CN105617328A - Traditional Chinese medicine preparation for treating frostbite - Google Patents

Traditional Chinese medicine preparation for treating frostbite Download PDF

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Publication number
CN105617328A
CN105617328A CN201610049667.XA CN201610049667A CN105617328A CN 105617328 A CN105617328 A CN 105617328A CN 201610049667 A CN201610049667 A CN 201610049667A CN 105617328 A CN105617328 A CN 105617328A
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parts
radix
chinese medicine
medicine preparation
radix angelicae
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刘学键
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Qingdao Huazhicao Medical Technology Co Ltd
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Qingdao Huazhicao Medical Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/54Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • AHUMAN NECESSITIES
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/185Magnoliopsida (dicotyledons)
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract

The invention discloses a traditional Chinese medicine preparation for treating frostbite, belonging to the technical field of traditional Chinese medicine and traditional Chinese medicines. The traditional Chinese medicine preparation is prepared from cassia twig, Chinese date, cortex cinnamomi, radix astragali, Chinese angelica, ginger, radix saposhnikoviae, pepper, radix angelicae, fennel, rhizoma seu radix notopterygii, radix paeoniae rubra, radix angelicae pubescentis, camphor, safflower, rosin, herba schizonepetae and liquorice through processing. The traditional Chinese medicine preparation realizes a remarkable curative effect on the frostbite of all degrees and shows noticeable technical advantages such as fast effect, good curative effect, no scar after healing and no toxic or side effects in frostbite treatment.

Description

A kind of Chinese medicine preparation treating cold injury
Technical field
The invention belongs to technical field of Chinese medicine, relate to a kind of Chinese medicine preparation treating cold injury.
Background technology
Cold injury is the body local owing to cold wet effect causes or whole body damage. Skin transient damage can be caused time light, give treatment in time; Permanent disfunction can be caused during weight, specialty treatment need to be carried out. Time serious can threat to life, need to promptly rescue. Doctor trained in Western medicine thinks that the cause of disease of cold injury is: when being in low temperature and moist stimulation when the health long period, will making the blood vessel generation spasm of body surface, therefore blood flow reduces, cause tissue ischemia anoxia, cell sustains damage, and the position that especially far-end of limb blood circulation is poor, such as toe.
Primary disease is similar with " chilblain ", " being frozen rotten swollen skin ulcer " of motherland's medical literature record. As " surgery opens profound " chilblain is recorded: " chilblain is many by its cold, causes and makes pain time at the beginning of appearance brothers swollen, break out pus and blood, meets to warm up and then have a fever. Also there is the people that vigour is weak, have it weak to its cold person ". And for example " General Treatise on the Cause and Symptoms of Diseases " is frozen rotten swollen skin ulcer and waits record: " moon in severe winter, to touch the gas emitting wind and snow severe pathogenic cold, hinder in skin, vim and vigour are stopped up puckery, thus chilblain, glad red pain swells, and just becomes chilblain ". Chilblain has another name called frostbite, freezes chilblain. Many injuring skin skin and flesh because of very cold, coagulation of QI-blood can not be transported to and originator. Its card is more common in the exposure portion such as brothers, auricle, face, and illing skin, first in pale, is gradually shown in livid purple and aobvious erythema lamellar, and conscious burning is itched bitterly, numbness of very then locally scratching where it itches, and ulceration forms skin ulcer, and touching difficulty is more. The traditional Chinese medical science is thought: cold injury system yang-energy does not reach, and multiple sense cold invasion and attack, QI-blood circulation is not smooth, and passages through which vital energy circulates intercepts, coagulation of QI-blood skin. Mainly there is following differentiation of symptoms and signs for classification of syndrome:
1, cold blood stasis card
Zheng Jian mono-anesthesia sends out cool, cold type of pain, and the colour of skin is livid purple or dark red, and swelling is lumpd, or has vesicle, itches, or causalgia, insensitive. Tongue fur is white, or tongue with ecchymosis, deep pulse or thin. Control suitable warming YANG to expel cold, harmonizing yingfen and weifen.
2, cold coagulation heat-transformation card
After disease sees cold injury, local necrosis, sore surface ulcerated is suppurated, and surrounding is red and swollen, and the pain increased, with heating, xerostomia, red tongue, yellow fur, rapid pulse. Control suitable heat-clearing and toxic substances removing, promoting blood circulation and stopping pain.
3, Han Shengyang declines card
Disease is seen and is shivered with cold constantly, extreme cold of the limbs, and curling oneself up is drowsiness, stolidity, acra cold type of pain, pale complexion, pale tongue, and tongue is white, deep-slow pulse. Or unconsciousness, bradykinesia, unconsciousness, extreme cold of the limbs, whole body is stiff, cyanosis of the lips and nails, complexion deashing, and platycoria is panted faint, faint pulse being about to disappear, or all nothings of six kinds of pulses. Controlling and should recuperating depleted YANG and rescuing the patient from collapse admittedly take off, cold expelling is promoted blood circulation.
4, habitual cold injury
Often then sending out dead season in winter, mono-anesthesia's cold type of pain, the colour of skin is livid purple, and swelling is lumpd, or sees pain of itching, insensitive. Companion sees that the tired body of body is tired, and cold physique fear is cold, lustreless complexion, pale tongue, and tongue is white, thready and weak pulse. Suitable invigorating QI and blood, temperature promoting blood circulation.
Summary of the invention
It is an object of the invention to develop a kind of Chinese medicine preparation treating cold injury and preparation method thereof, in order to reach this purpose, the solution of inventor is:
A kind of Chinese medicine preparation treating cold injury, with parts by weight, the Chinese prescription of this Chinese medicine preparation is: Ramulus Cinnamomi 11-34 part, Fructus Jujubae 6-23 part, Cortex Cinnamomi 10-38 part, Radix Astragali 11-40 part, Radix Angelicae Sinensis 8-29 part, Rhizoma Zingiberis Recens 7-24 part, Radix Saposhnikoviae 6-24 part, Fructus Piperis 7-26 part, Radix Angelicae Dahuricae 7-25 part, Fructus Foeniculi 6-18 part, Rhizoma Et Radix Notopterygii 5-17 part, Radix Paeoniae Rubra 6-20 part, Radix Angelicae Pubescentis 6-20 part, Camphora 3-13 part, Flos Carthami 5-17 part, Olibanum 3-10 part, Herba Schizonepetae 8-26 part, Radix Glycyrrhizae 10-30 part.
The preferred prescription proportioning with preferably curative effect out of the present invention is expressed as with weight portion:
Optimum ratio 1: Ramulus Cinnamomi 22 parts, 14 parts of Fructus Jujubae, Cortex Cinnamomi 24 parts, the Radix Astragali 25 parts, Radix Angelicae Sinensis 18 parts, 17 parts of Rhizoma Zingiberis Recens, Radix Saposhnikoviae 14 parts, 15 parts of Fructus Piperis, the Radix Angelicae Dahuricae 15 parts, 12 parts of Fructus Foeniculi, Rhizoma Et Radix Notopterygii 11 parts, Radix Paeoniae Rubra 13 parts, Radix Angelicae Pubescentis 13 parts, Camphora 8 parts, 11 parts of Flos Carthami, Olibanum 6 parts, Herba Schizonepetae 16 parts, 20 parts of Radix Glycyrrhizae.
Optimum ratio 2: Ramulus Cinnamomi 11 parts, 23 parts of Fructus Jujubae, Cortex Cinnamomi 11 parts, the Radix Astragali 39 parts, Radix Angelicae Sinensis 9 parts, 23 parts of Rhizoma Zingiberis Recens, Radix Saposhnikoviae 6 parts, 26 parts of Fructus Piperis, the Radix Angelicae Dahuricae 24 parts, 7 parts of Fructus Foeniculi, Rhizoma Et Radix Notopterygii 6 parts, Radix Paeoniae Rubra 19 parts, Radix Angelicae Pubescentis 7 parts, Camphora 12 parts, 5 parts of Flos Carthami, Olibanum 10 parts, Herba Schizonepetae 8 parts, 30 parts of Radix Glycyrrhizae.
The preparation method of Chinese medicine preparation of the present invention is following steps:
(1), Ramulus Cinnamomi, Fructus Jujubae, Cortex Cinnamomi, the Radix Astragali, Radix Angelicae Sinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Fructus Piperis, the Radix Angelicae Dahuricae, Fructus Foeniculi, Rhizoma Et Radix Notopterygii, Radix Paeoniae Rubra, Radix Angelicae Pubescentis, Camphora, Flos Carthami, Olibanum, Herba Schizonepetae, Radix Glycyrrhizae ingredients are accurately weighed by Chinese prescription of the present invention;
(2), take Camphora pulverizing, grind, cross 70-120 mesh sieve, obtain fine powder a, standby;
(3), take Olibanum, the Radix Astragali, Radix Glycyrrhizae are pulverized respectively, parch, grind, and cross 70-120 mesh sieve, obtain fine powder b, standby;
(4), take Ramulus Cinnamomi, Fructus Jujubae, Cortex Cinnamomi, Radix Angelicae Sinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Fructus Piperis, the Radix Angelicae Dahuricae, Fructus Foeniculi, Rhizoma Et Radix Notopterygii, Radix Paeoniae Rubra, Radix Angelicae Pubescentis, Flos Carthami, Herba Schizonepetae add the distilled water of 4-16 times, soak 5-24 hour, backflow decocts 3 times, each 1-6 hour, filtering, mix 3 filtrates, being evaporated to surveyed relative density when 55 DEG C is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, standby;
(5), by fine powder a, b join in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, it is effective ingredient thick paste;
(6), suitable adjuvant is added, utilize modern general Chinese medicine preparation technology that effective ingredient thick paste is made the finished dosage forms that modern clinic needs, for instance the dosage forms such as powder, unguentum (containing soft extract, ointment, plaster), sublimed preparation, medicated wine, patch, extractum, lozenge, colloid, nail agent, stick, suppository, tincture, spray, membrane.
The primary raw material medical material brief introduction of Chinese medicine preparation of the present invention is as follows:
Ramulus Cinnamomi: this product is the dry twig of canella Cortex Cinnamomi. Acrid in the mouth, sweet, warm in nature; GUIXIN, lung, bladder warp; Diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.
Fructus Jujubae: this product is the dry mature fruit of Rhamnaceae jujube Fructus Jujubae. Sweet in the mouth, warm in nature; Return spleen, stomach warp; Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.
Cortex Cinnamomi: this product is the dry bark of canella Cortex Cinnamomi. Acrid in the mouth, sweet, extremely hot in nature; Return kidney, spleen, the heart, Liver Channel; Mend fire supporing yang, let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow.
The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali. Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.
Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica. Sweet in the mouth, pungent, warm in nature; Return liver, the heart, spleen channel; Replenishing and activating blood, menstruction regulating and pain relieving, loosening bowel to relieve constipation.
Rhizoma Zingiberis Recens: this product is the dry rhizome of zingiber. Acrid in the mouth, hot in nature; Return spleen, stomach, kidney, the heart, lung meridian; Warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant.
Radix Saposhnikoviae: this product is the dry root of umbelliferae Saposhnikovia divaricata. Acrid in the mouth, sweet, warm in nature; Return bladder, liver, spleen channel; Inducing diaphoresis to dispel wind, victory is wet, relieving convulsion.
Fructus Piperis: this product is the dry near ripe of Piperaceae plant Fructus Piperis or mature fruit. Acrid in the mouth, hot in nature; Return stomach, large intestine channel; Warming spleen and stomach for dispelling cold, the therapeutic method to keep the adverse QI flowing downwards, expectorant.
The Radix Angelicae Dahuricae: this product is the dry root of the umbellate form section plant Radix Angelicae Dahuricae or Radix angelicae dahuricae. Acrid in the mouth, warm in nature; Return stomach, large intestine, lung meridian; Dissipate wind dehumidifying, sensible pain relieving, detumescence and apocenosis.
Fructus Foeniculi: for the fruit of samphire Fructus Foeniculi. Acrid in the mouth, warm in nature; Enter kidney, bladder, stomach warp; Warming kidney for dispelling cold, regulating the stomach to normalize QI.
Rhizoma Et Radix Notopterygii: this product is dry rhizome and the root of samphire Rhizoma Et Radix Notopterygii (back of the body wing celery) or Radix et Rhizoma Notopterygii. Acrid in the mouth, hardship, warm in nature; Return bladder, kidney channel; Cold expelling, dispels the wind, dehumidifying, pain relieving.
Radix Paeoniae Rubra: this product is ranunculaceae plant Radix Paeoniae or the dry root of river Radix Paeoniae Rubra. Bitter in the mouth, cold nature; Return Liver Channel; Clearing away heat and cooling blood, eliminating stasis to stop pain.
Radix Angelicae Pubescentis: this product is the dry root of samphire Angelica pubescens. Acrid in the mouth, hardship, slightly warm in nature; Return kidney, bladder warp; Expelling wind and removing dampness, numbness relieving and pain relieving.
Camphora: for the root of canella Camphor tree, dry, branch, leaf, through the crystalline particulate that refinement is made. Acrid in the mouth, hot in nature; GUIXIN, spleen channel; Orifice opening, qi stagnation removing, ward off foul, killing parasites for relieving itching, reducing swelling and alleviating pain.
Flos Carthami: call red blue flower, thorn Flos Carthami, Compositae, Flos Carthami platymiscium. Acrid in the mouth, warm in nature; Enter the heart, Liver Channel; Promoting blood circulation to restore menstrual flow, blood stasis removing pain relieving.
Olibanum: Burseraceae Boswellia carterii platymiscium Boswellia carterii, medicine glue XIANGSHU and wild Boswellia carterii etc., is used as medicine with the oleo-gum-resin that its trunk skin zone wound oozes out. Acrid in the mouth is bitter, warm in nature; Enter the heart, liver, spleen channel; Regulating qi and activating blood, analgesic therapy, chase after poison.
Herba Schizonepetae: this product is the dry aerial parts of labiate Herba Schizonepetae. Acrid in the mouth, slightly warm in nature; Return lung, Liver Channel; Induce sweat scattered wind, rash.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.. Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of the Chinese prescription of Chinese medicine preparation of the present invention:
This Chinese prescription be with Ramulus Cinnamomi, Cortex Cinnamomi, the Radix Astragali, Radix Glycyrrhizae, Rhizoma Zingiberis Recens, when being classified as monarch drug, promoting the flow of QI-blood by warming the meridian, dispersing cold for relieving pain, expelling pus and promoting granulation, relieving spasm to stop pain, warming spleen and stomach for dispelling cold, replenishing and activating blood; With Herba Schizonepetae, Radix Saposhnikoviae, Fructus Jujubae, Fructus Piperis, radix angelicae is used as the minister materials medicine, the scattered wind that induces sweat, victory wet relieving convulsion, invigorating the spleen and replenishing QI, warming spleen and stomach for dispelling cold, detumescence and apocenosis; With Radix Paeoniae Rubra, Radix Angelicae Pubescentis, Fructus Foeniculi, Camphora for adjuvant drug, eliminating stasis to stop pain, expelling wind and removing dampness, warming kidney for dispelling cold, repellent antipruritic; With Rhizoma Et Radix Notopterygii, Flos Carthami, Olibanum for making medicine, removing damp and stopping pain, promoting blood circulation to restore menstrual flow, analgesic therapy chase after poison; The all medicines of monarch coordinate, YIN and YANG balancing, the exterior and the interior is helped each other, complement each other, thus reach promoting the flow of QI-blood by warming the meridian, dispersing cold for relieving pain, expelling pus and promoting granulation, relieving spasm to stop pain, warming spleen and stomach for dispelling cold, replenishing and activating blood, the scattered wind that induces sweat, detumescence and apocenosis, analgesic therapy chase after the effects such as poison, and cold injury at different levels all have very significant curative effect.
Compared with prior art, Chinese medicine preparation of the present invention treatment cold injury has the technical advantage that it is huge:
1, instant effect, good effect, more after without cicatrix, have no side effect;
2, preparation process is simple and easy to do, preparation raw material sources is sufficient and cheap, the efficacy stability of preparation and general adaptability good, be appropriate to produce and convert, it is possible to create bigger social value.
Therefore, the present invention is also claimed the application in the medicine of preparation treatment cold injury of the above-mentioned Chinese medicine preparation.
Detailed description of the invention
Embodiment 1
Ointment is produced with the preferred process parameter of the preferred prescription proportioning 1 of the present invention and preparation method:
(1), Ramulus Cinnamomi 2200g, Fructus Jujubae 1400g, Cortex Cinnamomi 2400g, Radix Astragali 2500g, Radix Angelicae Sinensis 1800g, Rhizoma Zingiberis Recens 1700g, Radix Saposhnikoviae 1400g, Fructus Piperis 1500g, Radix Angelicae Dahuricae 1500g, Fructus Foeniculi 1200g, Rhizoma Et Radix Notopterygii 1100g, Radix Paeoniae Rubra 1300g, Radix Angelicae Pubescentis 1300g, Camphora 800g, Flos Carthami 1100g, Olibanum 600g, Herba Schizonepetae 1600g, Radix Glycyrrhizae 2000g are accurately weighed by Chinese prescription of the present invention;
(2), take Camphora pulverizing, grind, cross 80 mesh sieves, obtain fine powder a, standby;
(3), take Olibanum, the Radix Astragali, Radix Glycyrrhizae are pulverized respectively, parch, grind, and cross 80 mesh sieves, obtain fine powder b, standby;
(4), take Ramulus Cinnamomi, Fructus Jujubae, Cortex Cinnamomi, Radix Angelicae Sinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Fructus Piperis, the Radix Angelicae Dahuricae, Fructus Foeniculi, Rhizoma Et Radix Notopterygii, Radix Paeoniae Rubra, Radix Angelicae Pubescentis, Flos Carthami, Herba Schizonepetae add the distilled water of 12 times, soak 10 hours, backflow decocts 3 times, each 3 hours, filtering, mix 3 filtrates, being evaporated to surveyed relative density when 55 DEG C is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, standby;
(5), by fine powder a, b join in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, it is effective ingredient thick paste;
(6), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology that effective ingredient thick paste is made ointment, specification is 0.31g crude drug/g ointment.
Embodiment 2
Ointment is produced with the preferred process parameter of the preferred prescription proportioning 2 of the present invention and preparation method:
(1), Ramulus Cinnamomi 1100g, Fructus Jujubae 2300g, Cortex Cinnamomi 1100g, Radix Astragali 3900g, Radix Angelicae Sinensis 900g, Rhizoma Zingiberis Recens 2300g, Radix Saposhnikoviae 600g, Fructus Piperis 2600g, Radix Angelicae Dahuricae 2400g, Fructus Foeniculi 700g, Rhizoma Et Radix Notopterygii 600g, Radix Paeoniae Rubra 1900g, Radix Angelicae Pubescentis 700g, Camphora 1200g, Flos Carthami 500g, Olibanum 1000g, Herba Schizonepetae 800g, Radix Glycyrrhizae 3000g are accurately weighed by Chinese prescription of the present invention;
(2), take Camphora pulverizing, grind, cross 80 mesh sieves, obtain fine powder a, standby;
(3), take Olibanum, the Radix Astragali, Radix Glycyrrhizae are pulverized respectively, parch, grind, and cross 80 mesh sieves, obtain fine powder b, standby;
(4), take Ramulus Cinnamomi, Fructus Jujubae, Cortex Cinnamomi, Radix Angelicae Sinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Fructus Piperis, the Radix Angelicae Dahuricae, Fructus Foeniculi, Rhizoma Et Radix Notopterygii, Radix Paeoniae Rubra, Radix Angelicae Pubescentis, Flos Carthami, Herba Schizonepetae add the distilled water of 12 times, soak 10 hours, backflow decocts 3 times, each 3 hours, filtering, mix 3 filtrates, being evaporated to surveyed relative density when 55 DEG C is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, standby;
(5), by fine powder a, b join in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, it is effective ingredient thick paste;
(6), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology that effective ingredient thick paste is made ointment, specification is 0.31g crude drug/g ointment.
Embodiment 3
Ointment is produced with the preferred process parameter of the maximum within the scope of prescription of the present invention and preparation method:
(1), Ramulus Cinnamomi 3400g, Fructus Jujubae 2300g, Cortex Cinnamomi 3800g, Radix Astragali 4000g, Radix Angelicae Sinensis 2900g, Rhizoma Zingiberis Recens 2400g, Radix Saposhnikoviae 2400g, Fructus Piperis 2600g, Radix Angelicae Dahuricae 2500g, Fructus Foeniculi 1800g, Rhizoma Et Radix Notopterygii 1700g, Radix Paeoniae Rubra 2000g, Radix Angelicae Pubescentis 2000g, Camphora 1300g, Flos Carthami 1700g, Olibanum 1000g, Herba Schizonepetae 2600g, Radix Glycyrrhizae 3000g are accurately weighed by Chinese prescription of the present invention;
(2), take Camphora pulverizing, grind, cross 80 mesh sieves, obtain fine powder a, standby;
(3), take Olibanum, the Radix Astragali, Radix Glycyrrhizae are pulverized respectively, parch, grind, and cross 80 mesh sieves, obtain fine powder b, standby;
(4), take Ramulus Cinnamomi, Fructus Jujubae, Cortex Cinnamomi, Radix Angelicae Sinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Fructus Piperis, the Radix Angelicae Dahuricae, Fructus Foeniculi, Rhizoma Et Radix Notopterygii, Radix Paeoniae Rubra, Radix Angelicae Pubescentis, Flos Carthami, Herba Schizonepetae add the distilled water of 12 times, soak 10 hours, backflow decocts 3 times, each 3 hours, filtering, mix 3 filtrates, being evaporated to surveyed relative density when 55 DEG C is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, standby;
(5), by fine powder a, b join in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, it is effective ingredient thick paste;
(6), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology that effective ingredient thick paste is made ointment, specification is 0.31g crude drug/g ointment.
Embodiment 4
Ointment is produced with the preferred process parameter of the minima within the scope of prescription of the present invention and preparation method:
(1), Ramulus Cinnamomi 1100g, Fructus Jujubae 600g, Cortex Cinnamomi 1000g, Radix Astragali 1100g, Radix Angelicae Sinensis 800g, Rhizoma Zingiberis Recens 700g, Radix Saposhnikoviae 600g, Fructus Piperis 700g, Radix Angelicae Dahuricae 700g, Fructus Foeniculi 600g, Rhizoma Et Radix Notopterygii 500g, Radix Paeoniae Rubra 600g, Radix Angelicae Pubescentis 600g, Camphora 300g, Flos Carthami 500g, Olibanum 300g, Herba Schizonepetae 800g, Radix Glycyrrhizae 1000g are accurately weighed by Chinese prescription of the present invention;
(2), take Camphora pulverizing, grind, cross 80 mesh sieves, obtain fine powder a, standby;
(3), take Olibanum, the Radix Astragali, Radix Glycyrrhizae are pulverized respectively, parch, grind, and cross 80 mesh sieves, obtain fine powder b, standby;
(4), take Ramulus Cinnamomi, Fructus Jujubae, Cortex Cinnamomi, Radix Angelicae Sinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Fructus Piperis, the Radix Angelicae Dahuricae, Fructus Foeniculi, Rhizoma Et Radix Notopterygii, Radix Paeoniae Rubra, Radix Angelicae Pubescentis, Flos Carthami, Herba Schizonepetae add the distilled water of 12 times, soak 10 hours, backflow decocts 3 times, each 3 hours, filtering, mix 3 filtrates, being evaporated to surveyed relative density when 55 DEG C is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, standby;
(5), by fine powder a, b join in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, it is effective ingredient thick paste;
(6), adding suitable adjuvant, utilize modern general Chinese medicine preparation technology that effective ingredient thick paste is made ointment, specification is 0.31g crude drug/g ointment.
Embodiment 5
The toxicity test of Chinese medicine preparation of the present invention
1, skin irritation test
(1), Experimental agents: the ointment that the embodiment of the present invention 1, embodiment 2 produce, specification is 0.31g crude drug/g ointment.
(2), experimental technique:
Taking healthy guinea pig 36, be randomly divided into 3 groups, often depilatory is uniformly coated with, makes unhairing scope about 20 square centimeters by group 12 by guinea pig back spinal column both sides. Clean depilatory returns cage to observe 24 hours, 2 groups of Cavia porcelluss are coated with traditional Chinese herb medicine 2g of the present invention, 4g and 8g respectively, respectively containing crude drug 0.62g, 1.24g and 2.48g, matched group is coated with the every twice-daily of solvent 0.8ml, continuous one week, after experiment terminates, being put to death by Cavia porcellus, the heart, liver, kidney and depilation skin do pathological examination.
(3), result
Above-mentioned 2 groups of medication Cavia porcellus trunks depilation district, having no local skin has edema, hyperemia, erythema, petechia and ulcer. Medication group Cavia porcellus chroma of hair, ingest, the matched group no significant difference such as extremity are movable, histopathologic examination, the administration group heart, liver, kidney and depilation skin compare also no significant difference with compareing word. Result is pointed out, and Chinese medicine preparation of the present invention, without local irritant effect, also has no general toxicity performance. Show that Chinese medicine for external application of the present invention uses safety.
2, animal acute toxicity test research:
Ointment of the present invention is through trial test, it is impossible to measure LD50, therefore measure maximum dosage-feeding. Adopting rectal delivery, the maximum dosage-feeding on the one recording mice is that 94.3g/kg(is in crude drug), it is about 428.6 times (people is in 60kg) of anthropomorphic clinical research on maximum utilized quantity (people's clinic research on maximum utilized quantity is 0.22g crude drug/kg/d). The equal Continuous Observation of laboratory animal one week, its outward appearance sign, the mental status, diet, drinking-water, feces etc. are showed no obvious abnormalities. When experiment terminates, all healthy survival of animal, body weight increases.
3, long-term toxicity test for animals research:
Experimental design medicine of the present invention is high, in, low dose group, Matrix controls group and blank group, adopt rectal delivery to give rat, and dosage is 17.6g/kg respectively, 13.2g/kg with 8.8g/kg(is in crude drug), be equivalent to intend the 80 of clinical patient research on maximum utilized quantity, 60 and 40 times, successive administration 3 months, in administration process, the body weight of each administration group and matrix group rat, dietary amount, outward appearance sign, behavioral activity, the mental status, hair color, feces character compares with blank group, no significant difference (P > 0.05), the weight of animals increasing value and Main Organ Coefficients and blank group comparing difference not notable (P > 0.05), hematology and blood parameters check that result administration group compares without significant difference (P > 0.05) with blank group, other indexs and blank comparing difference not notable (P > 0.05), administration phase and convalescent period histological examination high dose group animal main organs compare with blank group and have no notable difference, have no slowness toxicity and occur.
By above experiment, illustrate that Chinese medicine ointment clinical application of the present invention is safe.
Embodiment 6
Antiinflammatory action is tested
(1), impact on mice ear: take mice 40, it is randomly divided into 4 groups, every day is administered once, kibe ointment group dosage is by adult's clinical dosage external application administration, embodiment 1 medicine group, embodiment 2 drug component Yong embodiment 1, the made ointment of embodiment 2 (specification is 0.31g crude drug/g ointment), by the positive and negative surface of auris dextra normally making consumption smear mice, successive administration 7 days, after last is administered 1 hour, in the positive and negative topcoating dimethylbenzene 0.05ml of mouse right ear, to after dimethylbenzene 2 hours, put to death animal, cut ear, auricle is swept away in corresponding site 8mm steel drift, weigh, with the difference of left and right ear weight for swelling degree, result is in Table 1.
Table 1 xylol cause mice ear impact (, n=10)
Note: compare with saline control group, * * P < 0.01; Compare with kibe ointment group,��P < 0.05.
(2), the impact on mice granuloma induced by implantation of cotton pellets: implant each 1 of 5mg sterilized cotton ball in oxter, mice left and right, packet administration, kibe ointment group dosage is by adult's quantity external application administration, embodiment 1 medicine group, embodiment 2 drug component not with embodiment 1, the made ointment of embodiment 2 by the affected part normally making consumption smear mice, every day 1 time, totally 7 days, animal is put to death after last is administered 1 hour, taking granuloma induced by implantation of cotton pellets, weigh (weight in wet base), result is in Table 2.
Table 2 on the mice granulomatous impact of cotton balls number (, n=10)
Note: compare with saline control group, * * P < 0.01; Compare with kibe ointment group,��P < 0.05.
(3), impact on inflammatory exudate PGE content: take mice 40, it is randomly divided into 4 groups, every day is administered once, kibe ointment group dosage is by adult's quantity external application administration, embodiment 1 medicine group, embodiment 2 drug component Yong embodiment 1, the made ointment of embodiment 2 is by the legs and feet surface normally making consumption smear mice, it is administered 7 days, after last is administered 1 hour, in left sufficient plantar aponeurosis hemostasis 1% carrageenin 0.1ml/ only, after 3 hours, swollen foot is cut from Mus left hind joint, weigh, peeling shreds, steep 40min in 5ml normal saline, take supernatant 0.5ml, add 2ml10.5NKOH methanol solution, isomerization 20min in 50 DEG C of water-baths, add methanol dilution to 20ml, its optical density is surveyed with 751 type spectrophotometer wavelength 278nm, try to achieve PGE total content, in Table 3.
Table 3 on the impact of inflammatory exudate PGE content (, n=10)
Note: compare with saline control group, * * P < 0.01; Compare with kibe ointment group,��P < 0.05.
Being shown by the experimental result of table 1-3, medicine group of the present invention and kibe ointment medicine group all have good antiinflammatory action in above-mentioned antiinflammatory experiment, compare with normal saline group, and both has reached the difference of pole significance; Comparing with kibe ointment group, medicine group of the present invention is respectively provided with, on antiinflammatory experiments such as the impact of mice ear, granuloma induced by implantation of cotton pellets, inflammatory exudate PGE content, the effect that significance difference is different in nature; Above result of the test is pointed out: medicine group of the present invention has good antiinflammatory action, and its action effect is significantly better than kibe ointment.
Embodiment 7
The clinical trial of Chinese medicine preparation of the present invention
1, physical data
Cold injury patient 246 example is collected in this clinical trial altogether, age 16-56 year, wherein male 102 examples, female 144 example; All patients are divided into matched group by sex, age, cold injury rank etc., test 1 group and 2 groups of three groups of test, make these three group possess the comparability on statistical significance.
2, test medication
Comparison medicine: kibe ointment, the quasi-word H42020886 of traditional Chinese medicines, batch: 01320031077, manufacturer: Hubei Ke Tian pharmaceutcal corporation, Ltd;
Investigational agent: test 1 group of ointment being the embodiment of the present invention 1 and producing, specification is 0.31g crude drug/g ointment; Testing 2 groups of ointments being the embodiment of the present invention 2 and producing, specification is 0.31g crude drug/g ointment.
3, test method and result
The all patients of matched group smear comparison medicine, every day 2 times in affected part, cover affected part every time and are as the criterion, 8 hours, interval; The all patients of test group smear investigational agent, every day 2 times in affected part, cover affected part every time and are as the criterion, 8 hours, interval; Within one week, being a course for the treatment of, all patients treat 4 courses for the treatment of continuously. Result is added up as shown in table 4 after terminating by treatment.
Table 4 test data statistical analysis table
4, conclusion
Table 4 result of the test shows, Chinese medicine preparation of the present invention has, compared with comparison medicine, advantage for the treatment of very significantly, and cure rate is up to 64.6%, and total effective rate is higher 25.6 percentage points than comparison medicine. Therefore, compared with prior art, Chinese medicine preparation of the present invention has very significant technical advantage, achieves breakthrough technical progress and scientific progress in its field, and its creativeness should be not out in the cold.

Claims (3)

1. the Chinese medicine preparation treating cold injury, it is characterized in that, with parts by weight, the Chinese prescription of described Chinese medicine preparation is: Ramulus Cinnamomi 11-34 part, Fructus Jujubae 6-23 part, Cortex Cinnamomi 10-38 part, Radix Astragali 11-40 part, Radix Angelicae Sinensis 8-29 part, Rhizoma Zingiberis Recens 7-24 part, Radix Saposhnikoviae 6-24 part, Fructus Piperis 7-26 part, Radix Angelicae Dahuricae 7-25 part, Fructus Foeniculi 6-18 part, Rhizoma Et Radix Notopterygii 5-17 part, Radix Paeoniae Rubra 6-20 part, Radix Angelicae Pubescentis 6-20 part, Camphora 3-13 part, Flos Carthami 5-17 part, Olibanum 3-10 part, Herba Schizonepetae 8-26 part, Radix Glycyrrhizae 10-30 part.
2. a kind of Chinese medicine preparation treating cold injury as claimed in claim 1, it is characterized in that, with parts by weight, the Chinese prescription of described Chinese medicine preparation is: Ramulus Cinnamomi 22 parts, 14 parts of Fructus Jujubae, Cortex Cinnamomi 24 parts, the Radix Astragali 25 parts, Radix Angelicae Sinensis 18 parts, 17 parts of Rhizoma Zingiberis Recens, Radix Saposhnikoviae 14 parts, 15 parts of Fructus Piperis, the Radix Angelicae Dahuricae 15 parts, 12 parts of Fructus Foeniculi, Rhizoma Et Radix Notopterygii 11 parts, Radix Paeoniae Rubra 13 parts, Radix Angelicae Pubescentis 13 parts, Camphora 8 parts, 11 parts of Flos Carthami, Olibanum 6 parts, Herba Schizonepetae 16 parts, 20 parts of Radix Glycyrrhizae.
3. a kind of Chinese medicine preparation treating cold injury as claimed in claim 1 or 2, it is characterised in that: the dosage form of described Chinese medicine preparation is powder, unguentum, sublimed preparation, medicated wine, patch, extractum, lozenge, colloid, nail agent, stick, suppository, tincture, spray or membrane.
CN201610049667.XA 2016-01-26 2016-01-26 Traditional Chinese medicine preparation for treating frostbite Withdrawn CN105617328A (en)

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Application publication date: 20160601