CN105497861A - Method for preparing traditional Chinese medicine preparation for treating cold injuries - Google Patents
Method for preparing traditional Chinese medicine preparation for treating cold injuries Download PDFInfo
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- A61K31/12—Ketones
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Abstract
The invention discloses a method for preparing a traditional Chinese medicine preparation for treating cold injuries and belongs to the technical field of traditional Chinese medicine. The preparation method includes the steps that all medicinal materials are accurately weighed according to the traditional Chinese medicine formulation; camphor is taken, smashed and ground to obtain fine powder a; olibanum, milkvetch roots and liquorice roots are taken, smashed, stir-fried and ground to obtain fine powder b; cassia twigs, Chinese dates, cinnamon, radix angelica sinensis, ginger, divaricate saposhnikovia roots, pepper, angelica roots, fennel, notopterygium roots, radix paeoniae rubra, radix angelicae pubescentis, safflower and fineleaf schizonepeta herb are subjected to water extraction and concentrated to obtain traditional Chinese medicine concentrated liquor; the fine powder a and the fine powder b are added to the traditional Chinese medicine concentrated liquor and mixed to be even, effective ingredient thick paste is obtained, a proper quantity of auxiliary materials is added, and the finished preparation is prepared. The preparation method is easy, convenient and practical, and the preparation is stable in medicine effect, good in general adaptability and suitable for production transformation. In addition, the traditional Chinese medicine preparation prepared through the preparation method has a very remarkable treatment effect on all hierarchic cold injuries and has the remarkable technical advantages of being rapid in effect taking, good in treatment effect, free of scars after healing, free of toxic and side effects and the like on the aspect of treating the cold injuries.
Description
Technical field
The invention belongs to technical field of Chinese medicine, relate to a kind of method preparing the Chinese medicine preparation for the treatment of cold injury.
Background technology
Cold injury is body local because cold wet effect causes or whole body damage.Skin transient damage can be caused time light, give treatment in time; Can permanent disfunction be caused time heavy, specialty treatment need be carried out.Can threat to life time serious, need promptly rescue.Doctor trained in Western medicine thinks that the cause of disease of cold injury is: when the health long period is in low temperature and moist stimulation, will make 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, as toe.
" chilblain ", " being frozen rotten swollen skin ulcer " that primary disease and motherland's medical literature are recorded is similar.As " surgery opens profound " chilblain is recorded: " chilblain is subject to it cold, causes and makes appearance brothers first pain time swell, break out pus and blood, meet to warm up and then has a fever.Also have the people that vigour is weak, its cold person not resistance to has it ".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, touch the gas emitting wind and snow severe pathogenic cold, hinder in skin, vim and vigour are stopped up puckery, thus chilblain, and glad red pain swells, and just becomes chilblain ".Chilblain has another name called frostbite, freezes chilblain.How because very cold injures skin skin and flesh, 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 more.The traditional Chinese medical science is thought: cold injury system yang-energy does not reach, the cold invasion and attack of multiple sense, and QI-blood circulation is not smooth, and passages through which vital energy circulates intercepts, coagulation of QI-blood skin.Mainly contain 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.Control 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 send 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, warm promoting blood circulation.
Summary of the invention
The object of the invention is a kind of Chinese medicine preparation for the treatment of cold injury of exploitation and preparation method thereof, in order to reach this object, the solution of inventor is:
A kind of Chinese medicine preparation for the treatment of 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 better curative effect out of the present invention is expressed as with weight portion:
Optimum ratio 1: Ramulus Cinnamomi 22 parts, 14 parts, Fructus Jujubae, Cortex Cinnamomi 24 parts, the Radix Astragali 25 parts, Radix Angelicae Sinensis 18 parts, 17 parts, Rhizoma Zingiberis Recens, Radix Saposhnikoviae 14 parts, 15 parts, Fructus Piperis, the Radix Angelicae Dahuricae 15 parts, 12 parts, Fructus Foeniculi, Rhizoma Et Radix Notopterygii 11 parts, Radix Paeoniae Rubra 13 parts, Radix Angelicae Pubescentis 13 parts, Camphora 8 parts, 11 parts, Flos Carthami, Olibanum 6 parts, Herba Schizonepetae 16 parts, 20 parts, Radix Glycyrrhizae.
Optimum ratio 2: Ramulus Cinnamomi 11 parts, 23 parts, Fructus Jujubae, Cortex Cinnamomi 11 parts, the Radix Astragali 39 parts, Radix Angelicae Sinensis 9 parts, 23 parts, Rhizoma Zingiberis Recens, Radix Saposhnikoviae 6 parts, 26 parts, Fructus Piperis, the Radix Angelicae Dahuricae 24 parts, 7 parts, Fructus Foeniculi, Rhizoma Et Radix Notopterygii 6 parts, Radix Paeoniae Rubra 19 parts, Radix Angelicae Pubescentis 7 parts, Camphora 12 parts, 5 parts, Flos Carthami, Olibanum 10 parts, Herba Schizonepetae 8 parts, 30 parts, 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 is accurately taken by Chinese prescription of the present invention;
(2), get Camphora pulverizing, grinding, cross 70-120 mesh sieve, obtain fine powder a, for subsequent use;
(3), get Olibanum, the Radix Astragali, Radix Glycyrrhizae pulverize respectively, parch, grinding, crosses 70-120 mesh sieve, obtains fine powder b, for subsequent use;
(4), get 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 4-16 distilled water doubly, soak 5-24 hour, backflow decoction 3 times, each 1-6 hour, filter, mix 3 filtrates, when being evaporated to 55 DEG C, relative density of surveying is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, for subsequent use;
(5), fine powder a, b are joined in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, is effective ingredient thick paste;
(6), suitable adjuvant is added, modern general Chinese medicine preparation technology is utilized effective ingredient thick paste to be made the finished dosage forms of modern clinic needs, the dosage forms such as 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, urinary bladder channel; 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; Enrich blood and invigorate blood circulation, 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 nearly ripe or mature fruit of the drying of Piperaceae plant Fructus Piperis.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; Loose wind dehumidifying, understand things pain-stopping, detumescence and apocenosis.
Fructus Foeniculi: be 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 the dry root of ranunculaceae plant Radix Paeoniae or 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, urinary bladder channel; Expelling wind and removing dampness, numbness relieving and pain relieving.
Camphora: be root, dry, branch, the leaf of canella Camphor tree, through refining the crystalline particulate made.Acrid in the mouth, hot in nature; GUIXIN, spleen channel; Orifice opening, qi stagnation removing, wards off foul, killing parasites for relieving itching, reducing swelling and alleviating pain.
Flos Carthami: call red indigo plant 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, chases 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 loose 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 is 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, enriches blood and invigorating blood circulation; With Herba Schizonepetae, Radix Saposhnikoviae, Fructus Jujubae, Fructus Piperis, the Radix Angelicae Dahuricae for ministerial drug, the wet relieving convulsion of the loose wind that induces sweat, victory, 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, enrich blood invigorate blood circulation, the loose wind that induces sweat, detumescence and apocenosis, analgesic therapy chase after the effects such as poison, all has very significant curative effect to cold injury at different levels.
Compared with prior art, Chinese medicine preparation of the present invention treats the technical advantage that cold injury has it huge:
1, instant effect, good effect, more after without cicatrix, have no side effect;
2, sufficient and cheap, the preparation of simple and easy to do, the preparation raw material sources of preparation process efficacy stability and general adaptability is good, be applicable to carrying out productions conversion, larger social value can be created.
Therefore, the present invention's also application of claimed above-mentioned Chinese medicine preparation in the medicine of preparation treatment cold injury.
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 is accurately taken by Chinese prescription of the present invention;
(2), get Camphora pulverizing, grinding, cross 80 mesh sieves, obtain fine powder a, for subsequent use;
(3), get Olibanum, the Radix Astragali, Radix Glycyrrhizae pulverize respectively, parch, grinding, crosses 80 mesh sieves, obtains fine powder b, for subsequent use;
(4), get 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 decoction 3 times, each 3 hours, filter, mix 3 filtrates, when being evaporated to 55 DEG C, relative density of surveying is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, for subsequent use;
(5), fine powder a, b are joined in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, is effective ingredient thick paste;
(6), add 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 is accurately taken by Chinese prescription of the present invention;
(2), get Camphora pulverizing, grinding, cross 80 mesh sieves, obtain fine powder a, for subsequent use;
(3), get Olibanum, the Radix Astragali, Radix Glycyrrhizae pulverize respectively, parch, grinding, crosses 80 mesh sieves, obtains fine powder b, for subsequent use;
(4), get 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 decoction 3 times, each 3 hours, filter, mix 3 filtrates, when being evaporated to 55 DEG C, relative density of surveying is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, for subsequent use;
(5), fine powder a, b are joined in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, is effective ingredient thick paste;
(6), add 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 is accurately taken by Chinese prescription of the present invention;
(2), get Camphora pulverizing, grinding, cross 80 mesh sieves, obtain fine powder a, for subsequent use;
(3), get Olibanum, the Radix Astragali, Radix Glycyrrhizae pulverize respectively, parch, grinding, crosses 80 mesh sieves, obtains fine powder b, for subsequent use;
(4), get 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 decoction 3 times, each 3 hours, filter, mix 3 filtrates, when being evaporated to 55 DEG C, relative density of surveying is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, for subsequent use;
(5), fine powder a, b are joined in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, is effective ingredient thick paste;
(6), add 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 is accurately taken by Chinese prescription of the present invention;
(2), get Camphora pulverizing, grinding, cross 80 mesh sieves, obtain fine powder a, for subsequent use;
(3), get Olibanum, the Radix Astragali, Radix Glycyrrhizae pulverize respectively, parch, grinding, crosses 80 mesh sieves, obtains fine powder b, for subsequent use;
(4), get 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 decoction 3 times, each 3 hours, filter, mix 3 filtrates, when being evaporated to 55 DEG C, relative density of surveying is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, for subsequent use;
(5), fine powder a, b are joined in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, is effective ingredient thick paste;
(6), add 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 are produced, specification is 0.31g crude drug/g ointment.
(2), experimental technique:
Get healthy guinea pig 36, be divided into 3 groups at random, often organize 12, depilatory is evenly coated by guinea pig back spinal column both sides, makes unhairing scope about 20 square centimeters.Clean depilatory returns cage to observe 24 hours, 2 groups of Cavia porcelluss are coated with traditional Chinese herb medicine 2g, 4g and 8g of the present invention 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, 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 with contrast word more also no significant difference.Result is pointed out, and Chinese medicine preparation of the present invention, without local irritant effect, also has no general toxicity performance.Show Chinese medicine for external application use safety of the present invention.
2, animal acute toxicity test research:
Ointment of the present invention, through trial test, can not measure LD
50, therefore measure maximum dosage-feeding.Adopt rectal delivery, the maximum dosage-feeding on the one recording mice is that 94.3g/kg(is in crude drug), be about 428.6 times (people is in 60kg) of anthropomorphic clinical research on maximum utilized quantity (the clinical research on maximum utilized quantity of people 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.At the end of experiment, 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, dosage is respectively 17.6g/kg, 13.2g/kg and 8.8g/kg(is in crude drug), be equivalent to intend 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 are not significantly (P > 0.05), hematology and blood parameters check result administration group compare without significant difference (P > 0.05) with blank group, other indexs and blank comparing difference are not significantly (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: get mice 40, be divided into 4 groups at random, 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 does not use embodiment 1, the made ointment of embodiment 2 (specification is 0.31g crude drug/g ointment), the positive and negative surface of auris dextra of mice is smeared by normal use amount, successive administration 7 days, in last administration after 1 hour, dimethylbenzene 0.05ml is coated with in mouse right ear positive and negative, 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, the results are shown 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), on the impact of mice granuloma induced by implantation of cotton pellets: implant each 1 of 5mg sterilized cotton ball in oxter, mice left and right, grouping administration, kibe ointment group dosage is by adult's quantity external application administration, embodiment 1 medicine group, embodiment 2 drug component do not smear the affected part of mice by normal use amount with embodiment 1, the made ointment of embodiment 2, every day 1 time, totally 7 days, animal is put to death after 1 hour in last administration, get granuloma induced by implantation of cotton pellets, weigh (weight in wet base), the results are shown in Table 2.
Table 2 on the granulomatous impact of mice 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: get mice 40, be divided into 4 groups at random, 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 does not use embodiment 1, the made ointment of embodiment 2 smears the legs and feet surface of mice by normal use amount, administration 7 days, in last administration after 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, get supernatant 0.5ml, add 2ml10.5NKOH methanol solution, isomerization 20min in 50 DEG C of water-baths, add methanol dilution again 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.
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 the experiment of above-mentioned antiinflammatory, and compare with normal saline group, the two all reaches the difference of pole significance; Compare with kibe ointment group, medicine group of the present invention all has the effect of the significance difference opposite sex in the antiinflammatory experiments such as the impact on mice ear, granuloma induced by implantation of cotton pellets, inflammatory exudate PGE content; Above result of the test prompting: 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
This clinical trial collect altogether cold injury patient 246 example, age 16-56 year, wherein man 102 example, female 144 example; All patients are divided into matched group by sex, age, cold injury rank etc., test 1 group and test 2 groups of three groups, make these three groups possess comparability on statistical significance.
2, medication is tested
Contrast medicine: kibe ointment, the accurate word H42020886 of traditional Chinese medicines, batch: 01320031077, manufacturer: Hubei Ke Tian pharmaceutcal corporation, Ltd;
Investigational agent: test 1 group of ointment produced for the embodiment of the present invention 1, specification is 0.31g crude drug/g ointment; Test 2 groups of ointments produced for the embodiment of the present invention 2, specification is 0.31g crude drug/g ointment.
3, test method and result
The all patients of matched group smear contrast medicine in affected part, every day 2 times, and each affected part that covers is as the criterion, 8 hours, interval; The all patients of test group smear investigational agent in affected part, every day 2 times, and each affected part that covers is as the criterion, 8 hours, interval; Within one week, be a course for the treatment of, all patients treat 4 courses for the treatment of continuously.After treatment terminates, result is added up as shown in table 4.
Table 4 test data statistical analysis table
4, conclusion
Table 4 result of the test shows, and Chinese medicine preparation of the present invention has compared with contrast medicine treats advantage very significantly, and cure rate is up to 64.6%, and total effective rate is higher 25.6 percentage points than contrast 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. prepare a method for the Chinese medicine preparation for the treatment of cold injury, it is characterized in that, described preparation method comprises the 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 is accurately taken by Chinese prescription;
(2), get Camphora pulverizing, grinding, cross 70-120 mesh sieve, obtain fine powder a, for subsequent use;
(3), get Olibanum, the Radix Astragali, Radix Glycyrrhizae pulverize respectively, parch, grinding, crosses 70-120 mesh sieve, obtains fine powder b, for subsequent use;
(4), get 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 4-16 distilled water doubly, soak 5-24 hour, backflow decoction 3 times, each 1-6 hour, filter, mix 3 filtrates, when being evaporated to 55 DEG C, relative density of surveying is 1.25-1.30, obtain the concentrated liquid of tradition Chinese medicine, for subsequent use;
(5), fine powder a, b are joined in the concentrated liquid of tradition Chinese medicine of step (4), mix homogeneously, is effective ingredient thick paste;
(6), add suitable adjuvant, utilize modern general Chinese medicine preparation technology effective ingredient thick paste to be made the finished dosage forms of modern clinic needs.
2. a kind of method of Chinese medicine preparation preparing treatment 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 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.
3. a kind of method of Chinese medicine preparation preparing treatment cold injury as claimed in claim 2, it is characterized in that, with parts by weight, the Chinese prescription of described Chinese medicine preparation is: Ramulus Cinnamomi 22 parts, 14 parts, Fructus Jujubae, Cortex Cinnamomi 24 parts, the Radix Astragali 25 parts, Radix Angelicae Sinensis 18 parts, 17 parts, Rhizoma Zingiberis Recens, Radix Saposhnikoviae 14 parts, 15 parts, Fructus Piperis, the Radix Angelicae Dahuricae 15 parts, 12 parts, Fructus Foeniculi, Rhizoma Et Radix Notopterygii 11 parts, Radix Paeoniae Rubra 13 parts, Radix Angelicae Pubescentis 13 parts, Camphora 8 parts, 11 parts, Flos Carthami, Olibanum 6 parts, Herba Schizonepetae 16 parts, 20 parts, Radix Glycyrrhizae.
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