CN105168502A - Traditional Chinese medicine plastic for treating phase-I and phase-II pressure sores and preparation method of traditional Chinese medicine plastic - Google Patents
Traditional Chinese medicine plastic for treating phase-I and phase-II pressure sores and preparation method of traditional Chinese medicine plastic Download PDFInfo
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Abstract
The invention particularly relates to traditional Chinese medicine plastic for treating phase-I and phase-II pressure sores and a preparation method of the traditional Chinese medicine plastic and belongs to the field of traditional Chinese medicine. The traditional Chinese medicine plastic is prepared from 1%-30% of traditional Chinese medicine sugarless paste, 0.5%-5% of polyvinyl alcohol 2488, 0.5%-10% of water-soluble chitosan, 3%-10% of glycerinum, 0.5%-1.5% of polysorbate-80, 0.5%-1.5% of borneol and water. The traditional Chinese medicine clear paste is prepared from roots of Chinese barberry, Chinese mahonia leaves, Root or stem of Creeping Mallotus, radix zanthoxyli, cottonrose hibiscus leaves and radix angelicae. The plastic has the effects of promoting blood circulation to remove blood stasis, clearing away heat and toxic materials, relieving swelling and pain, resisting bacteria, diminishing inflammation and improving wound surface microcirculation disturbance and durable pain, skin channels can be dredged, toxin and necrotic tissue are removed, bruises are eliminated, and new flesh is generated by itself. The effect on the phase-I and phase-II pressure sores is remarkable, specificity is high, use is convenient, and high clinical popularization value is achieved.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind ofly treat Chinese medicine liniment of I, II phase pressure ulcer and preparation method thereof.
Background technology
Decubital ulcer or pressure ulcer are also in pressure ulcer, the long-term pressurized of tissue due to local, disturbance of blood circulation, tissue continues to be in ischemia, anoxia, underfed state, skin is made to lose normal physiological function gradually, thus the tissue damage caused and necrosis.The traditional Chinese medical science claims pressure ulcer to be " bed-sore ", and theory of Chinese medical science thinks that pressure ulcer is due to serious disease implantation seat of a specified duration, the long-term pressurized of patient, and can not change one's position, QI-blood circulation is obstructed, so that qi depression to blood stasis, and venation is obstructed, and muscle, skin, muscle arteries and veins lose for a long time and form in warm born of the same parents' scholar is foster.
Current clinical generally accepted pressure ulcer be by stages 2007 NPUAP (pressure ulcer committee of the U.S.) allotment method: suspicious deep tissue damage: because pressure or shearing cause sub-dermal soft tissue to damage the change (as purpling, reddening) of the local skin color caused, but skin complete; The I phase: skin complete, rubescent, with surrounding skin boundary clear, not fading of pressure, is often confined to the convex place of bone; The II phase: part skin blemish, the shallow stain infections of skin table, substrate is red, without incrustation, also can be bleeding blister that is complete or ulceration; The III phase: full thickness skin lacks, but muscle, tendon and skeleton not yet expose, and can have incrustation, hypodermic tunnel; The IV phase: the exposure that full thickness skin disappearance is slitted with muscle, tendon and bone, often there are incrustation and hypodermic tunnel; Can not by stages: full thickness skin lacks, and ulcer basilar part is covered with crust.
At present, the primary treatments of decubital ulcer has operation, antibiotic therapy and treatment by Chinese herbs.Operative treatment exist have a big risk and opening is large, patient suffering greatly, costly, healing is slow; Use antibiotic therapy only effective to traumatic infection, but affect wound healing time, extend patient's slight illness.And the Chinese medicine of existing treatment decubital ulcer mostly is powder or ointment etc. and falls behind dosage form, and extensively there is compatibility of drugs complexity, preparation technology is extensive, and selecting of substrate is unreasonable, causes that effective ingredient is low, consumption is excessive and drug effect such as can not to play completely at the shortcoming.
Along with development and the progress of modern medicine, medical personnel it is also proposed many new theories and method in constantly exploring and attempting.Along with the exploitation of increasing Wound dressing, these dressing have traditional dressing (as medical absorbent cotton gauze, its liquid absorption is large not, need thick wrapping and often change, and it is easily dry after imbibition, and stick together with wound and cause secondary insult), incomparable advantage: as: prevent moisture and the excessive of body fluid to scatter and disappear; Resist the invasion of antibacterial, prevent superinfection; Fit well with wound surface, but should not bond with wound surface and carry out secondary damage with free of replacement dressing belt; Moisture-inhibiting, breathe freely and make wound surface be in moistening but there is no the environment of hydrops; Good biocompatibility, has and promotes wound healing effect.
Liniment is a kind of by medicine dissolution or in being scattered in containing filmogen solvent, is coated with film forming liquid preparation for external application after putting affected part on the skin.It is simpler that it has preparation process thereof, without the need to back lining materials, do not need special machine equipment, use more convenient, and be not subject to the restriction of skin wound shape and size, do not affect normal limb activity, water resistance is better, and therefore, liniment causes the world of medicine to pay attention to day by day.
Summary of the invention
Inventor with the dialectical theory of Traditional Chinese Medicine for instruct,, new pattern compress theoretical in conjunction with modern wet union, technological innovation is again carried out to secret prescription handed down in the family from generation to generation, constantly accept the inspection put into practice simultaneously, and it is perfect gradually, provide a Be very effective, cheap, easy to use, the Chinese medicine liniment for the treatment of I, II phase pressure ulcer that specificity is higher.
For achieving the above object, the present invention adopts following technical scheme:
A kind of Chinese medicine liniment for the treatment of I, II phase pressure ulcer, it is prepared from primarily of following raw material, by weight percentage, Chinese medicine clear paste 1%-30%, polyvinyl alcohol 24880.5%-5%, water-soluble chitosan 0.5%-10%, glycerol 3%-10%, tween 80 0.5-1.5%, Borneolum Syntheticum 0.5%-1.5%, surplus are water;
Described Chinese medicine clear paste is processed by following crude drug and is prepared from: Radix Berberidis, Folium Mahoniae, Radix Seu Caulis Malloti Repandi, Radix Zanthoxyli, Folium Hibisci Mutabilis, the Radix Angelicae Dahuricae.
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Radix Zanthoxyli, Folium Hibisci Mutabilis Six-element Chinese crude drug are carried out compatibility, Effect of Chinese Medicine Qing ointment preparation conveniently obtains Chinese medicine clear paste, make Chinese medicine liniment according to Chinese medicine liniment prescription described above and act on I, II phase pressure ulcer lesion, the effect of wound surface microcirculation disturbance and persistent pain can be improved, the dredging of skin passages through which vital energy circulates can be made, malicious putrefaction removing moves back, congestive edema disperses, newly meat is spontaneous.
In order to increase the chemiluminescence of effective active composition in clear paste described above, to reach better therapeutic effect, preferably, clear paste described above is processed by the crude drug of following weight parts and is prepared from: Radix Berberidis 20-25 part, Folium Mahoniae 11-16 part, Radix Seu Caulis Malloti Repandi 13-18 part, Radix Zanthoxyli 6-11 part, Folium Hibisci Mutabilis 15-20 part, Radix Angelicae Dahuricae 7-11 part.
Further preferably, clear paste described above is processed by the crude drug of following weight parts and is prepared from: Radix Berberidis 20 parts, Folium Mahoniae 12 parts, Radix Seu Caulis Malloti Repandi 15 parts, Radix Zanthoxyli 8 parts, Folium Hibisci Mutabilis 17 parts, the Radix Angelicae Dahuricae 9 parts.Fang Zhong: Radix Berberidis bitter in the mouth cold in nature is monarch drug, can clearing away heat-damp and promoting diuresis, eliminating fire and detoxication; Folium Mahoniae are also bitter in the mouth cold in nature, purge heat and just do not hinder, and can strengthen the effect of monarch drug; The pungent bitter in the mouth of Radix Zanthoxyli property, can promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, dispelling wind and removing obstruction in the collateral; Folium Hibisci Mutabilis, removing pathogenic heat from blood and toxic substance from the body, reducing swelling and alleviating pain; Radix Seu Caulis Malloti Repandi is pungent, warm, for promoting blood circulation to remove obstruction in the collateral, removing toxic substances and promoting subsidence of swelling, dispelling wind for relieving itching; Radix Angelicae Dahuricae understand things pain-stopping, detumescence and apocenosis.All medicine synergism, there is the effect of heat clearing and damp drying, Qinghuo Jiedu, blood circulation promoting and blood stasis dispelling, removing heat from blood detumescence, antipruritic pain relieving, blood stasis dispelling granulation promoting, improve the effect of wound surface microcirculation disturbance and persistent pain, the dredging of skin passages through which vital energy circulates can be made, malicious putrefaction removing moves back, congestive edema disperses, newly meat is spontaneous.
In side, the pharmacological property of each crude drug is as follows:
Radix Berberidis: [nature and flavor] are bitter; Cold in nature.[return through] liver; Stomach; Large intestine channel.[function cures mainly] heat clearing away; Dampness; Eliminating fire and detoxication.Main dysentery due to damp-heat profit; Diarrhoea; Jaundice; Eczema; Skin infection; Aphtha; Conjunctival congestion; Pharyngalgia.
Folium Mahoniae: [nature and flavor] are bitter; Cold.[return through] liver; Stomach; Lung; Large intestine channel.[function cures mainly] heat clearing away tonify deficiency; Dampness; Removing toxic substances.Main pulmonary tuberculosis hemoptysis; Osteopyrexia and fever; Dizziness and tinnitus; Waist soreness; Jaundice due to damp-heat; Leukorrhagia; Dysentery; Anemopyretic cold; Conjunctival congestion and swelling pain; Carbuncle skin infection.[usage and dosage] takes orally: decoct soup, 6-9g.External: appropriate, grinds into powder and dresses.
Borneolum Syntheticum: [nature and flavor] are pungent, bitter, are slightly cold.[return through] GUIXIN, spleen, lung meridian.[function cures mainly] has one's ideas straightened out refreshment, clearing away heat to alleviate pain.Faint for calentura coma, convulsion, apoplexy syncope due to accumulation of phlegm, stagnation of QI sudden syncope, attacked by pestiferous factors is gone into a coma, and conjunctival congestion, aphtha, laryngopharynx swelling and pain, auditory meatus is suppurated.[usage and dosage] 0.15 ~ 0.3g, enters the loose use of ball; External levigation point applies affected part.
Radix Seu Caulis Malloti Repandi: [nature and flavor] bitter in the mouth; Pungent; Warm in nature.[return through] heart; Liver; Spleen channel.[function cures mainly] expelling wind and removing dampness; Promoting blood circulation to remove obstruction in the collateral; Removing toxic substances and promoting subsidence of swelling; Expelling insect and relieving itching.Main air arthralgia chiefly caused by damp pathogen is demonstrate,proved; Lumbago and skelalgia; Facial hemiparalysis; Traumatic injury; Carbuncle skin infection; Taeniasis; Eczema; Stubborn dermatitis; Serpentis lyssodexis.[usage and dosage] takes orally: decoct soup, 9-30g.External: appropriate, cured leaf is ground into powder, dresses; Or fresh leaf is smash deposited.
Radix Zanthoxyli: [nature and flavor] are bitter, pungent, flat; Slightly poisonous.[return through] returns liver, stomach warp.[function cures mainly] promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, dispelling wind and removing obstruction in the collateral.The traumatic injury caused for qi depression to blood stasis, rheumatic arthralgia, stomachache, toothache, venom; The burning hot wound of external treatment soup.[usage and dosage] 5 ~ 10g.Suitable amount used externally, grinds into powder and dresses or decoct washing affected part.
Folium Hibisci Mutabilis: [nature and flavor] are pungent is flat.[function cures mainly] removing heat from blood, removing toxic substances, detumescence, pain relieving.Control Yong Ju burning swelling, be burdened with herpes zoster, scalds, conjunctival congestion and swelling pain, traumatic injury.
The Radix Angelicae Dahuricae: [nature and flavor] are pungent, temperature.[return through] returns stomach, large intestine, lung meridian.[function cures mainly] loose wind dehumidifying, understand things pain-stopping, detumescence and apocenosis.For headache due to common cold, supraorbital bone pain, nasal obstruction, nasal sinusitis, toothache, leucorrhea, skin infection swells and ache.
Although conventional method is obtained that Chinese medicine clear paste can realize object of the present invention, but because Chinese medicine extract composition is comparatively complicated, may have an effect with substrate, or because of Chinese medicine extraction liquid be that height oozes system, to one-tenth membrane structure produce irreversible destruction, inventor is by optimized fabrication method, when remaining valid medicine, impurity or the part without drug effect can be removed, reducing the interference of impurity, the preparation method of clear paste described above provided by the invention, comprises the following steps:
Get Radix Zanthoxyli medical material, use water percolation, collect percolate, by percolate by macroporous adsorbent resin, first wash with water, removing is dissolved in the impurity of polar solvent, is discarded by this water elution liquid; Use the high concentration ethanol eluting of 80% again, collect to obtain Radix Zanthoxyli ethanol elution;
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Folium Hibisci Mutabilis are pulverized, decoct with water secondary, first time add water into medical material weight portion 6-8 doubly, decoct 0.5-1.0 hour, second time add water into medical material weight portion 4-6 doubly, decoct 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.05-1.10 (60 DEG C record), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get after supernatant mixes with Radix Zanthoxyli ethanol elution and reclaim ethanol, and to be concentrated into relative density be 1.15 ~ 1.20 (60 DEG C record), obtain Chinese medicine clear paste.
The obtained Chinese medicine clear paste effective active composition of said method is high, and safely, have no side effect.
The each raw material of liniment of the present invention mixes, a metastable suspension can be formed, be applied in these materials after wound surface by the volatilization of moisture and absorption, film is formed gradually around skin, be conducive to keeping wound surface moistening, its gas inaccessible, makes the property of medicine from its space between skin and muscles of pore people simultaneously, to improve the effect of wound surface microcirculation disturbance and persistent pain, the dredging of skin passages through which vital energy circulates can be made, malicious putrefaction removing moves back, congestive edema disperses, newly meat is spontaneous.
The present invention selects Borneolum Syntheticum to do transdermal enhancer, and not only transdermal effect is good, also and Borneolum Syntheticum has effect of refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.
The film-forming components be made up of polyvinyl alcohol 2488 and water-soluble chitosan, the weight ratio in film-forming agents is 1.0-15% is applicable film forming, if the concentration of film-forming components is low, not easily film forming, if concentration is too high, viscosity is large.Preferred ratio is the 3-10% that polyvinyl alcohol 2488 and water-soluble chitosan percentage by weight are in the formulation; The part by weight of polyvinyl alcohol 2488 and water-soluble chitosan is when 1:1.3-1.9, and obtained liniment filming performance is good, and fits well with wound surface, is easy to throw off; Moisture-inhibiting, breathe freely and make wound surface be in moistening but there is no the environment of hydrops; Good biocompatibility.
Present invention also offers a kind of preparation method for the treatment of the Chinese medicine liniment of I, II phase pressure ulcer, comprise the following steps:
Suitable quantity of water is heated to 50-60 DEG C, polyvinyl alcohol 2488 is added, after stirring and dissolving, add water-soluble chitosan and the abundant swelling dissolving of tween 80, make the solution containing polyvinyl alcohol and water-soluble chitosan, add glycerol and stir, then above-mentioned gained Chinese medicine clear paste and Borneolum Syntheticum is added, be uniformly mixed, moisturizing is uniformly mixed to recipe quantity, to obtain final product.
The present invention is further illustrated below by way of testing.
One, the safety evaluation test of Chinese medicine liniment of the present invention
This test carries out EXPERIMENTAL DESIGN with reference to " technological guidance's principle of Chinese medicine, natural drug studies on acute toxicity ", " technological guidance's principle that Chinese medicine, natural drug stimulate and hemolytic is studied ", " technological guidance's principle that Chinese medicine, crude drug immunogenicity (irritated, photosensitivity reaction) are studied ", adopt Rabbits with Acute toxicity, rabbit skin irritation and guinea pig skin sensitivity test, toxicological evaluation is carried out to the safety of Chinese medicine liniment, and according to result of the test for the clinical research of Chinese medicine liniment provides test basis.
1. skin sensibiligen experiment
Select 20 Japan large ear rabbits to be divided into 4 groups at random, often organize 5.I.e. intact skin liniment Matrix controls group, intact skin liniment group, damaged skin liniment matrix group, damaged skin liniment group.Test front razor hair is taken off, depilation scope is 150cm (10% of about suitable rabbit body surface area), checks that whether shave hair-fields has damage, rejects skin damage rabbit after 24h, subsequently the liniment of the test medicine embodiment of the present invention 1 is evenly applied to depilation district, sub-cage rearing; Damaged skin group first will lose hair or feathers position with after 75% alcohol disinfecting, and cause local scratch with emery cloth paper in the friction of depilation position, the degree of being with oozing of blood, immediately in damaged part medication, concrete dosage and coating method are with above-mentioned intact skin group.Medicine film is thrown off after 24h, after warm water cleaning tested material, observe every day and record rabbit general manifestation and intoxication conditions, specifically comprise the change of the change, breathing, circulation, central nervous system, extremity activity etc. of the body weight of animal, depilation district red swelling of the skin degree, hair, eye and mucosa, if chance animal dead, then postmortem in time, perusal also carries out histopathologic examination.
Result: liniment of the present invention and liniment substrate all do not cause anomalous effects to the skin conditions of complete, damaged skin rabbit, feed, stool, breathing, heart beating, eye and mucosa, central nervous system, extremity activity.Before carrying out coating, after coating 3,7, the weight differences of 14d, we find in the observation period, and each treated animal continued weight increases, and compares there was no significant difference (P > 0.05) between organizing.There is not any acute toxic reaction, without death condition in 4 groups of rabbit in observation period 14d.Experimental result shows, liniment of the present invention to intact skin and damaged skin skin all without obvious acute toxic reaction.
In an experiment, perusal find, liniment of the present invention to normal skin there are no any harmful effect; To damaged skin, liniment matrix group before administration rear 3d, without significant change, starts incrustation after 4d, and namely liniment of the present invention 1d after coating starts incrustation, and after 3d, incrustation starts to come off.Experiment shows liniment of the present invention to rabbit normal skin without any harmful effect, damaged skin is then had to the effect of wound healing.
2. single-dose skin irritation test
Get healthy Japan large ear rabbit 10, male and female are not limit, and are divided into 2 groups at random, i.e. intact skin and damaged skin liniment group of the present invention, often organize 5.Test front razor to be taken off by hair, depilation scope is 150cm (10% of about suitable rabbit body surface area).After depilation, the liniment primary coating that the tested material embodiment of the present invention 1 is prepared by intact skin group is on the skin of animal subject; Damaged skin group first will lose hair or feathers position with after 75% alcohol disinfecting, local scratch is caused in the friction of depilation position with dry sanding paper, the degree of being with oozing of blood, immediately in damaged part administration, medicine film is thrown off after 24h, use warm water cleaning medicine, observation 1,24,48 and 72h medicine-feeding part are with or without the situation such as erythema, edema.
Result: single smear the embodiment of the present invention 1 prepare liniment and substrate after rabbit intact skin have no the irritant reaction such as erythema or edema, damaged skin liniment Matrix controls group upon administration 4d incrustation; And namely liniment of the present invention 1d after coating starts incrustation, after 3d, incrustation starts to come off.
3. skin hypersensitivity experiment
Healthy adult Cavia porcellus, male and female are not limit, and are divided into 4 groups at random, namely blank group, liniment matrix group of the present invention, liniment group of the present invention and 2,4-dinitrochlorobenzene group (be configured to before use 1% sensitization concentration and 0.1% excite concentration), often organize 10.Test front razor hair to be shaved totally, after scope 3cm × 3cm, 24h, check whether depilation district has damage, rejects skin damage Cavia porcellus.
By the liniment of the embodiment of the present invention 1 and substrate (every 0.2g) and 2,4-dinitrochlorobenzene (every 0.2mL) respectively at after depilation after 24h uniform application to lose hair or feathers on the right side of the back of each group of corresponding Cavia porcellus district's skin, sub-cage rearing, removes left drug with warm water after continuing 6h.7d and 14d, in kind repeats once.
14d after last administration sensitization, by liniment, substrate and DNFB (concentration 0.1%, dosage 0.2mL) the uniform application left dorsal depilation district skin in each group of corresponding Cavia porcellus, sub-cage rearing, removes left drug with warm water after continuing 6h.At once (0h) observes dermoreaction situation, then continues to observe skin allergy situation in 24,48 and 72h.
Result: liniment group of the present invention and each 10 guinea pig skins of matrix group thereof do not occur erythema and edema, without systemic anaphylaxis phenomenons such as asthma, astasia or shocks yet.Occur erythema after the self-excitation administration of DNFB treated animal tested skin district, 6h is the most obvious, disappears gradually after 36h, and after 72h, erythema is still visible reluctantly, and sensitization rate reaches 100%.Do not occur in 72h after liniment of the present invention and the self-excitation administration of matrix group guinea pig skin tested district thereof that erythema and edema are formed, and compare indifference with blank group, illustrate that Chinese medicine liniment of the present invention and substrate thereof can not cause skin allergy.
To sum up, experimental result shows that liniment of the present invention is complete to rabbit when the single drug of topical application reaches clinical application amount 100 times, also nonirritant effect does not all appear toxic reaction, in damaged skin, also has no generation sensitization to guinea pig skin.The treatment of pointing out liniment percutaneous dosing of the present invention to be used for the diseases such as wound healing is safe.
Two, clinical observation test
1. data and method
1.1 physical data: choose in January ,-2015 in November, 2013 and be admitted to hospital in Linyi City hospital Pneumology Department, ICU, emergency department, collect record complete observation case 116 example, pressure ulcer amounts to 124 places.Wherein sacrococcygeal region 69 place, heel 28 place, scapular region 21 place, ancon 6 place.According to pressure ulcer by stages, the I phase 78 place, the II phase 46 place.Treatment group 58 example is got, matched group 58 example according to randomized blocks.Two groups of patient ages, sex, pressure ulcer position and pressure ulcers are by stages by statistical analysis, and no significant difference (P > 0.05), has comparability.
1.2 inclusion criterias: the patient being judged as I phase, II phase according to NPUAP (pressure ulcer committee of the U.S.) pressure ulcer staging scale in 2007; Patient agrees to and coordinates research approach, agrees to that performing safety detects.
1.3 exclusion standards: allergic constitution person and to liniment composition allergy sufferers of the present invention; Be associated with the patient of the serious condition such as severe complication; The underfed patient of cancer of late stage; Age is greater than 85 years old, overall health of patients difference person; In tested process, change of illness state is obvious, should not accept experimenter again; Experimenter raises an objection over the course for the treatment of, refuses this therapeutic scheme person, and the one of the above situation of all genus, is all got rid of.
1.4 Therapeutic Method:
Primary Care: to entering to organize after patient assesses, set up evaluation form and stand up card, assisting patients stands up 1 time in every 2 hours, uses 30 ° of lateral positions to change asanas replacing positions.Every day, 2 cleaning patient sheets, ensured dry, clean and tidy.
Matched group: after Primary Care, every day 2 times is with polyvidone cotton balls sterilization patient affected part.If there is large blister, uses asepsis injector to extract liquid in bubble out, then extrude remaining liq in bubble by aseptic swab stick, and then use the sterilization of polyvidone cotton balls, if wound has secretions, first clean affected part with normal saline, then carry out cotton balls sterilization.
Treatment group: after Primary Care, be coated on wound surface by liniment prepared by the embodiment of the present invention 1, every day changes dressings 1-2 time.All observe treatment 2 weeks for two groups.
1.5 observation index:
1.5.1 two kinds for the treatment of meanss are observed to the curative effect of patient pain, pain scores after evaluating that two groups of patients are front and changing dressings for 5 times, pain degree scoring criterion: 0 point: painless; 1 point: a little pain; 2 points: slightly pain; 3 points: more pain; 4 points: very pain; 5 points: the most bitterly.
The scoring event of the large Small Indicators of pressure ulcer, wound surface situation, surrounding skin situation etc. before 1.5.2 observing two groups of patient treatments and after treatment, respectively every index is carried out to the calculating of point value difference, score value due to index is higher, and to represent the state of an illness heavier, so, mark difference before and after treatment is larger, illustrates that the curative effect for the treatment of is better.Evaluate the curative effect of two kinds of methods.
Pressure ulcer size scoring criterion: 10 points: > 24cm
2; 9 points: 12.1-24cm
2; 8 points: 8.1-12.0cm
2; 7 points: 4.1-8cm
2; 6 points: 3.1-4.0cm
2; 5 points: 2.1-3.0cm
2; 4 points: 1.1-2.0cm
2; 3 points: 0.7-1.0cm
2; 2 points: 0.3-0.6cm
2; 1 point: < 0.3cm
2; 0 point: 0cm
2.
Wound surface situation scoring criterion: 5 points: shallow open ulcer appears in local, and skin is purplish red, congested, swelling, has blister; 4 points: shallow putting property of Jian ulcer appears in local, do not occur that blister or blister become flat, skin is pale red; 3 points: skin complete, wound surface is rubescent, and not going of pressure, has Mild edema, surface heat; 2 points: skin complete, but there is color change, as pale red, purple, brown etc., wound surface color alleviates than before; 1 point: normal.
Surrounding skin scoring criterion: 5 points: be partially formed table fester, surrounding skin floods, occurs erythema, edema; 4 points: be partially formed table fester, surrounding skin only occurs erythema; 3 points: surrounding skin is complete, there are scleroma, heating, redness etc.; 2 points: surrounding skin is complete, erythema comparatively before alleviates, without heating, redness etc.; 1 point: normal, without significant change.
1.6 efficacy evaluations: with reference to " disease of tcm Standardization of diagnosis and curative effect ", observe two groups of patients at pre-treatment and after treatment, the situation of change of pressure ulcer.Effective: to observe local, affected part redness and disappear, wound healing.Effective: local redness disappears, and blister disappears, and wound surface reduces or substantially disappears.Take a turn for the better: the red and swollen range shorter of illing skin, blister subsides, and transudate reduces.Invalid: after the treatment of affected part, effect changes not obvious.Wherein, treat effective, effective, transfer total effective rate to well.
1.7 statistical procedures: application SPSS16.0 statistical software.Measurement data with
represent, and adopt t inspection to data, enumeration data adopts X 2 test, and P < 0.05 has statistical significance for difference.
2. result
The comparison of 2.1 pain of patients changing dressing scoring averages: two groups of patient's front 5 pain of patients changing dressings scoring Average value compare the results are shown in Table 1.Front 5 the pain scores averages for the treatment of group patient are lower, compare with matched group, and difference has statistical significance (P < 0.05).
Table 1: two groups of patient's front 5 pain of patients changing dressings scoring Average value compare
Note: compare with matched group, * P < 0.05.
The size of 2.2 pressure ulcers compares: the comparison of pressure ulcer magnitude difference after two groups of patient treatments, the results are shown in Table 2.Treatment group is obviously better than matched group, and difference has statistical significance (P < 0.05).
The comparison of pressure ulcer magnitude difference after table 2 liang group patient treatment
Note: compare with matched group, * P < 0.05.
The comparison of 2.3 liang of group wounds and surrounding skin situation: after two groups of patient treatments, the comparative result of wound surface and surrounding skin situation difference is in table 3.Treatment group is obviously better than matched group, and difference has statistical significance (P < 0.05).
The comparison of table 3 liang group wounds and periphery situation
Note: compare with matched group, * P < 0.05.
2.4 liang of group Clinical efficacy comparisons: treatment group recovery from illness 16 example, effective 24 examples, total effective rate 90.9%; Matched group recovery from illness 11 example, effective 17 examples, total effective rate 66.7%, two groups of total effective rate comparing differences have statistical significance (P < 0.05), and treatment group curative effect is obviously better than matched group, in table 4.
Table 4: two groups of Clinical efficacy comparisons after two courses for the treatment of: example (%)
Note: compare with matched group, * P < 0.05.
This clinical test results shows: on situation three Indexes Comparison of pressure ulcer size, wound surface situation, surrounding skin, treatment group is all better than matched group, and difference has statistical significance, overall merit, and treatment group total effective rate is significantly better than matched group.
In a word, the present invention has following beneficial effect:
Prescription of the present invention is rigorous, compatibility relationship is clear and definite, all medicine 5 use, has blood circulation promoting and blood stasis dispelling, the effect of heat-clearing and toxic substances removing, reducing swelling and alleviating pain, anti-inflammation, improve the effect of wound surface microcirculation disturbance and persistent pain, the dredging of skin passages through which vital energy circulates can be made, malicious putrefaction removing moves back, congestive edema disperses, newly meat is spontaneous; Antibacterial is made to lose the environment of existence by the change of Physiology and biochemistry environment, thus the inflammation that minimizing health causes bacteriotoxic immunoreation; Liniment adheres to affected part, can completely cut off antibacterial and be conducive to wound surface by self-dissolving to clean, by the absorption of skin soft tissue, and through sick institute, and the relative potence of drug level is produced in local, foreign body is removed in evacuation of pus of drawing out the pus; Liniment has adsorption to the tissue fluid produced, and adhesion skin again, is easy to tear off, and can not cause secondary injury, and good air permeability, easy to use, there is larger clinical generalization value.
Detailed description of the invention
Further describe the present invention below by way of detailed description of the invention, but the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the present invention is suitably improved, replaces the identical component of effect, will become apparent to those skilled in the art that they are all deemed to be included within scope of the present invention.
Embodiment 1
Clear paste prescription: Radix Berberidis 20 parts, Folium Mahoniae 12 parts, Radix Seu Caulis Malloti Repandi 15 parts, Radix Zanthoxyli 8 parts, Folium Hibisci Mutabilis 17 parts, the Radix Angelicae Dahuricae 9 parts;
Liniment prescription (by weight percentage): Chinese medicine clear paste 12%, polyvinyl alcohol 24881.3%, water-soluble chitosan 1.9%, glycerol 6%, tween 80 0.8%, Borneolum Syntheticum 1.0%, water 77.0%;
Liniment preparation method: get Radix Zanthoxyli medical material, uses water percolation, collects percolate, by percolate by macroporous adsorbent resin, first washes with water, and removing is dissolved in the impurity of polar solvent, is discarded by this water elution liquid; Use the high concentration ethanol eluting of 80% again, collect to obtain Radix Zanthoxyli ethanol elution;
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Folium Hibisci Mutabilis are pulverized, decoct with water secondary, first time add water into medical material weight portion 6-8 doubly, decoct 0.5-1.0 hour, second time add water into medical material weight portion 4-6 doubly, decoct 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.08 (60 DEG C record), adding ethanol makes the volumn concentration of ethanol reach 65%, and after stirring, precipitate with ethanol leaves standstill; Get after supernatant mixes with Radix Zanthoxyli ethanol elution and reclaim ethanol, and to be concentrated into relative density be 1.17 (60 DEG C record), obtain Chinese medicine clear paste;
Suitable quantity of water is heated to 55 DEG C, polyvinyl alcohol 2488 is added, after stirring and dissolving, add water-soluble chitosan and the abundant swelling dissolving of tween 80, make the solution containing polyvinyl alcohol and water-soluble chitosan, add glycerol and stir, then above-mentioned gained Chinese medicine clear paste and Borneolum Syntheticum is added, be uniformly mixed, moisturizing is uniformly mixed to recipe quantity, to obtain final product.
Embodiment 2
Clear paste prescription: Radix Berberidis 20 parts, Folium Mahoniae 12 parts, Radix Seu Caulis Malloti Repandi 15 parts, Radix Zanthoxyli 8 parts, Folium Hibisci Mutabilis 17 parts, the Radix Angelicae Dahuricae 9 parts;
Liniment prescription (by weight percentage): Chinese medicine clear paste 15%, polyvinyl alcohol 24881.7%, water-soluble chitosan 2.6%, glycerol 8%, tween 80 1.0%, Borneolum Syntheticum 1.0%, water 70.7%;
Liniment preparation method: get Radix Zanthoxyli medical material, uses water percolation, collects percolate, by percolate by macroporous adsorbent resin, first washes with water, and removing is dissolved in the impurity of polar solvent, is discarded by this water elution liquid; Use the high concentration ethanol eluting of 80% again, collect to obtain Radix Zanthoxyli ethanol elution;
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Folium Hibisci Mutabilis are pulverized, decoct with water secondary, first time add water into medical material weight portion 6-8 doubly, decoct 0.5-1.0 hour, second time add water into medical material weight portion 4-6 doubly, decoct 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.05 (60 DEG C record), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get after supernatant mixes with Radix Zanthoxyli ethanol elution and reclaim ethanol, and to be concentrated into relative density be 1.15 (60 DEG C record), obtain Chinese medicine clear paste;
Suitable quantity of water is heated to 53 DEG C, polyvinyl alcohol 2488 is added, after stirring and dissolving, add water-soluble chitosan and the abundant swelling dissolving of tween 80, make the solution containing polyvinyl alcohol and water-soluble chitosan, add glycerol and stir, then above-mentioned gained Chinese medicine clear paste and Borneolum Syntheticum is added, be uniformly mixed, moisturizing is uniformly mixed to recipe quantity, to obtain final product.
Embodiment 3
Clear paste prescription: Radix Berberidis 25 parts, Folium Mahoniae 15 parts, Radix Seu Caulis Malloti Repandi 16 parts, Radix Zanthoxyli 10 parts, Folium Hibisci Mutabilis 15 parts, the Radix Angelicae Dahuricae 10 parts;
Liniment prescription (by weight percentage): Chinese medicine clear paste 10%, polyvinyl alcohol 24881.5%, water-soluble chitosan 2.7%, glycerol 7.3%, tween 80 0.9%, Borneolum Syntheticum 1.1%, water 76.5%;
Liniment preparation method: get Radix Zanthoxyli medical material, uses water percolation, collects percolate, by percolate by macroporous adsorbent resin, first washes with water, and removing is dissolved in the impurity of polar solvent, is discarded by this water elution liquid; Use the high concentration ethanol eluting of 80% again, collect to obtain Radix Zanthoxyli ethanol elution;
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Folium Hibisci Mutabilis are pulverized, decoct with water secondary, first time add water into medical material weight portion 6-8 doubly, decoct 0.5-1.0 hour, second time add water into medical material weight portion 4-6 doubly, decoct 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.10 (60 DEG C record), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get after supernatant mixes with Radix Zanthoxyli ethanol elution and reclaim ethanol, and to be concentrated into relative density be 1.20 (60 DEG C record), obtain Chinese medicine clear paste;
Suitable quantity of water is heated to 57 DEG C, polyvinyl alcohol 2488 is added, after stirring and dissolving, add water-soluble chitosan and the abundant swelling dissolving of tween 80, make the solution containing polyvinyl alcohol and water-soluble chitosan, add glycerol and stir, then above-mentioned gained Chinese medicine clear paste and Borneolum Syntheticum is added, be uniformly mixed, moisturizing is uniformly mixed to recipe quantity, to obtain final product.
Embodiment 4
Clear paste prescription: Radix Berberidis 23 parts, Folium Mahoniae 15 parts, Radix Seu Caulis Malloti Repandi 13 parts, Radix Zanthoxyli 10 parts, Folium Hibisci Mutabilis 15 parts, the Radix Angelicae Dahuricae 11 parts;
Liniment prescription (by weight percentage): Chinese medicine clear paste 20%, polyvinyl alcohol 24882.5%, water-soluble chitosan 3.5%, glycerol 6%, tween 80 1.0%, Borneolum Syntheticum 1.0%, water 66%;
Liniment preparation method: get Radix Zanthoxyli medical material, uses water percolation, collects percolate, by percolate by macroporous adsorbent resin, first washes with water, and removing is dissolved in the impurity of polar solvent, is discarded by this water elution liquid; Use the high concentration ethanol eluting of 80% again, collect to obtain Radix Zanthoxyli ethanol elution;
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Folium Hibisci Mutabilis are pulverized, decoct with water secondary, first time add water into medical material weight portion 6-8 doubly, decoct 0.5-1.0 hour, second time add water into medical material weight portion 4-6 doubly, decoct 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.07 (60 DEG C record), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get after supernatant mixes with Radix Zanthoxyli ethanol elution and reclaim ethanol, and to be concentrated into relative density be 1.15 (60 DEG C record), obtain Chinese medicine clear paste;
Suitable quantity of water is heated to 55 DEG C, polyvinyl alcohol 2488 is added, after stirring and dissolving, add water-soluble chitosan and the abundant swelling dissolving of tween 80, make the solution containing polyvinyl alcohol and water-soluble chitosan, add glycerol and stir, then above-mentioned gained Chinese medicine clear paste and Borneolum Syntheticum is added, be uniformly mixed, moisturizing is uniformly mixed to recipe quantity, to obtain final product.
Embodiment 5
Clear paste prescription: Radix Berberidis 25 parts, Folium Mahoniae 12 parts, Radix Seu Caulis Malloti Repandi 18 parts, Radix Zanthoxyli 8 parts, Folium Hibisci Mutabilis 17 parts, the Radix Angelicae Dahuricae 10 parts;
Liniment prescription (by weight percentage): Chinese medicine clear paste 13%, polyvinyl alcohol 24881.5%, water-soluble chitosan 2.3%, glycerol 6.7%, tween 80 0.9%, Borneolum Syntheticum 1.1%, water 74.5%;
Liniment preparation method: the operation with reference to embodiment 1-4 is carried out.
Embodiment 6
Clear paste prescription: Radix Berberidis 20 parts, Folium Mahoniae 12 parts, Radix Seu Caulis Malloti Repandi 15 parts, Radix Zanthoxyli 8 parts, Folium Hibisci Mutabilis 17 parts, the Radix Angelicae Dahuricae 9 parts;
Liniment prescription (by weight percentage): Chinese medicine clear paste 17%, polyvinyl alcohol 24881.6%, water-soluble chitosan 2.4%, glycerol 7%, tween 80 0.5%, Borneolum Syntheticum 0.5%, water 71%;
Liniment preparation method: the operation with reference to embodiment 1-4 is carried out.
Embodiment 7
Clear paste prescription: Radix Berberidis 25 parts, Folium Mahoniae 15 parts, Radix Seu Caulis Malloti Repandi 15 parts, Radix Zanthoxyli 10 parts, Folium Hibisci Mutabilis 20 parts, the Radix Angelicae Dahuricae 10 parts;
Liniment prescription (by weight percentage): Chinese medicine clear paste 11%, polyvinyl alcohol 24881.8%, water-soluble chitosan 3.5%, glycerol 7.5%, tween 80 0.8%, Borneolum Syntheticum 1.0%, water 74.4%;
Liniment preparation method: the operation with reference to embodiment 1-4 is carried out.
Claims (7)
1. treat the Chinese medicine liniment of I, II phase pressure ulcer for one kind, it is characterized in that being prepared from primarily of following raw material, by weight percentage, Chinese medicine clear paste 1%-30%, polyvinyl alcohol 24880.5%-5%, water-soluble chitosan 0.5%-10%, glycerol 3%-10%, tween 80 0.5-1.5%, Borneolum Syntheticum 0.5%-1.5%, surplus are water;
Described Chinese medicine clear paste is processed by following crude drug and is prepared from: Radix Berberidis, Folium Mahoniae, Radix Seu Caulis Malloti Repandi, Radix Zanthoxyli, Folium Hibisci Mutabilis, the Radix Angelicae Dahuricae.
2. Chinese medicine liniment as claimed in claim 1, is characterized in that described Chinese medicine clear paste is processed by the crude drug of following weight portion and is prepared from: Radix Berberidis 20-25 part, Folium Mahoniae 11-16 part, Radix Seu Caulis Malloti Repandi 13-18 part, Radix Zanthoxyli 6-11 part, Folium Hibisci Mutabilis 15-20 part, Radix Angelicae Dahuricae 7-11 part.
3. Chinese medicine liniment as claimed in claim 2, is characterized in that described Chinese medicine clear paste is processed by the crude drug of following weight portion and is prepared from: Radix Berberidis 20 parts, Folium Mahoniae 12 parts, Radix Seu Caulis Malloti Repandi 15 parts, Radix Zanthoxyli 8 parts, Folium Hibisci Mutabilis 17 parts, the Radix Angelicae Dahuricae 9 parts.
4. the Chinese medicine liniment as described in claim 1-3, is characterized in that the preparation method of described Chinese medicine clear paste, comprises the following steps:
Get Radix Zanthoxyli medical material, use water percolation, collect percolate, by percolate by macroporous adsorbent resin, first wash with water, removing is dissolved in the impurity of polar solvent, is discarded by this water elution liquid; Use the high concentration ethanol eluting of 80% again, collect to obtain Radix Zanthoxyli ethanol elution;
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Folium Hibisci Mutabilis are pulverized, decoct with water secondary, first time add water into medical material weight portion 6-8 doubly, decoct 0.5-1.0 hour, second time add water into medical material weight portion 4-6 doubly, decoct 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.05-1.10 (60 DEG C record), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get after supernatant mixes with Radix Zanthoxyli ethanol elution and reclaim ethanol, and to be concentrated into relative density be 1.15 ~ 1.20 (60 DEG C record), obtain Chinese medicine clear paste.
5. the Chinese medicine liniment as described in claim 1-4, is characterized in that the 3-10% that the percentage by weight of described polyvinyl alcohol 2488 and water-soluble chitosan is preferably.
6. Chinese medicine liniment as claimed in claim 5, is characterized in that described polyvinyl alcohol 2488 is 1:1.3-1.9 with the weight ratio ratio of water-soluble chitosan.
7. the Chinese medicine liniment as described in claim 1-6, it is characterized in that its preparation method comprises the following steps: get Radix Zanthoxyli medical material, use water percolation, collect percolate, percolate is passed through macroporous adsorbent resin, first wash with water, removing is dissolved in the impurity of polar solvent, is discarded by this water elution liquid; Use the high concentration ethanol eluting of 80% again, collect to obtain Radix Zanthoxyli ethanol elution;
Radix Berberidis, Folium Mahoniae, the Radix Angelicae Dahuricae, Radix Seu Caulis Malloti Repandi, Folium Hibisci Mutabilis are pulverized, decoct with water secondary, first time add water into medical material weight portion 6-8 doubly, decoct 0.5-1.0 hour, second time add water into medical material weight portion 4-6 doubly, decoct 1.5-2.0 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.05-1.10 (60 DEG C record), adding ethanol makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get after supernatant mixes with Radix Zanthoxyli ethanol elution and reclaim ethanol, and to be concentrated into relative density be 1.15 ~ 1.20 (60 DEG C record), obtain Chinese medicine clear paste.
Suitable quantity of water is heated to 50-60 DEG C, polyvinyl alcohol 2488 is added, after stirring and dissolving, add water-soluble chitosan and the abundant swelling dissolving of tween 80, make the solution containing polyvinyl alcohol and water-soluble chitosan, add glycerol and stir, then above-mentioned gained Chinese medicine clear paste and Borneolum Syntheticum is added, be uniformly mixed, moisturizing is uniformly mixed to recipe quantity, to obtain final product.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20100079858A (en) * | 2008-12-31 | 2010-07-08 | 지에스씨 영농조합법인 | The new medicine for skin disease composed of mineral and medical herbs |
| CN104189063A (en) * | 2014-08-12 | 2014-12-10 | 刘学勤 | Externally-applied medicinal wine for treating pressure sore |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20100079858A (en) * | 2008-12-31 | 2010-07-08 | 지에스씨 영농조합법인 | The new medicine for skin disease composed of mineral and medical herbs |
| CN104189063A (en) * | 2014-08-12 | 2014-12-10 | 刘学勤 | Externally-applied medicinal wine for treating pressure sore |
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| 关靖: "陈宝元教授治疗疮疡疾病的学术思想初探", 《四川中医》 * |
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