CN1939426A - Compound medicine for treating skin scald, insult and sore and its preparation - Google Patents
Compound medicine for treating skin scald, insult and sore and its preparation Download PDFInfo
- Publication number
- CN1939426A CN1939426A CN 200510030065 CN200510030065A CN1939426A CN 1939426 A CN1939426 A CN 1939426A CN 200510030065 CN200510030065 CN 200510030065 CN 200510030065 A CN200510030065 A CN 200510030065A CN 1939426 A CN1939426 A CN 1939426A
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- rhizoma polygoni
- skin
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- Medicines Containing Plant Substances (AREA)
Abstract
A Chinese medicine for treating burn, scald, wound and infective sore or ulcer without residual scar is prepared from hairyvein knotweed root, paleaceous knotweed rhizome, giant knotweed rhizome, borneol and the pharmacologically acceptable carrier. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind ofly to treat that skin scalds, the pharmaceutical composition of wound and skin infection and preparation method thereof.
Background technology
This human body of skin is showed most, thus the large tracts of land of easily vulnerable organ to scald the unexpected incidence rate of burn more and more multiple common in modern times, be one of severe challenge of contemporary first aid medicine and pharmacology.Tormenting that the wounded and fatal first close is to have an intense pain and ooze out in a large number and lose body fluid and cause the metabolism disorder of body water salt electrolyte; Taking that second of life closes by force is the serious secondary infection of body surface protection barrier due to damaged, pyemia, and septicemia etc., the toxic and side effects of a large amount of broad ectrum antibiotic application itself and the dysbacteriosis that is caused can bring new danger to patient again.Scald under the burn situation serious, because skin can not regenerate and make skin graft or coated with protecting film, cost dearly, and the cicatrix that therefore causes and scar tissue can cause that the region of interest function limitation is down to disfeaturing; Therefore skin-grafting often can not recover sweat gland and sebaceous gland etc., lacks normal skin function and makes wounded quality of life low, and orthopedic face-lifting thereupon etc. brings sensual extra misery of the wounded and heavy burden economically again.
Therefore this area presses for a kind of product, and infection is only oozed out in its pain relieving at once; Can impel quick incrustation; Can the regenerate skin repair wound surface of tool normal physiological function, preventing from scar and do not have obvious toxic-side effects again; And it is cheap, practical.
Summary of the invention
The present invention aims to provide a kind of pharmaceutical composition, it can immediately end severe pain, ends oozing of blood, end seepage, infection, fast rapid regeneration is provided the skin of normal function under crust scar protective layer in a short time, and preventing from scar, has exempted the misery of shaping in the future and heavy financial burden; Another object of the present invention provides this preparation of drug combination method.
In one aspect of the invention, a kind of pharmaceutical composition is provided, it contains the necessary component that is selected from down group: the Borneolum Syntheticum of the Rhizoma Polygoni Paleachi of the Radix Polygoni Ciliinerve of 30-99 parts by weight, 3-15 parts by weight, the Rhizoma Polygoni Cuspidati of 5-20 parts by weight, 3-15 parts by weight, and the pharmaceutically acceptable carrier of 50-1000 parts by weight.
In another preference, it contains the Radix Polygoni Ciliinerve of 15-40 parts by weight, the Rhizoma Polygoni Paleachi of 5-12 parts by weight, the Rhizoma Polygoni Cuspidati of 5.5-15 parts by weight, the Borneolum Syntheticum of 5-10 parts by weight.
Preferred, it contains: the Borneolum Syntheticum of the Rhizoma Polygoni Paleachi of the Radix Polygoni Ciliinerve of 18-30 parts by weight, 6-10 parts by weight, the Rhizoma Polygoni Cuspidati of 6-10 parts by weight, 6-8 parts by weight.
In another preference, above-mentioned pharmaceutical composition, also contain following component: Radix Salviae Miltiorrhizae, Cortex Moutan, Sanguis Draxonis, process Corium elephatis, or its mixture.
Parts by weight wherein be Cortex Moutan, the 3-15 parts by weight of Radix Salviae Miltiorrhizae, the 3-15 parts by weight of 3-15 parts by weight Sanguis Draxonis, 1-8 parts by weight process Corium elephatis or its mixture.The Radix Salviae Miltiorrhizae of preferred 4-8 parts by weight; The Cortex Moutan of 3-8 parts by weight; The Sanguis Draxonis of 3-8 parts by weight; The 1-3 parts by weight process Corium elephatis or its mixture.
In another aspect of this invention, provide a kind of external Fu Ba agent, it comprises the above-mentioned pharmaceutical composition of 5-7 parts by weight and the 3-5 parts by weight substrate of making up a prescription; The described substrate of making up a prescription is the colloid solution of 1-4% (w/w) for chitosan content.
In another aspect of this invention, a kind of above-mentioned preparation of drug combination method is provided, it comprises step: the medical material of the Borneolum Syntheticum of the Rhizoma Polygoni Cuspidati of the Rhizoma Polygoni Paleachi of the Radix Polygoni Ciliinerve of 30-99 parts by weight, 3-15 parts by weight, 5-20 parts by weight, 3-15 parts by weight is mixed with the pharmaceutically acceptable carrier of 50-1000 parts by weight, obtain pharmaceutical composition.
In another aspect of this invention, provide this external Fu Ba the preparation method of agent, comprised step:
A is with the Radix Polygoni Ciliinerve of 30-99 parts by weight, the Rhizoma Polygoni Paleachi of 3-15 parts by weight, the Rhizoma Polygoni Cuspidati of 5-20 parts by weight, the Borneolum Syntheticum of 3-15 parts by weight, and the Radix Polygoni Ciliinerve of the pharmaceutically acceptable carrier of 50-1000 parts by weight or 30-99 parts by weight, the Rhizoma Polygoni Paleachi of 3-15 parts by weight, the Rhizoma Polygoni Cuspidati of 5-20 parts by weight, the Borneolum Syntheticum of 3-15 parts by weight, add Cortex Moutan, the 3-15 parts by weight of Radix Salviae Miltiorrhizae, the 3-15 parts by weight of 3-15 parts by weight Sanguis Draxonis, 1-8 parts by weight process Corium elephatis or its mixture medical material powder process;
B dissolves chitosan with the 0.5-3% glacial acetic acid;
C is an amount of with animal and plant fat, makes the colloid solution that chitosan content is 1-4% (w/w), is the substrate of making up a prescription.
D gets the 3-5 parts by weight substrate of making up a prescription, and the powder of calling in 5-7 parts by weight step a gained is mixed into cream, and sterilization filling uses.
In another preference above-mentioned all medicines except that Borneolum Syntheticum, Sanguis Draxonis, process the Corium elephatis, all need fully to clean, section or segment dry or dry and meet Chinese crude drug to water content and concoct country or origin criterion behind the airing.Get the clean medical material mixing of this eight flavor in the prescription ratio then, coarse powder, fine powder, superfine powder successively, particle diameter is more than or equal to 5 microns smaller or equal to 50 microns.
In another preference, described animal and plant fat is Oleum sesami or oleum lini or perilla oil or Oleum Camelliae or Adeps melis or ermine oil or white vaseline etc.
In another preference with microwave or gamma-radiation irradiation sterilization.
In another aspect of this invention, provide described external Fu Ba agent to scald burn, wound or/and the application in the medicine of the skin infection that causes because of antibacterial, viral infection at preparation treatment skin.
In another aspect of this invention, a kind of purposes of mixture is provided, described mixture is by the Radix Polygoni Ciliinerve of 30-99 parts by weight, the Rhizoma Polygoni Paleachi of 3-15 parts by weight, the Rhizoma Polygoni Cuspidati of 5-20 parts by weight, the Borneolum Syntheticum of 3-15 parts by weight constitutes or by the Radix Polygoni Ciliinerve of 30-99 parts by weight, the Rhizoma Polygoni Paleachi of 3-15 parts by weight, the Rhizoma Polygoni Cuspidati of 5-20 parts by weight, the Borneolum Syntheticum of 3-15 parts by weight, the Radix Salviae Miltiorrhizae of 3-15 parts by weight, the Cortex Moutan of 3-15 parts by weight, the Sanguis Draxonis of 3-15 parts by weight, the Corium elephatis of processing of 1-8 parts by weight constitutes, it is characterized in that described mixture is used for preparation treatment skin and scalds burn, wound is or/and because of antibacterial, viral infection and the medicine of the skin infection that causes.
Description of drawings
Fig. 1: rat III degree scalding model skin
Fig. 2: rat III degree scalding model skin
Fig. 3: the Ba agent is applied in the external that the embodiment of the invention 5 makes, and to call investigational agent in the following text B ♂ 3 rat III degree is scalded complete healing skin
Fig. 4: investigational agent is scalded complete healing skin to B ♀ 2 rat III degree
Fig. 5: investigational agent is scalded basic healing skin to B ♂ 1 rat III degree
Fig. 6: moist expose burn ointment is scalded basic healing skin to C ♀ 3III degree
Fig. 7: moist expose burn ointment positive controls C ♂ 4 burned rats skin infections
Fig. 8: excipient control group A ♀ 3 rat III degree scald infection skins
Fig. 9: rat III degree scalded skin
Figure 10: rat III degree scalded skin coating photo
Figure 11: control rats skin healing situation
Figure 12: investigational agent group rat skin healing state
Figure 13: positive controls rat skin healing state
The specific embodiment
The inventor is through extensive and deep discovering, the Chinese medicine compound of effect such as employing has heat-clearing and toxic substances removing, hemostatic analgesia, pleasant removing dampness, promoting blood circulation to remove blood stasis, remove the rotten and let fresh grow, in can effectively treating, severe scalds burn, especially dark II degree and III degree are seriously scalded burn and have excellent curative.Do not need the special treatment environment, use in time that pharmaceutical composition provided by the invention can immediately end severe pain, ends seepage, infection, fast rapid regeneration is provided the skin of normal function and preventing from scar under crust scar protective layer in a short time.
As used herein, term " necessary component " refers to necessary Chinese medicine medical material, i.e. Radix Polygoni Ciliinerve (RadixPplygoni Cillinervis), Rhizoma Polygoni Paleachi (Rhizoma Polygoni Palecei), Rhizoma Polygoni Cuspidati (RhizomaPolygoni Cuspidati) and Borneolum Syntheticum (Blumea Balsamifera (L) D.c) or (BorneolumShyntheticum).
Radix Polygoni Ciliinerve is polygonaceae plant floating and thready pulse knotweed { Polygonum cillinerve (Nakai) Ohwi[Pleuropterus cillinervis Nakai; Polygonum multiflorum Thunb.Var.cillinerve (Nakai) Steward] } fibrous root.Property of medicine bitter in the mouth, little puckery, cool in nature, return lung, large intestine, Liver Channel.Active ingredient has Radix Aristolochiae Kaempferi first element (emodin Emodin), Radix Aristolochiae Kaempferi second element (physcione Physcion) and emodin-8-O-β-D-glycoside; Also contain wine plant glycoside and anthraquinones, chrysophanol, chrysophanic acid etc.
Rhizoma Polygoni Paleachi is polygonaceae plant Rhizoma Polygoni Paleachi [Polygonum Paleaceum Wall] rhizome.Bitter in the mouth, suffering, (the southern regions of the Yunnan Province book on Chinese herbal medicine etc. claim its bitter in the mouth, suffering, little puckery, slightly warm in nature) cold in nature is to be first ministerial drug in the pharmaceutical composition provided by the invention.
Rhizoma Polygoni Cuspidati is polygonaceae plant Rhizoma Polygoni Cuspidati { Polygonum Cuspidatum Sieb.etZucc.[P.Reynoutria Makino; Reynoutria Japonica Houtt] } rhizome.The property of medicine is slightly cold, and liver, gallbladder meridian are returned in bitter in the mouth, acid.Its chemical analysis mainly is that Radix Et Rhizoma Rhei anthracene Kun class etc. is very complicated.The present invention assists to be all Radix Polygoni Ciliinerve, the Rhizoma Polygoni Paleachi of Polygonaceae with it for another ministerial drug, for safety specially good effect ground cures serious boiling hot burn, skin trauma or/and the skin infection skin infection lays the foundation.
The Borneolum Syntheticum property of medicine is slightly cold, suffering, and hardship, flavor delicate fragrance, GUIXIN spleen lung meridian is for assistant of the present invention makes it medicine.
As used herein, term " component " refers to the Chinese medicine medical material beyond the necessary Chinese medicine medical material, i.e. Radix Salviae Miltiorrhizae (Radix Salviae Miltiorrhizae or Radix Salviae P.), Cortex Moutan (CortexMoutan), Sanguis Draxonis (Sanguis Draxonis) or process Corium elephatis (Coriun Elephatis) or its combination.
Radix Salviae Miltiorrhizae is the root of labiate Radix Salviae Miltiorrhizae [Salvia Miltiorrhiza Bunge] and Salvia przewalskii [Saliva Przewalskii Maxim.].The property of medicine is cold, bitter in the mouth, GUIXIN, pericardium, Liver Channel.It is the flavonoid of representative, a large amount of Diterpenes that its main chemical has with the TANSHINONES, also have triterpenes and sterols all is fat-soluble composition, also has water miscible danshensu etc.
Cortex Moutan is the root bark of Paeoniaceae plant Paeonia suffruticosa [Paeonia Suffruticosa Andr..].The property of medicine is slightly cold, bitter in the mouth, suffering, and GUIXIN, liver, kidney channel, its main chemical is a paeonol etc.
Sanguis Draxonis is that the resin that the fruit of palmitic acid section plant Sanguis Draxonis [Daemonorops Draco BL] oozes out processes from strand.The property of medicine is sweet, and is salty, flat, GUIXIN, Liver Channel.
Process Corium elephatis and be the dry skin of the process of preparing Chinese medicine after the elephant death, the property of medicine is sweet, and is salty, and temperature is returned urinary bladder channel.
As used herein, term " basically by ... constitute " refer in compositions, be necessary the component except containing, also can contain a spot of and not influence the submember and/or the impurity of effective ingredient.For example, can contain antioxidant in case oxidation, and other this areas additive commonly used.Usually Radix Polygoni Ciliinerve (Radix Pplygoni Cillinervis), Rhizoma Polygoni Paleachi (Rhizoma Polygoni Palecei), Rhizoma Polygoni Cuspidati (Rhizoma Polygoni Cuspidati) and natural Broneolum Syntheticum (or Borneolum Syntheticum) (BlumeaBalsamifera (L) D.c) or (Borneolum Shyntheticum) account at least 55% of whole Chinese medicine medical material weight, preferably at least 70%, more preferably at least 95%.
As used herein, term " substrate of making up a prescription " refers to be used for the carrier of external Fu Ba agent administration, comprises that chitosan content is colloid solution, the Cera Flava of 1-4% (w/w).In the substrate of making up a prescription of the deposited Ba agent of external, can contain water, acetic acid.Also may there be complementary material in these substrate of making up a prescription, as wetting agent or emulsifying agent, pH buffer substance etc.
As used herein, term " pharmaceutically acceptable carrier " refers to be used for the treatment of the carrier of agent administration, comprises various excipient and diluent.This term refers to some medicament carriers like this: they itself are not necessary active component, and do not have undue toxicity after using.Suitable carriers is well known to those of ordinary skill in the art.(Mack Pub.Co. can find discussing fully about pharmaceutically acceptable excipient in N.J.1991) at Remington ' s Pharmaceutical Sciences.Acceptable carrier can contain liquid on combination of Chinese medicine is learned, as water, saline, glycerol and ethanol.In addition, also may there be complementary material in these carriers, as wetting agent or emulsifying agent, pH buffer substance etc.Come from Radix Polygoni Ciliinerve (Radix PplygoniCillinervis), Rhizoma Polygoni Paleachi (Rhizoma Polygoni Palecei), Rhizoma Polygoni Cuspidati (Rhizoma PolygoniCuspidati), Borneolum Syntheticum (Blumea Balsamifera (L) D.c) or (BorneolumShyntheticum), Radix Salviae Miltiorrhizae (Radix Salviae Miltiorrhizae or Radix Salviae P.), Cortex Moutan (Cortex Moutan), Sanguis Draxonis (Sanguis Draxonis) and process other inessential compositions (for example other complementary medical materials) outside the Corium elephatis (CoriunElephatis) is also included within the definition of pharmaceutically acceptable carrier.
Burn and scald or boiling hot burn are that the pathogenic fire pyretic toxicity is externally invaded due to the excessive injured skin, for making the reparation of skin trauma, must only ooze out the heat-clearing and toxic substances removing removing heat from blood with hemostasis and pain-relieving is elder generation, the while blood circulation promoting and blood stasis dispelling, with unimpeded local microcirculation, make supply continuously repair the required abundant nutrition material of skin, stop the generation of collagen fiber simultaneously again as far as possible, even can dissolve early and will generate or the collagen fiber of harsh one-tenth, prevent or reduce as far as possible the generation of scar tissue.All these skin repair activities are all having good permeability, and are nontoxic, nonirritant, and no anaphylaxis is carried out under the lubrication protection layer that can degrade voluntarily, has completely cut off the infringement of further external poison evil (as antibacterial, virus etc.), therefore need not special clean ward.
Each component mutual reinforcement between usefulness mutually amounts to above-mentioned target in the pharmaceutical composition provided by the invention, has received magical effect.
In the present composition, by weight, the appropriate proportioning of four kinds of necessary medical materials is:
10-50 parts by weight, preferably 15-40 parts by weight, the more preferably Radix Polygoni Ciliinerve of 18-30 parts by weight;
3-15 parts by weight, preferably 5-12 parts by weight, the more preferably Rhizoma Polygoni Paleachi of 6-10 parts by weight;
5-20 parts by weight, preferably 5.5-15 parts by weight, the more preferably Rhizoma Polygoni Cuspidati of 6-10 parts by weight;
3-15 parts by weight, preferably 5-10 parts by weight, the more preferably natural Broneolum Syntheticum of 6-8 parts by weight.
The material of surplus is pharmaceutically acceptable carrier, for example excipient, stabilizing agent, wetting agent etc.
For making the better therapeutic effect of preparation tool, the proportioning of the medical material that also can add in the present composition is:
3-15 parts by weight, the preferably Radix Salviae Miltiorrhizae of 5-12 parts by weight;
3-15 parts by weight, the preferably Cortex Moutan of 3-8 parts by weight;
3-15 parts by weight, the preferably Sanguis Draxonis of 3-8 parts by weight;
The 1-8 parts by weight, preferably the 3-6 parts by weight processs Corium elephatis.
In another aspect of this invention, provide a kind of external Fu Ba agent, it comprises above-mentioned necessary component and the substrate of making up a prescription, and also can comprise other Chinese crude drug.
One embodiment of the present of invention provide above-mentioned external Fu Ba the preparation method of agent, the steps include:
A is with above-mentioned medical material fill a prescription in proportion mixing, powder process;
B dissolves chitosan with the 0.5-3% glacial acetic acid;
C is an amount of with animal and plant fat, makes the colloid solution that chitosan content is 1-4% (w/w), is the substrate of making up a prescription.
D gets the 3-5 parts by weight substrate of making up a prescription, and the powder of calling in 5-7 parts by weight step a gained is mixed into cream, and sterilization filling uses.
In another preference above-mentioned all medicines except that Borneolum Syntheticum, Sanguis Draxonis, process the Corium elephatis, all need fully to clean, section or segment dry or dry and meet Chinese crude drug to water content and concoct country or origin criterion behind the airing.Get clean medical material mixing in the prescription ratio then, coarse powder, fine powder, superfine powder successively, particle diameter is more than or equal to 5 microns smaller or equal to 50 microns.
Animal and plant fat described in another preference can be selected Oleum sesami or oleum lini or perilla oil or Oleum Camelliae or Adeps melis or ermine oil or white vaseline etc. for use.
In another preference, the mastic of steps d gained was left standstill 72 hours, sterilize after the no lamination.
In another preference, steps d is with microwave or gamma-radiation irradiation sterilization.
External Fu Ba agent content of dispersion provided by the invention is 50-70% (w/w), and it is required and decide that patient's usage and dosage should be wound surface.
Pharmaceutical composition provided by the invention, adopt the ultra micro differentiation technique, call in after the substrate of making up a prescription in right amount makes Fu Ba agent, coating is early executed by the serious skin wound that scalds burn etc. to control under common treatment environment, and curative effect outclass all on the market domestic and international similar topical agents at present.The Ba agent is applied in external provided by the invention has distinguished curative effect equally to other wound of skin, skin infection, decubital ulcer, infection etc.
Major advantage of the present invention is:
1, to the large tracts of land rats after severe scald burn, burn, burn, under common treatment condition, after suiting the medicine to the illness debridement treatment, routine use external provided by the invention to apply the Ba agent, can pain relieving only ooze out, infection, the skin repair wound surface of fast rapid regeneration tool normal physiological function does not stay cicatrix, has exempted the painful and economic heavy burden of shaping thereafter;
2, indication of the present invention is wide, the skin infection that causes to serious boiling hot burn such as the skin that causes because of heat, power, electricity, chemical mordant etc., wound or/and because of antibacterial, viral infection.Especially the chronic skin infection of prolonged skin of not healing, decubital ulcer etc. also tool are very imitated;
3, it is cheap to use this product medical expense, stay sequela hardly, thereby prognosis is splendid.
Further set forth the present invention below in conjunction with embodiment.Should be understood that these embodiment only to be used to set forth the present invention and be not used in restriction the present invention.In an embodiment, percentage ratio is weight percentage, and umber is parts by weight, unless stated otherwise.
Embodiment 1-4
Pharmaceutical compositions
| Embodiment 1 | Embodiment 2 | Embodiment 3 | | |
| Radix Polygoni Ciliinerve | 40 | 35 | 90 | 45 |
| Rhizoma Polygoni Cuspidati | 15 | 50 | 15 | 18 |
| | 10 | 50 | 10 | 15 |
| | 10 | 5 | 12 | 8 |
| Radix Salviae Miltiorrhizae | 9 | 6 | 10 | |
| | 6 | 6 | 10 | |
| | 6 | 5 | ||
| Process Corium elephatis | 4 | 3 | ||
| | 10 | 20 | ||
| | 10 | 17 |
Embodiment 5-8
Preparation external Fu Ba agent
(1) except that Sanguis Draxonis, process the Corium elephatis, fully clean each medical material, section or segment dry or dry and meet Chinese crude drug to water content and concoct country or origin criterion behind the airing;
(2) take the clean medical material mixing of respectively distinguishing the flavor of in the ratio of embodiment 1-4 respectively, coarse powder, fine powder, superfine powder be to particle diameter≤30 μ m successively, and be standby;
(3) the average substrate of making up a prescription:
With 1% glacial acetic acid (AR) chitosan (content 90%) is dissolved by 99% saturated concentration.The reuse Oleum sesami is an amount of, makes the colloid solution that chitosan content is 2% (w/w), is the standby substrate of making up a prescription.
(4) get the 3.8 parts by weight substrate of making up a prescription and call in 6.2 parts by weight Chinese crude drug mixing superfine powder, fully mixing makes into the even matter of paste, leaves standstill 72 hours no laminations, fill, and microwave or gamma-radiation irradiation sterilization are sterilized.
Embodiment 9
The experiment of rat III degree wound tissue healing influence
1. materials and methods
1.1 be subjected to the reagent thing:
1, the Ba agent is applied in the external that makes of embodiment 5, to call investigational agent in the following text;
2, moist expose burn ointment: the Chinese medicine compound externally used paste, produce lot number: 20050206 by Beijing bright traditional Chinese medical science burn institute, Shantou Special Economic Zone MEIBAO pharmaceutical factory;
3, excipient: form by Oleum sesami.Provide by Chinese medicine preparation research department, institute of Chinese materia medica, Hunan Inst of Traditional Chinese Medicine.
1.2 main agents and instrument
1, HM325 type microtome is a German Cai Shi company product.
2, MC80DS microscope camera chain is a German Cai Shi company product.
3, sodium sulfide: prolong air slaking chemical reagent work by Changsha and give birth to factory, lot number; 20040801.
1.3 laboratory animal
1, SD system cleaning level rat is provided by west, Shanghai pul-Bi Kai laboratory animal company limited.Credit number: SCXK (Shanghai) 2003-0002, the quality certification number is 0005814
The laboratory animal environmental facility quality certification number: moving No. 027 of Hunan.
1.4 animal grouping:
1, excipient matched group: animal gives excipient in contrast.
2, investigational agent group: animal gives investigational agent.
3, positive controls: animal gives moist expose burn ointment as positive control.
1.5 statistical analysis technique
Experimental data is represented with mean+SD.The significance test of enumeration data group difference adopts the X2 check, and measurement data adopts the t check.
2. result of the test
2.1 investigational agent is to the promoting healing effect experiment of rat III degree scald wound
2.1.1 experimental technique: get 36 of SD rats, male and female half and half, body weight 172 ± 13g, animal is divided into excipient matched group, investigational agent group and moist expose burn ointment positive controls immediately.Slough the rat dorsal body setae with 8% sodium sulfide, the about 30cm2 of area.Behind the 24h, under ether inhalation anesthesia, rat back depilation district is gone into 100 ℃ of water baths through aperture for the 4cm circular trough continue 15 seconds, to cause III degree scalding model [1], 2 rat bark fetching skins of every group of execution carry out the pathology detection behind the modeling 12h.The modeling rat is divided into 3 groups, and 10 every group, after finishing, grouping measures wound area, and each treated animal is coated with the corresponding reagent that is subjected on wound surface subsequently, and once a day later on, successive administration 25 days is observed the wound healing situation every day.Scald back primary trauma area according to Nagelschmidt method [2] record, method claims the weight of the identical scraps of paper of 1cm2 simultaneously for taking by weighing measured area scraps of paper weight, is converted into area with this weight.Used in the 10th day, the 15th day, the 25th day with method mensuration wound area in the burn back, calculate healing wounds area.Put to death animal in the time of the 25th day in test, get wound surface skin and do pathological examination.Each is organized the data difference significance test and adopts the t check.
2.1.2 experimental result:
1, perusal result shows:
(1) investigational agent group burned rats position skin recovers obviously to want fast than excipient matched group and positive controls rat, and have 2 investigational agent group rats wound surface in the time of 25 days almost completely to recover normally, wound surface skin grows hair and excipient matched group and positive controls more all significant difference (P＜0.01).
(2) investigational agent group rat wound surface does not have the infection phenomenon, and the excipient matched group has 5 rats, and positive controls has 2 rat wound surface in various degree infection phenomenon all to occur, with excipient matched group and positive controls significant difference (P＜0.01) is arranged more all.
(3) The average healing of the short wound tissue healing of investigational agent is shorter than moistening burn cream.
Show 1:20 days investigational agents to heal the fully influence (n=10) of (becoming mildewed) of burned rats position skin
| Group | The number of rats that heals fully (only) | Complete healing rate (%) |
| Excipient matched group investigational agent group moist expose burn ointment positive control | 0 2 0 | 0 20**## 0 |
Compare with the excipient matched group: * * P＜0.01
Compare with the moist expose burn ointment positive control: ##P＜0.01
2, observed result shows under the mirror: after the modeling behind the 12h bark fetching skin carry out pathology and detect and be shown as rat III degree scalded skin pathological change (Fig. 1, Fig. 2), illustrate that modeling is successfully.Behind the coating 25 days, the investigational agent group has 2 rat wound surface dermal pathology sections to be shown as healing change (Fig. 3, Fig. 4) fully, and 8 is that basic healing changes (Fig. 5).8 of moist expose burn ointment positive controls rats change (Fig. 6) for being basic healing, and 2 are skin infection change (Fig. 7).5 of excipient control rats are that basic healing changes, and 5 are skin infection change (Fig. 8).
Show 2:25 days investigational agents to the comparison (n=10) of healing substantially of burned rats position skin
| Group | Basic healing number of rats (only) | Complete healing rate (%) |
| Excipient matched group investigational agent group moist expose burn ointment positive control | 5 10 8 | 50 100**## 80 |
Compare with the excipient matched group: * * P＜0.01
Compare with the moist expose burn ointment positive control: ##P＜0.05
3, calculating healing wounds area result shows: when the 10th day, the 15th day and the 25th day, the healing wounds area wants big than the excipient matched group is remarkable to investigational agent group skin after administration, and the two compares＜0.01.Investigational agent group rat healing wounds area is also wanted big (seeing Table 3) than positive controls.
Table 3: the promoting healing effect that investigational agent is scalded rat III degree (n=10 x ± SD)
| Group | Primary trauma area (cm 2) | Healing wounds area (cm2) | ||
| The 10th day | The 15th day | The 25th day | ||
| The contrast of excipient matched group investigational agent group moist expose burn ointment | 11.53±0.58 11.44±0.76 11.12±0.71 | 1.68±0.51 3.42±0.87** 3.07±0.96** | 2.52±0.97 6.75±1.68** 5.23±1.74** | 3.57±1.63 8.04±2.42** 6.93±2.10** |
Compare * * P＜0.01 with the excipient matched group
3. conclusion (of pressure testing)
Investigational agent can significantly promote the healing of rat III degree scald wound, prevents the infection of wound surface, shortens the healing time of wound surface.And effect is better than the positive control drug moist expose burn ointment.With the burn medicine of our former studies relatively, this medicine with can prevention infection, comparatively fast promote that wound healing is its characteristics.The excipient suggestion adopts Cera Flava, lanoline, Oleum Camelliae to form, and its effect may be better.
The result shows: investigational agent can significantly promote the healing of rat III degree scald wound, prevents the infection of wound surface, shortens the healing time of wound surface.
Embodiment 10-12
The investigational agent that the prepared external Fu of embodiment 6-8 Ba agent replaces embodiment 5 to make is tested by the mode of embodiment 9, as a result unanimity.
Embodiment 13
Investigational agent pharmacodynamics test scalded skin pathology detection result
With the external Fu Ba agent that embodiment 5 makes, promptly following alleged investigational agent is tested.
Censorship skin is drawn materials after 10% formalin fixed, the routine paraffin wax embedded section, and H.E dyeing, light microscopic is observed down, and the result is as follows:
1. rat III degree scalded skin
12h bark fetching skin after the burned rats modeling.Pathological section shows that skin does not have epithelium and covers, and the deep muscular tissue has focal necrosis, and leukocyte infiltration is arranged between flesh, meets III degree scalded skin wound surface.
2. investigational agent is controlled rat III degree and is scalded complete healing skin
Investigational agent group coating 25 days, 2 are almost completely recovered rat (B ♂ 3, B ♀ 2) bark fetching skin, and it is normal that pathological section is shown as each layer of skin structure, epidermis, corium, subcutaneous tissue clear in structure, the normal epithelium of re-epithelialize layer will approach.Meet III degree scalding healing skin.
3. rat III degree is scalded basic healing skin
The basic healing skin of investigational agent group (B ♂ 1) and moist expose burn ointment positive controls (C ♀ 3).Coating is the bark fetching skin after 25 days, and pathological section shows that skin has epithelium to cover, and imperfect, the re-epithelialize thickness differs, and goes up the subcutaneous all residual granulation tissue that has.Meet the III degree and scald basic healing skin.
4.III degree scald infection skin
25 days bark fetching skins behind excipient matched group (A ♀ 3), moist expose burn ointment positive controls (C ♂ 4) the skin infection coating.Pathological section shows exfoliation, and no epidermis covers, and the surface is with inflammatory exudate and a little granulation tissue hyperplasia, and subcutaneous tissue Mild edema and leukocyte infiltration meet III degree scalded skin infective wound surface.
Embodiment 14-16
The investigational agent that the prepared external Fu of embodiment 6-8 Ba agent replaces embodiment 5 to make is tested by the mode of embodiment 13, as a result unanimity.
Embodiment 17
Investigational agent pharmacodynamics test scalded skin perusal result
With the external Fu Ba agent that embodiment 5 makes, promptly following alleged investigational agent is tested.
1. rat III degree scalded skin: rat III degree is scalded photo (Fig. 9) after the modeling
2. rat III degree scalding model animal wound surface coating photo (Figure 10)
3. rat III degree wound tissue healing situation photo
(1) excipient control rats III degree wound tissue healing situation: the animal scalded skin area that do not heal is bigger, and as seen the part wound surface infects.(Figure 11)
(2) investigational agent group rat III degree wound tissue healing situation: the animal scalded skin wound surface area that do not heal is less, and the part rat skin has grown hair.(Figure 12)
(3) moist expose burn ointment positive controls rat III degree wound tissue healing situation: the animal scalded skin does not heal area will be greatly than investigational agent treated animal wound surface, and as seen the part wound surface infects.(Figure 13)
Embodiment 18-20
The investigational agent that the prepared external Fu of embodiment 6-8 Ba agent replaces embodiment 5 to make is tested by the mode of embodiment 17, as a result unanimity.
Embodiment 21
Boiling hot burn waits to control tests example
Below used all be the external Fu Ba agent that embodiment 5 makes, promptly following alleged investigational agent.
Congratulate * *, people from Hunan, woman, 38 years old, because of child's naughtiness, the firecracker that to light is lost in the paint kettle and is exploded, and causes the paint that ignites and splashes and just be stained with in paintwork she, causes its shirtfront of burn, back, both hands arm and women's head-ornaments portion reach 45% left and right sides TBS, wherein dark II ° about 25%, III ° about 6%.Through using the investigational agent external application for curing, pain relieving at once, fill a vacancy once a day and in time moistening it, add quiet cefazolin sodium 2g, 8 hours once, treated 7 days, recovery from illness does not stay obvious cicatrix after 25 days.
Du * father and son, people from Hunan, father 49 years old, sub-Du Ping 21 years old, the Yin Duping electric welding still has the car oil case of Residual oil explosion caused, causes petrol burn, his father removes burn women's head-ornaments portion, and outside right arm and the right front breast, the fuel tank iron plate that thigh is also blown up gives a discount, its sub-Du Ping burn is more serious, because of treatment elsewhere earlier, lifts when seeking medical advice again after invalid, its shirtfront and two thigh front sides, two knee joints, two shank tops and both hands arm are the obvious suppurative infection of burn wound more than II °, announcement can not guarantee to cure the no cicatrix in back.After the normal saline debridement, use the investigational agent external application for curing, at once pain relieving, fill a vacancy once a day and in time moistening it, add cefradine 0.5g, 6 hours once, treated 7 days, recovery from illness only stays unconspicuous thin leveling scar after 15 days, and his father only uses this secret recipe ointment external application for curing, fully recover about the Ninth Heaven, do not stay obvious cicatrix.
Week * *, people from Sichuan, the man, 28 years old, the shed that collapses in repairing farm, typhoon heavy rain sky, the high-tension bus-bar that touches lodging accidentally causes high-voltage electric shock and burns wound, has infected when the countryside is sent here, visible its right hand metacarpophalangeal joints and second articulations digitorum manus have burnt to such an extent that expose white tendon after the normal saline debridement, and its right hand function that can not guarantee of announcement can be recovered fully.Oral administration cefradine 0.5g, 6 hours are once, treat 7 days, fully recover after 20 days with the investigational agent external application, and right hand function is recovered fully, does not stay cicatrix.
Woods * *, Cantonese, man, 10 years old, the pupil carried two big bottles of boiled water because of both hands and falls down on stair and cause the vacuum flask explosion and scald two lower limb fronts, shallow II ° is main, removes the broken bubble of cleaning wound surface and extracts transudate, oral cefradine 0.25g, 6 hours once, treats 3 beyond the highest heavens, with the MEIBAO board soak Scald Ointment coating wound surface of professor's Xu Rongxiang invention, wound surface is not felt any better after three days, and anti-degree of taking a favourable turn infects, and promptly changes the investigational agent external application, the back recovery from illness of one week does not stay cicatrix.
Open * *, people from Jilin, the woman, 48 years old, because of with the passing of time the bed of cerebral thrombosis apoplexy causes decubital ulcer between buttocks and anus, all over there is no effect with various external-applied ointments on the market, pain was hard to bear and weep, and gives the investigational agent coating, spends the night and promptly heals, and being exclaimed is " refreshing medicine ".
TCL opens the mother of * *, and right lower jawbone advanced carcinoma ulcer stops to corrode behind the coating investigational agent.Do not know repentant morning and lose early the chance of using.
Poplar * * adds the nationality Chinese, the man, and 43 years old, right forelock border Xi herpes to the right eye applied investigational agent that night, and the basic controlling of spending the night was fully recovered after a couple of days.
All quote in this application as a reference at all documents that the present invention mentions, just quoted as a reference separately as each piece document.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after having read above-mentioned teachings of the present invention, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Claims (10)
1. a pharmaceutical composition is characterized in that, contains the necessary component that is selected from down group;
The Radix Polygoni Ciliinerve of 30-99 parts by weight;
The Rhizoma Polygoni Paleachi of 3-15 parts by weight;
The Rhizoma Polygoni Cuspidati of 5-20 parts by weight;
The Borneolum Syntheticum of 3-15 parts by weight;
And the pharmaceutically acceptable carrier of 50-1000 parts by weight.
2. pharmaceutical composition as claimed in claim 1 is characterized in that it contains:
The Radix Polygoni Ciliinerve of 40-80 parts by weight;
The Rhizoma Polygoni Paleachi of 5-12 parts by weight;
5.5-15 the Rhizoma Polygoni Cuspidati of parts by weight;
The Borneolum Syntheticum of 5-10 parts by weight.
3. pharmaceutical composition as claimed in claim 1 is characterized in that it contains:
The Radix Polygoni Ciliinerve of 50-70 parts by weight;
The Rhizoma Polygoni Paleachi of 6-10 parts by weight;
The Rhizoma Polygoni Cuspidati of 6-10 parts by weight;
The Borneolum Syntheticum of 6-8 parts by weight.
4. pharmaceutical composition as claimed in claim 1 is characterized in that, also contains following component: pellet
Ginseng, Cortex Moutan, Sanguis Draxonis, process Corium elephatis, or its mixture.
5. pharmaceutical composition as claimed in claim 4 is characterized in that it contains:
The Radix Salviae Miltiorrhizae of 3-15 parts by weight;
The Cortex Moutan of 3-15 parts by weight;
The Sanguis Draxonis of 3-15 parts by weight;
The 1-8 parts by weight process Corium elephatis;
Or its mixture.
6. the Ba agent is applied in an external, it is characterized in that, comprises 5-7 parts by weight claim 1 or 4 described pharmaceutical compositions and the 3-5 parts by weight substrate of making up a prescription; The described substrate of making up a prescription is the colloid solution of 1-4% (w/w) for chitosan content.
7. described preparation of drug combination method of claim 1 is characterized in that it comprises step:
The medical material of the Borneolum Syntheticum of the Rhizoma Polygoni Cuspidati of the Rhizoma Polygoni Paleachi of the Radix Polygoni Ciliinerve of 30-99 parts by weight, 3-15 parts by weight, 5-20 parts by weight, 3-15 parts by weight is mixed with the pharmaceutically acceptable carrier of 50-1000 parts by weight, obtain pharmaceutical composition.
8. the preparation method of Ba agent is applied in an external as claimed in claim 6, comprises step:
A is with the medical material powder process in claim 1 or 4;
B dissolves chitosan with the 0.5-3% glacial acetic acid;
C is an amount of with animal and plant fat, makes the colloid solution that chitosan content is 1-4% (w/w), is the substrate of making up a prescription.
D gets the 3-5 parts by weight substrate of making up a prescription, and the powder of calling in 5-7 parts by weight step a gained is mixed into cream, and sterilization filling uses.
9. external Fu Ba as claimed in claim 6 agent is scalded burn, wound or/and the application in the medicine of the skin infection that causes because of antibacterial, viral infection at preparation treatment skin.
10. the purposes of a mixture, described mixture is by the Radix Polygoni Ciliinerve of 30-99 parts by weight, the Rhizoma Polygoni Paleachi of 3-15 parts by weight, the Rhizoma Polygoni Cuspidati of 5-20 parts by weight, the Borneolum Syntheticum of 3-15 parts by weight constitutes or by the Radix Polygoni Ciliinerve of 30-99 parts by weight, the Rhizoma Polygoni Paleachi of 3-15 parts by weight, the Rhizoma Polygoni Cuspidati of 5-20 parts by weight, the Borneolum Syntheticum of 3-15 parts by weight, the Radix Salviae Miltiorrhizae of 3-15 parts by weight, the Cortex Moutan of 3-15 parts by weight, the Sanguis Draxonis of 3-15 parts by weight, the Corium elephatis of processing of 1-8 parts by weight constitutes, it is characterized in that described mixture is used for preparation treatment skin and scalds burn, wound is or/and because of antibacterial, viral infection and the medicine of the skin infection that causes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100300651A CN100441206C (en) | 2005-09-28 | 2005-09-28 | Compound medicine for treating skin scald, insult and sore and its preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100300651A CN100441206C (en) | 2005-09-28 | 2005-09-28 | Compound medicine for treating skin scald, insult and sore and its preparation |
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| CN1939426A true CN1939426A (en) | 2007-04-04 |
| CN100441206C CN100441206C (en) | 2008-12-10 |
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| CNB2005100300651A Active CN100441206C (en) | 2005-09-28 | 2005-09-28 | Compound medicine for treating skin scald, insult and sore and its preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105031255A (en) * | 2015-07-12 | 2015-11-11 | 姚静 | Traditional Chinese medicine preparation for abdominal trauma nursing and its preparation method |
| CN105920254A (en) * | 2016-06-27 | 2016-09-07 | 王青年 | Hypertrophic scar eliminating reducing liquid |
| CN107095912A (en) * | 2017-06-20 | 2017-08-29 | 遵义医学院 | A kind of Ultramicro-powder ointment of Repercusion analgesia and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1087948C (en) * | 1999-07-26 | 2002-07-24 | 吴永春 | Fast-acting burn and scald treating liquid |
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2005
- 2005-09-28 CN CNB2005100300651A patent/CN100441206C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105031255A (en) * | 2015-07-12 | 2015-11-11 | 姚静 | Traditional Chinese medicine preparation for abdominal trauma nursing and its preparation method |
| CN105920254A (en) * | 2016-06-27 | 2016-09-07 | 王青年 | Hypertrophic scar eliminating reducing liquid |
| CN107095912A (en) * | 2017-06-20 | 2017-08-29 | 遵义医学院 | A kind of Ultramicro-powder ointment of Repercusion analgesia and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100441206C (en) | 2008-12-10 |
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