table, compare with the blank group, the basic, normal, high dosage tissue accumulation of pharmaceutical composition of the present invention histamine phosphate amount has significant difference, its histamine phosphate's dosis tolerata obviously improves, show that pharmaceutical composition of the present invention causes that to histamine phosphate the Cavia porcellus pruritus has good inhibitory effect, has certain itching-relieving action.Its itching-relieving action to histamine phosphate's pruritus is better than the positive control drug WUSHE ZHIYANG WAN.
Three, the clinical observation of medicine composite for curing skin pruritus of the present invention.
1, physical data
The clinical observation case is totally 50 examples, wherein male 23 examples, women 27 examples, age 18-30 year 8 examples, 31-40 year 10 examples, 41-50 year 15 examples, 17 examples more than 50 years old.
2, diagnostic criteria
(1) general skin pruritus: whole body skin is itched and is not had fixed place or general property skin pruritus, and attach most importance to night, xerosis cutis, and scratch is obvious.
(2) limitation skin pruritus: gargalesthesia is confined to a certain position of health more, locates as anus, cysthus, scrotum etc., and the affected part is owing to long-term pruritus sees that infiltration is plump, and the lichen sample becomes and eczematization.
(3) deficiency of YIN wind is contained the disease diagnosis
Primary symptom: 1. skin pruritus, becoming severe at night or/and rise one after another; 2. red tongue or red partially, TAIGAN (sic) or flower stripping; 3. skin is scorching hot or dry.
Inferior disease: 1. scratch is innumerable or be the lichen sample and become; 2. dysphoria with smothery sensation; 3. dry throat and mouth; 4. difficulty in defecation; 5. stringy and thready pulse or stringy and thready pulse number.
3, Therapeutic Method
3.1 observe routine number: observe 50 examples at 3: 2 by treatment group and matched group.
3.2 group technology: at first will intend observing the case load serial number and be divided into 5 groups with table of random number.Adopt lottery to extract wherein 3 groups out then and merge into the treatment group, merge into matched group for all the other 2 groups.
3.3 dosage regimen
3.3.1 usage and dosage:
1. treatment group: the capsule that pharmaceutical composition of the present invention is made (Jiangxi QingFeng Pharmacy Co., Ltd produces, lot number 20030806), oral, each 4,3 times on the one.
2. matched group: oral, the each 10g of the ball of itching on the Zaocys (Guangzhou No.1 Chinese Pharmacy Factory production, lot number 20030409), 3 times on the one.
3.3.2 the course of treatment: 2 weeks
4, efficacy assessment standard
4.1 clinical recovery: the pruritus complete obiteration, the secondary skin lesion disappears substantially.
4.2 produce effects: pruritus obviously alleviates, and secondary skin obviously improves.
4.3 effectively: pruritus alleviates, and the secondary skin lesion makes moderate progress.
4.4 invalid: pruritus and secondary skin lesion improve not obvious.
5, efficacy result
5.1 deficiency of YIN wind Sheng type skin pruritus curative effect,
Imitate observation through a course of therapy.See Table three
Total routine number | Clinical recovery | Produce effects | Effectively | Invalid | Clinical recovery rate % | Total obvious effective rate % | |
The treatment group | ????32 | ??20 | ????5 | ????4 | ????3 | ??62.5 | ??90.63 |
Matched group | ????18 | ??7 | ????3 | ????4 | ????4 | ??38.89 | ??77.78 |
Compare between group: P<0.05
This shows explanation, and the clinical recovery rate of medicine composite for curing skin pruritus of the present invention is 62.5%, and total effective rate is 90.63%, and the prison bed cure rate of contrast medicine, total effective rate is respectively 38.89%, 77.78%.Learn by statistics and handle, curative effect difference has significant difference (P<0.05) between group.
5.2 disease card disease is levied integration situation of change (X ± SD) before and after the treatment.See Table four
The example number | Before the treatment | After the treatment | The front and back difference | |
The treatment group | ??32 | ??31.15±14.33 | ??8.53±6.42 ▲▲ | ??12.62±7.93※ ??※ |
Matched group | ??18 | ??28.87±13.61 | ??13.02±11.71 ▲?? ▲ | ??7.85±6.29 |
Compare before and after the group internal therapy:
▲ ▲Before and after P<0.01 treatment between the difference group relatively: ※ ※ P<0.01, last table explanation: disease disease is levied integration after treatment group and the matched group medication all obvious decline, and the former declines by a big margin, and treats the front and back difference and the latter relatively has statistical significance.Point out two medicines for deficiency of YIN wind Sheng type skin pruritus patient, all have significantly antipruritic and improve skin and General Symptoms effect, the curative action intensity is better than contrasting medicine.
6, safety observed result: do not find obvious adverse reaction in two groups of patient's medication processes.Have a blood test before the treatment, urine, stool routine examination and liver function (TP, ALT), renal function (BUN, Cr), do not have to find the ANOMALOUS VARIATIONS relevant with medicine.
Claims (8)
1, a kind of pharmaceutical composition for the treatment of skin pruritus and senile skin pruritus is characterized in that: made by following bulk drugs: Radix Polygoni Multiflori Preparata 1-4 part, Radix Paeoniae Alba 1-4 part, Cortex Moutan 1-4 part, Pheretima 1-4 part.
2, according to the described pharmaceutical composition of claim 1, it is characterized in that: wherein the consumption of crude drug is 2.5 parts of Radix Polygoni Multiflori Preparatas, 2.08 parts of the Radix Paeoniae Albas, 2.5 parts of Cortex Moutans, 2.08 parts of Pheretimas.
3, according to claim 1 or 2 described preparation of drug combination methods, it is characterized in that: it is standby that its preparation method comprises the following steps: to take by weighing raw material Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima; Pheretima is used ethanol extraction, and relative density is the 1.25-1.30 thick paste when getting 60 ℃ of surveys; Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba are used water extraction, and relative density is the 1.25-1.30 thick paste when getting 60 ℃ of surveys; The distillation of Cortex Moutan water is collected distillate and is added β-CDBao He, gets beta-CD inclusion, adds the conventional formulation adjuvant, mixes, and makes conventional oral formulations.
4, according to the described pharmaceutical composition of claim 1, it is characterized in that: wherein crude drug also has:
Cornu Bubali 4.5-7.5 part, Scorpio 0.5-1 part and/or Cortex Dictamni 1-3 part, Spina Gleditsiae 1-3 part.
5, according to the described pharmaceutical composition of claim 4, it is characterized in that: its preparation method comprises the following steps:
Get Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima, Cornu Bubali, Scorpio and/or Cortex Dictamni, Spina Gleditsiae is standby, Pheretima, Cortex Dictamni ethanol extraction, 60 ℃ of relative densities when surveying are the 1.25-1.30 thick paste; Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Spina Gleditsiae, Cornu Bubali water extraction, relative density is the 1.25-1.30 thick paste when getting 60 ℃ of surveys; Scorpio is ground into fine powder; The distillation of Cortex Moutan water is collected distillate and is added β-CDBao He, gets beta-CD inclusion; Add the conventional formulation adjuvant, mix, make conventional oral formulations.
6, according to the described pharmaceutical composition of claim 4, it is characterized in that: wherein crude drug also has:
Fructus Gleditsiae Abnormalis 0.3-1 part, Ramulus Mori 1-4 part, Radix Rhapontici 1-4 part, Fructus Liquidambaris 1-4 part.
7, according to the described pharmaceutical composition of claim 6, it is characterized in that: wherein the consumption of each component is:
2.5 parts of Radix Polygoni Multiflori Preparatas, 2.08 parts of the Radix Paeoniae Albas, 2.5 parts of Cortex Moutans, 2.08 parts of Pheretimas, 6.25 parts of Cornu Bubalis, 2.08 parts of 0.83 part of Scorpio and/or Cortex Dictamni, 2.08 parts of Spina Gleditsiaes, 0.645 part of Fructus Gleditsiae Abnormalis, 2.5 parts of Ramulus Moris, 2.08 parts of Radix Rhapontici, 2.08 parts of Fructus Liquidambaris.
8, according to the described pharmaceutical composition of claim 7, it is characterized in that: its preparation method comprises the following steps: weighting raw materials Radix Polygoni Multiflori Preparata, the Radix Paeoniae Alba, Cortex Moutan, Pheretima, Cornu Bubali, Scorpio, Cortex Dictamni, Fructus Gleditsiae Abnormalis, Ramulus Mori, Radix Rhapontici, Fructus Liquidambaris.Scorpio is ground into fine powder, and sterilization is standby; Pheretima powder is broken into coarse powder, adds 30 ℃ of-70 ℃ of warm macerating twice of 30-70% ethanol, and 3-7 doubly measures 48 hours for the first time; 2-6 doubly measures for the second time, and 48 hours, merge warm macerating liquid, relative density 1.25-1.30 thick paste is standby when being evaporated to 60 ℃ of surveys; Radix Rhapontici, Cortex Dictamni powder are broken into coarse powder, add 70-95% alcohol reflux twice, and 4-8 doubly measures 2 hours for the first time; 3-7 doubly measures for the second time, and 1.5 hours, relative density 1.25-1.30 thick paste was standby when merge extractive liquid,, decompression recycling ethanol were concentrated into 60 ℃ of surveys; Cortex Moutan, Fructus Liquidambaris add the distillation of 8-15 times of water gaging, collect distillation 700-1100ml, add β-CDBao He, 20 ℃-45 ℃ of enclose temperature, wrap full-time is 1-4 hour, must β-CD to wrap full thing standby; Cornu Bubali adds 8-15 times of decocting and boiled 3 hours, merge with surplus medicines such as Radix Polygoni Multiflori Preparata after soaking in 1 hour, the Radix Paeoniae Alba, Spina Gleditsiaes, decoct with water secondary, add 8-15 times of decocting for the first time to boil 1-3 hour, for the second time with distillation after medicinal residues and ethanol extraction medicinal residues merge, add 8-15 times of decocting and boiled 1.5 hours, filter, the medicinal liquid of filtrate and distillation extraction merges, be evaporated to relative density and be about the thick paste of 1.25-1.30 (60 ℃ of surveys), merge with pure extractum, vacuum drying, powder gets dry extract.Add Scorpio powder, beta-CD inclusion, add right amount of auxiliary materials, mixing is granulated, and makes multiple oral formulations commonly used, as pill, tablet, and capsule, granule, oral liquid.
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CN102973860A (en) * | 2012-12-18 | 2013-03-20 | 成都中医药大学 | Traditional Chinese medicine composition for treating skin itch as well as preparation method and application thereof |
CN105343552A (en) * | 2015-12-02 | 2016-02-24 | 卢雨萍 | Traditional Chinese medicine composition for treating herpes zoster |
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CN1446531A (en) * | 2002-03-22 | 2003-10-08 | 董景平 | Disinfection attendance liquid prepared from Chinese herbal medicine and its production methods |
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CN102973860A (en) * | 2012-12-18 | 2013-03-20 | 成都中医药大学 | Traditional Chinese medicine composition for treating skin itch as well as preparation method and application thereof |
CN102973860B (en) * | 2012-12-18 | 2014-07-30 | 成都中医药大学 | Traditional Chinese medicine composition for treating skin itch as well as preparation method and application thereof |
CN105343552A (en) * | 2015-12-02 | 2016-02-24 | 卢雨萍 | Traditional Chinese medicine composition for treating herpes zoster |
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