Summary of the invention
Inventor is on the basis of older generation doctor tcm characteristic treatment decubital ulcer, constantly accept the inspection put into practice, and improve summary gradually, provide the Chinese medicine liniment a kind of clinical care being used for the treatment of two, three phase decubital ulcers, this liniment not only has the effect of heat-clearing and toxic substances removing, reducing swelling and alleviating pain, removing the necrotic tissue and promoting granulation, and plasticity is good after film forming, resistance to tension is strong, and elasticity is fine, has adsorption to the tissue fluid produced, not tearing skin, without dry tight sense.
In order to realize object of the present invention, the invention provides the Chinese medicine liniment a kind of clinical care being used for the treatment of two, three phase decubital ulcers, it is made up of following Chinese crude drug: Radix seu Caulis Schisandrae Sinensis, red Herba violae patrinii, herb Potentillae cryptotaeniae, Herba Lycopodii serrati, Herba Rabdosiae Lophanthoidis, Radix Arnebiae (Radix Lithospermi), Rhizoma Polygoni Cuspidati, Folium Ilicis Purpureae.
Preferably, clinical care of the present invention is used for the treatment of the Chinese medicine composition of decubital ulcer, it is made up of the Chinese crude drug of following weight proportioning: Radix seu Caulis Schisandrae Sinensis 10-25 part, red Herba violae patrinii 20-40 part, herb Potentillae cryptotaeniae 10-20 part, Herba Lycopodii serrati 5-15 part, Herba Rabdosiae Lophanthoidis 20-50 part, Radix Arnebiae (Radix Lithospermi) 8-18 part, Rhizoma Polygoni Cuspidati 6-26 part, Folium Ilicis Purpureae 15-30 part.
Preferably, clinical care of the present invention is used for the treatment of the Chinese medicine composition of decubital ulcer, it is made up of the Chinese crude drug of following weight proportioning: Radix seu Caulis Schisandrae Sinensis 15-20 part, red Herba violae patrinii 26-30 part, herb Potentillae cryptotaeniae 12-16 part, Herba Lycopodii serrati 8-13 part, Herba Rabdosiae Lophanthoidis 35-40 part, Radix Arnebiae (Radix Lithospermi) 10-15 part, Rhizoma Polygoni Cuspidati 11-16 part, Folium Ilicis Purpureae 23-28 part.
Preferably, clinical care of the present invention is used for the treatment of the Chinese medicine composition of decubital ulcer, it is made up of the Chinese crude drug of following weight proportioning: Radix seu Caulis Schisandrae Sinensis 16 parts, red Herba violae patrinii 30 parts, herb Potentillae cryptotaeniae 15 parts, Herba Lycopodii serrati 10 parts, Herba Rabdosiae Lophanthoidis 35 parts, Radix Arnebiae (Radix Lithospermi) 12 parts, Rhizoma Polygoni Cuspidati 12 parts, Folium Ilicis Purpureae 25 parts.
Fang Xiewei of the present invention: Radix seu Caulis Schisandrae Sinensis removing toxic substances and promoting subsidence of swelling in side, regulating QI to relieve pain, promoting blood circulation to remove blood stasis; Red Herba violae patrinii heat-clearing and toxic substances removing, reducing swelling and alleviating pain; Two medicine compatibilities use, and heat-clearing and toxic substances removing, reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling is monarch drug.Folium Ilicis Purpureae heat-clearing and toxic substances removing, Herba Rabdosiae Lophanthoidis heat-clearing and toxic substances removing, inducing diuresis and reducing edema; Radix Arnebiae (Radix Lithospermi) promoting blood circulation and cooling blood, removing toxic substances rash; Three medicine compatibilities use, clearing away heat and cooling blood, and removing toxic substances and promoting subsidence of swelling power is strong, is ministerial drug.Herb Potentillae cryptotaeniae heat-clearing and toxic substances removing, sore is stopped blooding, eliminating stasis to stop pain; Herba Lycopodii serrati heat-clearing and toxic substances removing, eliminating dampness and astringing sores, analgesic therapy dissipating blood stasis; Rhizoma Polygoni Cuspidati expelling wind and removing dampness, dissipating blood stasis analgesic therapy, assistant monarch-minister drug heat-clearing and toxic substances removing, reducing swelling and alleviating pain, makes wound healing.The all medicines of we are combined into it, there is the effect of heat-clearing and toxic substances removing, anti-inflammation, reducing swelling and alleviating pain, removing the necrotic tissue and promoting granulation, expansible blood vessel, promote local blood circulation, improve surrounding tissue nutrition, the rotten tissue of a large amount of necrosis is come off rapidly eliminating, and newly granulate the ramp along with microcirculatory improvement.
Each Chinese crude drug all with the medicinal part recorded in the ancient books and records such as " Chinese Pharmacopoeia " " China book on Chinese herbal medicine " for standard, pharmacological activity present Research is as described below.
Radix seu Caulis Schisandrae Sinensis: [source] medical material Ji Yuan: be ratan or the root of Schisandraceae Plant Cortex cynoglossi zeylanici radicis.[nature and flavor] are pungent; Warm in nature.[function cures mainly] expelling wind and activating blood circulation; Removing toxic substances and promoting subsidence of swelling; Hemostasis.Main rheumatic numbness; Bones and muscles pain; Traumatic injury; Menoxenia; Stomachache; Abdominal distention; Carbuncle sore tumefacting virus; Over-strained hemoptysis.
Red Herba violae patrinii: [source] medical material Ji Yuan: be the herb of Violaceae plant drumsticks common violet.[nature and flavor] are lightly seasoned; Cold in nature.[function cures mainly] heat-clearing and toxic substances removing; Reducing swelling and alleviating pain.Main cough due to lung-heat; Acute infectious hepatitis; Furuncle toxic swelling; Traumatic injury.
Herb Potentillae cryptotaeniae: [source] medical material Ji Yuan: be root and the herb of rosaceous plant Herba Potentillae Freynianae and Chinese Herba Potentillae Freynianae.[nature and flavor] are sweet; Temperature.[return through] lung; Large intestine; Stomach; Liver Channel.[function cures mainly] heat-clearing and toxic substances removing, sore is stopped blooding, eliminating stasis to stop pain.Main cough, dysentery, enteritis, carbuncle furuncle, scalds, aphtha of the mouth and tongue, osteomyelitis, bone tuberculosis, scrofula, hemorrhoid, venom, metrorrhagia, menorrhagia, postpartum hemorrhage, traumatic hemorrhage, stomachache, toothache, sternalgia, lumbago, traumatic injury.
Herba Lycopodii serrati: [source] medical material Ji Yuan: be the herb of Huperziaceae plant Herba Lycopodii serrati.[nature and flavor] are pungent; Sweet; Micro-hardship; Flat; Temperature; Cool; Acid; Mild toxicity.[return through] lung; Large intestine; Liver; Kidney channel.[function cures mainly] heat-clearing and toxic substances removing; Eliminating dampness and astringing sores; Hemostasis analgesic therapy dissipating blood stasis; Detumescence.Main pneumonia; Lung abscess; Over-strained hemoptysis; Hemorrhoidal hemorrhage; Leucorrhea; Traumatic injury; Toxic swelling; Water hygral expansion; Ulcer does not close up for a long time; Burn and scald.
Herba Rabdosiae Lophanthoidis: [source] medical material Ji Yuan: be the herb of labiate brookweed and Rabdosia lophanthoides.[nature and flavor] bitter in the mouth; Cold in nature.[return through] returns liver; Gallbladder; Large intestine channel.[function cures mainly] heat-clearing and toxic substances removing; Dampness removing jaundice eliminating; Dissipating blood stasis for subsidence of swelling.Main damp and hot yellow cellulitis; Cholecystitis; Have loose bowels; Skin ulcer swells; Traumatic pain.
Radix Arnebiae (Radix Lithospermi): [source] this product is the dry root of comfrey lithospermum euchromum Royle Arnebiaeuchroma (Royle) Johnst., Radix Arnebiae (Radix Lithospermi) LithospermumerythrorhizonSieb.etZucc. or arnebia guttata Bunge ArnebiaguttataBunge.Spring, Qiu Erji excavate, removing silt, dry.[nature and flavor] are sweet, salty, cold.[return through] GUIXIN, Liver Channel.[function cures mainly] removing heat from blood, invigorates blood circulation, removing toxic substances rash.Contain for heat in blood poison, macule purple is black, measles without adequate eruption, skin infection, eczema, burn due to hot liquid or fire.
Rhizoma Polygoni Cuspidati: [process of preparing Chinese medicine] removing impurity, cleans, runs through, cut sheet, dry.[nature and flavor] micro-hardship, is slightly cold.[return through] returns liver, gallbladder, lung meridian.[function cures mainly] expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.For arthralgia, jaundice due to damp-heat, amenorrhea, lump in the abdomen, burn due to hot liquid or fire, injury from falling down, carbuncle sore tumefacting virus, cough with copious phlegm.
Folium Ilicis Purpureae: [nature and flavor] are pained, cold.[function cures mainly] controls scald, ulcer disunion of a specified duration, thromboangiitis obliterans, acute and chronic bronchitis, pneumonia, urinary tract infection, and bacillary dysentery, traumatic hemorrhage, freezes chilblain, chaps.
Present invention also offers a kind of preparation method of described liniment, it comprises the steps: ethanol extraction secondary Radix seu Caulis Schisandrae Sinensis, Radix Arnebiae (Radix Lithospermi), Rhizoma Polygoni Cuspidati being added 80%, each 1.5-2.0 hour, collect ethanol extract and ethanol extraction filtering residue, ethanol extract concentrating under reduced pressure becomes dry extract, pulverizes for subsequent use; Red Herba violae patrinii, herb Potentillae cryptotaeniae, Herba Lycopodii serrati, Herba Rabdosiae Lophanthoidis, Folium Ilicis Purpureae are decocted with water secondary together with Radix seu Caulis Schisandrae Sinensis, Radix Arnebiae (Radix Lithospermi), Rhizoma Polygoni Cuspidati ethanol extraction filtering residue, collecting decoction, filter, filtrate reduced in volume to relative density is 1.10-1.20 (60 DEG C of survey), adding ethanol makes alcohol content reach 50%, leaves standstill 12 hours, filters, after filtrate recycling ethanol, concentrating under reduced pressure becomes dry extract, pulverizes for subsequent use; After getting polyvinyl alcohol (17-88) and the abundant moistening of sodium carboxymethyl cellulose distilled water, putting heated and stirred in 85-90 DEG C of water-bath is a homogeneous transparent thick liquid; When being cooled to 50-60 DEG C, adding above-mentioned gained dry extract and appropriate distilled water, then add glycerol, ethyl hydroxybenzoate, azone, stir evenly, obtain a brown maroon thickness homogenate, after low temperature sterilization, subpackage and get final product.
Beneficial effect of the present invention is further illustrated below by way of animal experiment and clinical observation test example.
(1) hypersensitive test of Chinese medicine liniment of the present invention
Get healthy albino guinea-pig 30, body weight 280 ± 20g, male and female dual-purpose, reject both sides dorsal body setae before test, every side 3 × 3cm, is divided into test group, blank group and positive controls at random, often organizes 10.Blank group uses the normal saline of 1% to carry out painting hair; Positive controls DNFB, sensitization 1% concentration, excites and uses 0.1% concentration.The liniment that test group gets the embodiment of the present invention 1 is applied to unhairing district, back, every day 1 time, totally 3 times, in latter 14 days of last contact, at back, the same area smears this product 0.1g, at once observes after removing medicine after 6h, and in 1,12,24,48,72h observes with or without anaphylaxis.Blank group and positive controls excite by same method and contact and observe.Result of the test: namely positive controls animal skin occurs localized erythema and slight edema in sensitization after 1 hour, within 24 hours, symptoms of allergic increases the weight of, and have scleroma to be formed, sensitization rate is 100%, all there is not any symptoms of allergic in test group and blank treated animal skin, sensitization rate is 0%.Judge, Chinese medicine liniment of the present invention does not have sensitization.
(2) acute skin irritation test of Chinese medicine liniment of the present invention
Get male 6 of Japan large ear rabbit, body weight 2.5 ± 0.5kg, hair process is shaved to left dorsal skin, adopt the Chinese medicine liniment of the embodiment of the present invention 1, to be applied on the left of animal on skin, opposite side in contrast, adopt blocking test, 4 hours application time, tested material is remained with warm water washing after off-test, after removing tested material, 1h, 12h, 24h, 48h and 72h observe the dermoreaction of the tested district of animal and check plot respectively, and top average is " 0 ", judges that these product are to animal skin nonirritant.Judge, Chinese medicine liniment of the present invention does not have zest to skin.
(3) Chinese medicine liniment of the present invention is to the curative effect of pressure ulcer rat
1 material and method
1.1 models: male and healthy SD rat 60, secondary, clean, body weight 200 ± 25g, is divided into matched group and each 30 of observation group at random.After rat abdominal cavity anesthesia, back depilation sterilization, near rat back spinal column on the right side of lower back, the skin holostrome that runs through being 2cm long is deep to fascia transverse incision, will be placed in skin incision through autoclaving magnetic sheet and sew up, magnetic sheet diameter 13cm, thick 2cm, magnetic force 1500Gs.A block external magnet was acted on rat back magnetic sheet implantation region absorption 2h in postoperative 2nd day and cause ischemia, then remove Magnet Shi Gai district SkBF Reperfu-sion 0.5h, this is a circulation, circulation every day 5, repeats 5d.Ischemia, Reperfu-sion total degree 25 times, Ischemia Time amounts to 50h.Using skin darkening, hardening, the not hemorrhage standard as judging ulcer of acupuncture, namely model is successfully prepared.From modeling success next day every day change dressings, matched group gauze carries out route dressing change, experimental group normal saline cleaning wound surface after change dressings with Chinese medicine liniment of the present invention.
1.2 observation index and detection method: observe wound surface area, healing time, wound surface amount of bacteria changes and basic fibroblast growth factor (bFGF) positive cell number.
Within after modeling the 3rd, 7,14,21 day, detect respectively: draw wound surface with copper sulfate paperboard, record wound surface area change, wound healing time (with wound healing 95% for healing standard);
Detect two and form face amount of bacteria change, within the 3rd, 7,14,21 day after modeling, put to death rat wound surface central tissue to extract respectively, weigh under sterile working and add normal saline grinding after, remake 10 times of serial dilutions and get 10ul in culture medium, in 37 DEG C of environment, cultivate 24-48h, using formula calculates every gram of tissue bacterial number.
Respectively after modeling the 3rd, 7,14,2l days often organizes and puts to death rat 2, get wound surface center granulation tissue, Immunohistochemical Method detects. and with cIAS-l000 image analysis system process acquisition bFGF positive cell number.
1.3 statistical methods: measurement data independent samples t-test, ranked data rank test, all statistics are all carried out in SPSS16.0 software.
2 results
2.1 liang of group Rat Wound Healing times compare: 8 rats that removing midway is put to death.Often organize each 22 wound surface, observation group's wound healing time [(7.88 ± 1.22) d] is significantly shorter than matched group [(15.85 ± l.32) d] (P < 0.05).
After the modeling of 2.2 liang of group rat wound surface amount of bacteria change comparative observation groups under different time wound surface amount of bacteria and matched group there were significant differences (P < 0.05).In Table l.
To show after l: two groups of rat modelings amount of bacteria under different time wound surface (
n=30)
Compare with matched group, * P < 0.05.
After the modeling of 2.3 liang of group rat wound surface different time sections bFGF positive cell number comparative observation group rats 3,7,14d wound surface bFGF positive cell number has significantly different (P < 0.05) from matched group.In table 2.
Table 2: after two groups of rat modelings, wound surface different time sections bFGF positive cell number compares (individual/HP.
n=30)
Compare with matched group, * P < 0.05.
Through observation shows that: liniment of the present invention can provide moistening, warm, an airtight low-oxygen environment for wound surface, facilitate creeping and blood capillary regeneration of rat epithelial cell, obviously shorten the wound repair time.Observation group finds that in the process of changing dressings wound surface is dry, heals under being organized in crust, and better, when changing dressings, liniment adhesion skin of the present invention, is easy to tear off new granulation tissue's growth; And matched group is changed dressings when taking gauze away, the gauze being often difficult to paste on wound surface is separated, and newly granulating sustains damage again, and wound is delayed healing.
(4) clinical observation test
1 data and method
1.1 physical data: man 76 example, female 53 example in 129 routine patients with bedsore; 45 ~ 96 years old age, year mean age (71.2 ± 3.4); Be outside institute and bring pressure ulcer into, pressure ulcer diameter 1.0 ~ 20.5m, average 12.0cm; By decubital ulcer staging scale in " basic nursing operation code ": the second stage of pressure ulcer 68 example, three phase 61 examples; Amputation, paralysis 40 example, extremely feeble, malnutrition 18 example, respiratory failure l2 example, uremia 16 example, apoplexy sequela 43 example.Be divided into matched group and observation group by odd or even number of being admitted to hospital, be respectively 64 examples, 65 routine patients.Two groups of ages, sex, pressure ulcer size, pressure ulcer size are by stages, protopathy compares, and no significant difference (P > 0.05), has comparability.
1.2 diagnostic criterias: the formulation according to " People's Republic of China's traditional Chinese medicine industry standard--Chinese medical disease Standardization of diagnosis and curative effect (YZ/T001.1-94) " decubital ulcer: be apt to occur in the apophysis such as tail sacrum, ridge, elbow ankle and easily suffer oppression and the position that rubs; From the beginning of skin occurring brown erythema, micro-swollen, purple dark edema then, necrosis is festered; During secondary contamination, tissue necrosis is rapid, and pus is dripping, corresponding site Bing Fa Xing core pain; Be more common in the patient of the prolonged illness beds such as stupor, paralysis, fracture, large-area burns.
1.3 administrated methods:
Observation group: the second stage of pressure ulcer: with ANER DIAN sterilization blister and surrounding skin, with asepsis injector suction blister inner product liquid, the Chinese medicine liniment embodiment of the present invention 1 prepared is applied in pressure ulcer wound surface, depending on wound surface improvement degree adjustment liniment consumption and change dressings the time, the every day 1 time of changing dressings; Three phases pressure ulcer: first clean wound surface with hydrogen peroxide, then use normal saline flushing, wipe out slough, the Chinese medicine liniment embodiment of the present invention 1 prepared is applied in pressure ulcer wound surface, changes dressings routinely, within 1 week, is 1 course for the treatment of.
Matched group: after debridement, sterilization skin, do not smear Chinese medicine liniment prepared by the embodiment of the present invention 1, all the other steps are identical with observation group.
All treat 2 courses for the treatment of for two groups.
2 results
2.1 efficacy assessment standards: promulgate " Chinese medical disease Standardization of diagnosis and curative effect " with reference to State Administration of Traditional Chinese Medicine.Recovery from illness: heal completely in skin ulcer face; Effective: wound surface is dry, and skin ulcer reduction of area is little reaches more than 70%; Take a turn for the better: inflammatory exudate reduces, and skin ulcer reduction of area is little by more than 30%; Invalid: inflammatory exudate does not reduce, skin ulcer reduction of area little less than 30% or skin ulcer face expand.Effective percentage=(recovery from illness+effective)/total number of cases × 100%.
2.2 therapeutic outcome
2.2.1 the comparison of two groups of clinical efficacies: observation group's recovery from illness 31 example, effective 27 examples, effective percentage is 89.2%, and apparently higher than matched group 32.8%, difference has statistical significance (P < 0.05).In table 3.
Table 3: the comparative example (%) of two groups for the treatment of clinical efficacies
Compare with matched group, * P < 0.05
2.2.2 two groups of patients fully recover the comparison of healing time of case: treatment group cures required time average out to 6.5 ± 2.7 days, be significantly shorter than matched group (12.9 ± 4.1 days), difference has statistical significance (P < 0.01).In table 4.
Table 4: two groups of patients fully recover case healing time comparison (
)
Compare with matched group, * P < 0.05.
2.2.3 adverse reaction rate: two groups all do not find obvious adverse reaction.
2.2.4 recurrence: the routine patient of observation group 31 carries out tracing observation 3 months, has no recurrent cases.
Clinical research also finds: Chinese medicine composition of the present invention can improve blood circulation, make QI and blood smooth, enhance metabolism, repair the destroyed blood capillary of dredging and microcirculation makes it to provide blood nutrient supply in time, just can reach quickly-healing wound and diminish inflammation and the object of fully recovering.
Liniment adheres to affected part firmly, can completely cut off antibacterial and be conducive to wound surface by self-dissolving to clean, and can ensure that antibacterial cannot invade wound surface, with the growth and breeding avoiding moist environment to promote antibacterial.
In a word, the present invention has following beneficial effect:
Prescription of the present invention is rigorous, compatibility relationship is clear and definite, all medicines 5 are used, there is blood circulation promoting and blood stasis dispelling, the effect of heat-clearing and toxic substances removing, reducing swelling and alleviating pain, anti-inflammation, removing the necrotic tissue and promoting granulation, expansible blood vessel, promotes local blood circulation, improves surrounding tissue nutrition, the rotten tissue of a large amount of necrosis is come off rapidly eliminating, and newly granulate the ramp along with microcirculatory improvement.
Liniment adheres to affected part firmly, can antibacterial be completely cut off and be conducive to wound surface by self-dissolving and clean, by the absorption of skin soft tissue, 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, the rapid microcirculation improving wound surface surrounding tissue, speed regional flow, can promote that remaining epithelial cell tissues grows simultaneously, the nerve impelling retardance to destroy is unimpeded, make QI and blood smooth, the blood capillary that reparation dredging is destroyed and microcirculation make it to provide blood nutrient supply in time, just can reach quickly-healing wound to diminish inflammation and the object of fully recovering.
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.