CN106729631A - Treat the externally applied spray of intractable skin ulcer - Google Patents

Treat the externally applied spray of intractable skin ulcer Download PDF

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Publication number
CN106729631A
CN106729631A CN201710160487.3A CN201710160487A CN106729631A CN 106729631 A CN106729631 A CN 106729631A CN 201710160487 A CN201710160487 A CN 201710160487A CN 106729631 A CN106729631 A CN 106729631A
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windproof
basic fibroblast
growth factor
pulvis
externally applied
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王琳
张建伟
陈小永
崔应麟
厉菁
陈辉
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Henan University of Traditional Chinese Medicine HUTCM
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Henan University of Traditional Chinese Medicine HUTCM
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Abstract

It is that, by the root of kudzu vine, kuh-seng, golden cypress, Golden Larch Bark, oldenlandia diffusa, Chinese gall is windproof the invention discloses a kind of externally applied spray for treating intractable skin ulcer, borneol and recombination human basic fibroblast growth factor pulvis are formulated:Add 95% ethanol percolation after bulk drug is crushed first, be made Chinese medicine extract, be subsequently adding the mixing of recombination human basic fibroblast growth factor pulvis;Take after 75% ethanol of menthol dissolves as flavouring, and add mixing after Tween 80 solubilising, obtain finished product spray.The advanced current Good preparation technology of present invention application, science with the addition of new composition on the basis of traditional Chinese medicine compound preparation active principle is retained, change the traditional consumption proportion of active compound, coordinate the oldenlandia diffusa of addition, Chinese gall, windproof etc., it is enhanced the response to treatment of medicine antibacterial, analgesia and heat-clearing and damp-drying drug, while with the addition of western medicine composition, the externally applied spray being made uses more convenient, rapid-action, drug effect is more longlasting.

Description

Treat the externally applied spray of intractable skin ulcer
Technical field
Medicine the present invention relates to treat skin ulcer, more particularly, to a kind of external spray for treating intractable skin ulcer Agent.
Background technology
For chronic ulcer of skin, the traditional Chinese medical science think perverse trend it is flourishing be external cause, positive unsaturated vapor be internal cause, prolonged illness is weakened body resistance, qi and blood The stasis of blood is stagnant, seeks Wei Buchang, failure of skin and muscle to be nourished;Should be got rid of evils with righting during treatment, clearing heat and detoxicating, nourishing qi and blood, putrefaction-removing granulation-promoting be as principle.And Doctor trained in Western medicine theory thinks that intractable skin ulcer is Skin preparation, a kind of body surface disease of liquefaction infection and necrosis, is burst with skin It is Clinical symptoms that ulcer can not heal for a long time.Because sore face is difficult to heal and consume very big, very big pain is caused to patient, seriously Influence the healthy and quality of life of patient.Treatment method common at present has local physiotherapy, external used medicine and operative treatment. Relative to other treatment methods, external medication is clinically using wider.
Chinese patent drug " sore spirit " is motherland's traditional Chinese medicine compound preparation, comes from ancient clinical proved recipe, is by the equivalent root of kudzu vine, hardship Ginseng, golden cypress, Golden Larch Bark and a small amount of pearl, borneol and zinc oxide are extracted and formed, and succession has centuries history so far, has obtained ground Square authentication code is commercially produced and sold.Plurality of Chinese composition is included in the medicine, these Chinese medicines are refined into extraction system during preparation External application after into powder or paste, by percutaneous drug delivery, with anti-inflammatory analgetic, promoting blood circulation and removing blood stasis, putrefaction-removing granulation-promoting effect, preparation used In it is in the majority with powder.When sore medicinal powder is administered, by its operation instruction, should in sore face upper berth and the thick drug delivery layers of about 1 mm, But in actual mechanical process, it is difficult to meet the requirement in explanation:Because medicinal powder is fine and closely woven, smooth, easily dispersion, medicine exists when spreading pesticides Distribution on sore face is difficult to reach uniformly, causes medicinal powder on local sore face to adhere to thicker, then absorbs excessive diffusate influence and heals Merging causes drug waste, and on the sore face of part attachment medicinal powder is less can not reach drug concentration, the skin at particularly sagging position Skin ulcer, medicinal powder is easier to come off, it is difficult to reaches and persistently plays curative effect, causes medicine to be reached in damage location effectively dense Degree;And another formulation-ointment of sore spirit, during smearing, drug contact infected wound easily triggers bacterial wound contamination to arrive On ointment, superinfection is caused, influence using again for ointment.Not only exist in formulation because commercially available sore is clever certain Drawback, while in Clinical practice, applicant further found that the herbal mixture is gentleer due to the property of medicine, for skin ulcer area compared with Greatly, the sore face of refractory conjunction long, its therapeutic effect is unsatisfactory.
The content of the invention
It is an object of the invention to provide a kind of externally applied spray for treating intractable skin ulcer, the spray is easy to use, Therapeutic effect is protruded, it is adaptable to the healing of human body skin ulcer, bedsore, wound, pernio, burn and postoperative wound, especially suitable The recovery of intractable skin ulcer caused by because of reasons such as malnutrition, the long, liquefaction of fat of otch.
To achieve the above object, the present invention can take following technical proposals:
It is of the present invention treatment intractable skin ulcer externally applied spray, be by the bulk drug root of kudzu vine, kuh-seng, golden cypress, Golden Larch Bark, Oldenlandia diffusa, Chinese gall, windproof, borneol and recombination human basic fibroblast growth factor press following weights and side Method is prepared from:
Proportioning:
20~50g of the root of kudzu vine, 15~40g of kuh-seng, golden cypress 30~60 g, 40~80g of Golden Larch Bark, oldenlandia diffusa 40~80g, five times Son 20~50g, windproof 20~50g, borneol 10~30g and 0.63MIU recombination human basic fibroblast growth factor pulvis 1 ~ 3 Branch;
Specific preparation method is as follows:
Add 95% ethanol percolation after bulk drug is crushed, be made Chinese medicine extract 400ml, be subsequently adding recombination human basic fibroblast Porcine HGF pulvis is mixed;Take after 75% ethanol of 30g menthols dissolves as flavouring, and add Tween-80 solubilising extremely It is well mixed after 500ml, obtains finished product spray.
To reach best therapeutic effect, each bulk drug can be prepared according to following weight portion:Root of kudzu vine 50g, kuh-seng 40g, golden cypress 60 g, Golden Larch Bark 80g, oldenlandia diffusa 80g, Chinese gall 50g, windproof 50g, borneol 30g and 0.63MIU recombined human 1, basic fibroblast growth factor pulvis.
Also can be prepared by following weight parts:Root of kudzu vine 20g, kuh-seng 15g, golden cypress 30g, Golden Larch Bark 60g, oldenlandia diffusa 60g, Chinese gall 20g, windproof 35g, 3, borneol 20g and 0.63MIU recombination human basic fibroblast growth factor pulvis.
Also can be prepared according to following weight parts:Root of kudzu vine 30g, kuh-seng 30g, golden cypress 40g, Golden Larch Bark 40g, oldenlandia Careless 40g, Chinese gall 30g, windproof 20g, 2, borneol 10g and 0.63MIU recombination human basic fibroblast growth factor pulvis.
When the present invention is for industrialized production, can increase according to aforementioned proportion and expand.
Finished product spray is divided in the vial with sprayer unit, when using, liquid is sprayed on skin by direct topical administration Skin surface.
The advantage of the invention is that using advanced current Good preparation technology, retaining traditional Chinese medicine compound preparation active principle On the basis of science with the addition of new composition, and change the traditional consumption proportion of bulk drug, coordinate the oldenlandia of addition It is grass, Chinese gall, windproof, be enhanced the response to treatment of medicine antibacterial, analgesia and heat-clearing and damp-drying drug, while with the addition of Western medicine into Part, promotion mucocutaneous reparation and healing, and the formulation of combination drug is changed, the externally applied spray being made is used and is more convenient, Liquid can directly be sprayed onto the mucous membrane or diseased region of the skin that festers, and rapid-action, drug effect is more longlasting.
Recombination human basic fibroblast growth factor (Recombinant Human Basic Fibroblast Growth Factor, rh-bFGF) it is first class national new drug, from the Escherichia coli of genetic engineering restructuring, it is into fiber finer The efficient growth accelerator of born of the same parents, vascular endothelial cell and VSMC, it can strongly facilitate the shape of new capillary vessel Into, granulation tissue capillary quantity and blood flow are dramatically increased, accelerate the recovery of injury tissue function.The invention Added in pure Chinese medicinal preparation, traditional Chinese medicine is organically combined with Western medicine, form the compound combination in Chinese and Western Medicine, the principle for promoting is increased using herbal treatment, Western medicine, spray is had more preferable therapeutic effect.
Spray of the present invention is so that clearing heat and detoxicating, cool blood row is stagnant, Eradicates necrotic tissue and promoting muscle growings as the rules for the treatment of, Chinese and Western medicine is carried out the compatibility group of science Side, to reach the purpose treated both principal and secondary aspect of disease.The pharmacology of the raw materials used medicine of the present invention is as follows:The root of kudzu vine:It is sweet, pungent, it is cool in nature, return lung, Stomach, brings down a fever with expelling pathogenic factors from muscles and skin, the effect of promoting eruption is promoted the production of body fluid;Kuh-seng:Bitter, cold in nature, Return liver, kidney, large intestine, small intestine, bladder, the heart channel of Hang-Shaoyin, The effect of with heat-clearing and damp-drying drug, cure mainly pruitus, wet poison sore;Golden Larch Bark:Property pungent, temperature, return lung, the spleen channel be antibacterial, antipruritic, Treatment of ulcer pyogenic infections, eczema wet sore;Oldenlandia diffusa:The sweet, bitter cold of property, enters stomach, large intestine, small intestinl channel, with clearing heat and detoxicating, antibacterial Effect of anti-inflammatory;It is windproof:Taste is pungent, sweet, slightly warm in nature, return bladder, lung, spleen, Liver Channel, expel pathogenic wind from the body surface, and win effect of wet analgesic, use In rubella itch, arthralgia pain due to rheumatism;
In medicine components used of the invention, with the root of kudzu vine, kuh-seng, golden cypress as monarch drug in a prescription, Golden Larch Bark, Chinese gall are ministerial drug, oldenlandia Grass is adjutant, windproof to make medicine, and human alkaline fibroblast growth factor promotes wound reparation, healing as adjuvant drug.
Obtained externally applied spray of the invention can directly to affected part medication, and the effect with anti-inflammation, heat-clearing and damp-drying drug can promote Enter superficial cutaneous capillaries and fibroblastic regeneration, then strengthen the formation of skin granulation tissue, and skin can be effectively improved Local blood circulation, improves the permeability of blood supply and local cells, and curative effect is obvious, few side effects;And can be made using spray Medicaments uniformity is scattered in affected part, and skin is easy to absorb, is combined, and preferably plays reciprocation.With conventional use of powder and cream Agent is compared, with easy to use, medicine spray it is uniform, can accurate quantitative analysis, drug effect is rapid, be easy to absorb and safe and efficient etc. excellent Point, skin ulcer treatment effect especially larger to sore face, sagging position is even more ideal, at the same solve drug dose it is uneven, Medicinal powder is difficult to adhere to and the problems such as ointment bacteria contamination, is not required to be sterilized with disinfectants such as the tincture of iodine, alcohol around sore face, is that treatment is moved Prolong do not heal, the external used medicine that the prolonged mucocutaneous ulcer do not controlled is ideal.
The Multiple components such as root of kudzu vine isoflavone-containing, xyloside in spray of the present invention, can expelling pathogenic factors from muscles and skin bring down a fever, promoting eruption of promoting the production of body fluid;It is bitter Ginseng is containing various alkaloids, the effect with heat-clearing and damp-drying drug, antibiotic skin-care such as Sophoridine, Chinese scholartree lush alcohol, anagyrine, matrines;Golden cypress Its active ingredient be phellodendrine, with suppress bacterium and fungi growth effect, infiltrative type is oozed out based on inflammatory lesions have Good effect, is clinically usually used in the treatment of sore swollen toxin;Contained native chaste tree formic acid, native chaste tree acetic acid and native chaste tree propionic acid in Golden Larch Bark The generation of the fungies such as sporidiole bacteria, Candida albicans can be suppressed, can be denatured tinea bacterium eucaryotic cell structure, lose its cell membrane shrinkage Physiological function is lost, antibacterial, antipruritic effect is played;The fruit of Chinese magnoliavine contains Gallotannin, the work with convergence, bacteria growing inhibiting With, can solidify the local tissue protein such as skin, mucous membrane, ulcer, one layer of envelope is formed, blood clotting can be accelerated, play Anastalsis, can make skin, mucosa ulcer face histone solidify, while also collapsible thin vessels and stop blooding;Borneol has Antibacterial, antiviral, anti-inflammatory and antalgic, pharmaceutical research point out the bioavilability that it can improve other drugs;Rh-bFGF is to wound The relevant cell of healing has regulation chemotaxis, can induced fibroblast, vascular endothelial cell, VSMC Growth, improves microcirculation, while stimulating the albumen synthesis of fibroblast and extracellular matrix, accelerates the healing of the surface of a wound, in wound Mouth is repaired and healing aspect has preferable mediation.
There is externally applied spray prepared by the present invention antibacterial, antivirus to act on, and can promote the rehabilitation of otch, bedsore and eczema, treat Effect substantially, few side effects, it is adaptable to various acute and chronic ulcers, bedsore, wound, pernio, burn and scald, burn(Shallow II degree, depth II Degree, granulation wound)And the healing of postoperative wound, for because of malnutrition, scar diathesis, postoperative wound poor healing, fat liquor The recovery of intractable skin ulcer has prominent therapeutic effect caused by the reasons such as change.
Specific embodiment
More detailed description is done to the present invention below by instantiation.In the following embodiments, each bulk drug is with g Benchmark is measured.In preparation of industrialization, the weight portion benchmark of each bulk drug can in proportion increase expansion.
Embodiment 1
It is of the present invention treatment intractable skin ulcer externally applied spray, be by the bulk drug root of kudzu vine, kuh-seng, golden cypress, Golden Larch Bark, Oldenlandia diffusa, Chinese gall, windproof, borneol and recombination human basic fibroblast growth factor press following weights and side Method is prepared from:
Proportioning:
Root of kudzu vine 50g, kuh-seng 40g, golden cypress 60 g, Golden Larch Bark 80g, oldenlandia diffusa 80g, Chinese gall 50g, windproof 50g, borneol 1,30g and 0.63MIU recombination human basic fibroblast growth factors pulvis;
Specific preparation method is as follows:
1)First by the root of kudzu vine, kuh-seng, golden cypress, Golden Larch Bark, oldenlandia diffusa, Chinese gall, windproof seven tastes Chinese medicine in forced air drying 60 DEG C of drying in case;
2)Enter after pulverizer is ground into powder and be placed in wide-mouth bottle, add 10 times of 95% medical ethanols of amount to soak 4 hours, Ran Houjia Circumfluence distillation 1 hour, medical filtration is separately deposited;
3)The dregs of a decoction add 5 times of 95% medical ethanols of amount again, with method immersion, heating and refluxing extraction, filtering;
4)Gained liquid will merge twice, heating concentration, after vacuum distillation, be obtained 400ml concentrates be put into it is standby in test tube;
5)Borneol is put into appropriate 95% medical ethanol and grinds molten rear addition the 4th)Step is contained in the test tube of gained concentrate;
6)By 0.63MIU recombination human basic fibroblast growth factor pulvis(Trade name bFGF-ESSEX)It is put into appropriate 95% medical Ground in ethanol it is molten after also add the 4th)Step is contained in the test tube of gained concentrate;
7)With menthol as flavouring, with Tween-80 as solubilizer:Test tube is added after 10g menthols are dissolved with 75% ethanol In, Tween-80 is then added, the liquid in test tube is reached 500ml;
8)Liquid is divided into 4 parts, sealing preserve in the vial with sprayer unit is respectively charged into.
Embodiment 2
It is of the present invention treatment intractable skin ulcer externally applied spray, be by the bulk drug root of kudzu vine, kuh-seng, golden cypress, Golden Larch Bark, Oldenlandia diffusa, Chinese gall, windproof, borneol and recombination human basic fibroblast growth factor press following weights and side Method is prepared from:
Proportioning:Root of kudzu vine 20g, kuh-seng 15g, golden cypress 30g, Golden Larch Bark 60g, oldenlandia diffusa 60g, Chinese gall 20g, windproof 35g, ice 3, piece 20g and 0.63MIU recombination human basic fibroblast growth factor pulvis.
Specific preparation method is with embodiment 1.
Embodiment 3
It is of the present invention treatment intractable skin ulcer externally applied spray, be by the bulk drug root of kudzu vine, kuh-seng, golden cypress, Golden Larch Bark, Oldenlandia diffusa, Chinese gall, windproof, borneol and recombination human basic fibroblast growth factor press following weights and side Method is prepared from:
Proportioning:Root of kudzu vine 30g, kuh-seng 30g, golden cypress 40g, Golden Larch Bark 40g, oldenlandia diffusa 40g, Chinese gall 30g, windproof 20g, ice 2, piece 10g and 0.63MIU recombination human basic fibroblast growth factor pulvis;
Specific preparation method is with embodiment 1.
Embodiment 4
Externally applied spray prepared by the embodiment of the present invention 1 ~ 3 is carried out into clinical effectiveness checking:
1st, the patient of selection bedsore, wound, pernio, burn and postoperative wound delayed union, 6 ~ 20 square centimeters of ulcer area, Sore face not healed and include research object more than more than 15 days persons, and 79 are selected in altogether, signature Informed Consent Form before being selected in.
2nd, selected patient is randomly divided into 3 groups, each group no difference of science of statistics in age, sex(p>0.05), each group people Number is respectively 24,28 and 27.First group of aerosol spray that embodiment 1 to embodiment 3 Dui Ying not be taken to third component. Twice a day, sprayed 1-3 times according to sore face size every time, about 3ml, be within 7 days a course for the treatment of.
3rd, curative effect determinate standard
Recovery from illness:Ulcer surface heals completely, more than first quarter moon without recurrence.
Take a turn for the better:Ulcer surface area reduces 50% before relatively treating, and oozes out reduction, and part is formed a scab.
It is invalid:The state of an illness is without improvement.
4th, result statistics
After including the patient for the treatment of and carrying out two treatments of the course for the treatment of,
In first group of 24 patients, fully recover 13 people, accounts for 54.17%;Take a turn for the better 9 people, accounts for 37.50%;Invalid 2 people, accounts for 8.33%, Total effective rate is 91.67%.
In second group of 28 patients, fully recover 12 people, accounts for 42.86%;Take a turn for the better 11 people, accounts for 39.29%;Invalid 5 people, accounts for 17.86%.Total effective rate is 82.14%.
In 3rd group of 27 patients, fully recover 17 people, accounts for 62.96%;Take a turn for the better 7 people, accounts for 25.93%;Invalid 3 people, accounts for 11.11%.Total effective rate is 88.89%.
5th, typical case
(1) poplar, 81 years old, retired worker, man in more than 30 years of patient's diabetes B, applied Novolin 30R insulin over nearly 10 years Pin controls blood sugar, and because patient's " cerebral infarction " is long-term confined to bed, " bedsore " occurs in buttocks before 1 year, through medicines such as external applications " erythromycin " Afterwards, effect is poor.Take embodiment 1 spray treat the 1st course for the treatment of after, sore face is substantially cut down, and phenomenon of suppurating does not occur.Take After 2 courses for the treatment of, sore face is oozed out and is disappeared completely, gradually forms a scab.Paid a return visit after half a year, without recurrence.
(2) Zhang is bright, 57 years old, female, company clerk, because of " uremia " row kidney transfer operation, postoperative wound disunion 20 days, Liquefaction of fat is locally lain in, after the 1st course for the treatment of of spray of Application Example 2, liquefaction of fat is obviously improved, local red and swollen regression. After taking the 2nd course for the treatment of, skin incrustation.Hereafter do not recur.
(3) Sun's English, 62 years old, man, peasant, suffer from " diabetes " 3 months, right sufficient halluces festers, walking pain unbearably, After the spray of Application Example 3 treats the 2nd course for the treatment of, sore face reduces earlier above, after consolidating the 3rd course for the treatment of of application, the healing of sore face, after Do not recur again.
Active ingredient, preparation technology, quality standard, primary stability and pharmacodynamics are carried out by externally applied spray of the present invention Deng research, it was demonstrated that the externally applied spray for because caused by the reasons such as malnutrition, the long, liquefaction of fat of otch recalcitrant dermal it is routed The recovery of ulcer has substantially and the treatment advantage of uniqueness;Compared with traditional sore medicinal powder or ointment, external application prepared by the present invention Spray administration is accurate, quantitative, easy to use, and its curative effect is substantially, persistent, toxic and side effect be small, materials are cheap, without skin irritatin Property, there is vast potential for future development.

Claims (4)

1. a kind of externally applied spray for treating intractable skin ulcer, it is characterised in that:It is by the bulk drug root of kudzu vine, kuh-seng, golden cypress, soil Chaste tree skin, oldenlandia diffusa, Chinese gall, windproof, borneol and recombination human basic fibroblast growth factor are matched somebody with somebody by following weight parts Than being prepared from method:
Proportioning:
20~50g of the root of kudzu vine, 15~40g of kuh-seng, golden cypress 30~60 g, 40~80g of Golden Larch Bark, oldenlandia diffusa 40~80g, five times Son 20~50g, windproof 20~50g, borneol 10~30g and 0.63MIU recombination human basic fibroblast growth factor pulvis 1 ~ 3 Branch;
Specific preparation method is as follows:
Add 95% ethanol percolation after bulk drug is crushed, be made Chinese medicine extract 400ml, be subsequently adding recombination human basic fibroblast Porcine HGF pulvis is mixed;Take after 75% ethanol of 30g menthols dissolves as flavouring, and add Tween-80 solubilising extremely It is well mixed after 500ml, obtains finished product spray.
2. it is according to claim 1 treatment intractable skin ulcer externally applied spray, it is characterised in that:The bulk drug Weight is:Root of kudzu vine 50g, kuh-seng 40g, golden cypress 60 g, Golden Larch Bark 80g, oldenlandia diffusa 80g, Chinese gall 50g are windproof 50g, 1, borneol 30g and 0.63MIU recombination human basic fibroblast growth factor pulvis.
3. it is according to claim 1 treatment intractable skin ulcer externally applied spray, it is characterised in that:The bulk drug Weight is:Root of kudzu vine 20g, kuh-seng 15g, golden cypress 30g, Golden Larch Bark 60g, oldenlandia diffusa 60g, Chinese gall 20g are windproof 35g, 3, borneol 20g and 0.63MIU recombination human basic fibroblast growth factor pulvis.
4. it is according to claim 1 treatment intractable skin ulcer externally applied spray, it is characterised in that:The bulk drug Weight is:Root of kudzu vine 30g, kuh-seng 30g, golden cypress 40g, Golden Larch Bark 40g, oldenlandia diffusa 40g, Chinese gall 30g are windproof 20g, 2, borneol 10g and 0.63MIU recombination human basic fibroblast growth factor pulvis.
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Application publication date: 20170531