CN104435730A

CN104435730A - Externally applied traditional Chinese medicine ointment for treating skin ulcer

Info

Publication number: CN104435730A
Application number: CN201410664672.2A
Authority: CN
Inventors: 向小明
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-11-20
Filing date: 2014-11-20
Publication date: 2015-03-25
Anticipated expiration: 2034-11-20
Also published as: CN104435730B

Abstract

The invention discloses an externally applied traditional Chinese medicine ointment for treating skin ulcer. The ointment is prepared from astragalus membranaceus, angelica sinensis, cortex phellodendri, scutellaria baicalensis, rheum officinale, shinyleaf pricklyash root, rhizoma paridis, cape jasmine, bletilla striata, ramie root, elephant hide, selaginella tamariscina, borneol, beewax, rapeseed oil, stearic acid, glycerinum, glycerin monostearate, cetanol, potassium hydroxide, ethylparaben and distilled water. The invention further provides a method for preparing the novel ointment for treating skin ulcer. The ointment has the effects of clearing heat, removing toxicity, removing necrotic tissue, promoting granulation, eliminating stasis to subdue swelling, promoting blood circulation, astringing, nourishing skin, relieving pain, reducing wound exudation, quickly repairing wound, relieving scar growth and the like, has the advantages of reasonable formula, simple preparation, proper price and remarkable curative effect, and is convenient to apply.

Description

A kind of external application Chinese medicine ointment for the treatment of sores ulceration of skin

Technical field

The invention belongs to technical field of Chinese medicines, particularly relate to a kind of external application Chinese medicine ointment for the treatment of sores ulceration of skin.

Background technology

Motherland's medical science calls infections section burn skin infection, external injury and the evil infective agent of poison are the principal elements causing creating infections, as: chemical substance, electrical equipment, high light, firearm, bullet, the blasts etc. such as flame, boiling water, steam, molten steel and acid, alkali, phosphorus, phenol all can cause skin injury.The skin hypersensitivity damage that insect and animal biting, cold injury, dermatitis rhus, various animals and plants toxin, lonizing radiation, medicine and a variety of causes cause also belongs to this category.According to the neodoxy of professor Xu Rongxiang to burn theory, this subject can be summarized and be divided into following a few class: 1. hot injury's class, comprises burn and scald, chemical burn, electric burn, electric burn; 2. wound class, as the damage of skin ulceration, knife injury; 3. to burst sick class, comprise the infection of burn and scald and wound and wound surface and burst sick, the infection that dermatosis causes and ulcer, and the traumatic infection caused by inside and outside, woman, youngster, face Deng Ge section disease and ulcer.

The burns unit treatment technology that motherland's medical science is carried out is except the moistening burn exposure method of the auspicious MEIBAO of Xu Rong, great majority mainly allow burn wound keep dry, prevent bacterial invasion from infecting, its deep burn wound electricity consumption baking, makes the rear implementation of local necrosis tissue drying incrustation cut crust and skin grafting is treated.Western medicine is also in surgery's treatment stage of stagnation to burn, wound and ulcer treatment.Therefore, to lose some benefits from modern medicine to make burn patient and cut crust, the medical expenses of the misery that the operations such as skin-grafting bring and great number, invention one has that reducing swelling and alleviating pain is fast, short treating period, wound healing fast, no pain of changing dressings, either shallow do not stay scar, the degree of depth such as not to be made skin graft at the Chinese medicine preparation of magical curative effect, significant.

Summary of the invention

Object of the present invention is exactly for above-mentioned treatment Problems existing, a kind of heat-clearing and toxic substances removing, removing the necrotic tissue and promoting granulation, dissipating blood stasis for subsidence of swelling, putrefaction removing and tissue regeneration promoting are provided, convergence of invigorating blood circulation, skin moistening pain relieving, reduce wound surface ooze out, rapid wound repairing, the external application Chinese medicine ointment of the effects such as lessen scar formation growth, be adapted to the treatment of various burn, wound, skin ulcer, this medicine makes simple, moderate, evident in efficacy, application is convenient.

This ointment is that inventor adopts surgery of Chinese medicine skin infection theoretical basis, the handed down from the older generations of the family and modern burn medical technologies marrow in conjunction with the successive dynasties, the accumulation through being devoted for years to for many years in the academic thought of Ulcerated Burn Wounds Treated treatment and clinical research and unique therapy of drawing.In side, Radix Et Rhizoma Rhei, Radix Scutellariae, Rhizoma Paridis, Fructus Gardeniae, Cortex Phellodendri, Radix Zanthoxyli, Herba Selaginellae have heat-clearing and toxic substances removing, and detumescence is invigorated blood circulation, effect of analgesic and scar eliminating.According to modern pharmacological research and my clinical observation for many years, find that above medicine has stronger anti Bacillus pyocyaneu Flugge, staphylococcus aureus, pyococcus, multiple Gram-negative to local challenge pyemia infection of burning, positive bacteria has obviously suppression to kill and the preventive and therapeutic effect such as stronger removing toxic substances infection and the growth of prevention lessen scar formation; In side, the Radix Astragali, Radix Angelicae Sinensis, the Pseudobulbus Bletillae (Rhizoma Bletillae), Corium elephatis, Borneolum Syntheticum, Cera Flava, Oleum Brassicae campestris have the effect that the ulcer such as benefiting qi and nourishing blood, skin moistening putrefaction removing, expelling pus and promoting granulation pain relieving do not close up for a long time altogether; The present invention is a kind of ointment, and it can be protected skin wound, regulate transepidermal water unlikely drying, thus in this ointment with traditional Chinese herb medicine compatibility; can make that wound surface is changed dressings, medicine carrying non-greasy, skin of cannot not changing dressings stickyly, sticky clothing; change dressings without pain, few hemorrhage, without advantages such as remaining medicine crusts.

The present invention is made up by weight ratio of following traditional Chinese medicines: Radix Astragali 450-550g, Radix Angelicae Sinensis 400-600g, Cortex Phellodendri 400-600g, Radix Scutellariae 450-550g, Radix Et Rhizoma Rhei 450-550g, Radix Zanthoxyli 350-550g, Rhizoma Paridis 400-600g, Fructus Gardeniae 480-600g, Pseudobulbus Bletillae (Rhizoma Bletillae) 450-600g, Radix Boehmeriae 450-550g, Corium elephatis 100-300g, Herba Selaginellae 400-600g, Borneolum Syntheticum 25-30g, Cera Flava 250-400g, Oleum Brassicae campestris 2000-3000g, stearic acid 450-550g, glycerol 450-550g, glyceryl monostearate 50-100g, hexadecanol 100-200g, potassium hydroxide 45-55g, ethyl hydroxybenzoate 20-30g, distilled water 3700-3800g.

Optimum weight proportion: Radix Astragali 500g, Radix Angelicae Sinensis 500g, Cortex Phellodendri 500g, Radix Scutellariae 500g, Radix Et Rhizoma Rhei 500g, Radix Zanthoxyli 500g, Rhizoma Paridis 500g, Fructus Gardeniae 500g, Pseudobulbus Bletillae (Rhizoma Bletillae) 500g, Radix Boehmeriae 500g, Corium elephatis 200g, Herba Selaginellae 500g, Borneolum Syntheticum 20g, Cera Flava 350g, Oleum Brassicae campestris 2500g, stearic acid 500g, glycerol 500g, glyceryl monostearate 75g, hexadecanol 150g, potassium hydroxide 50g, ethyl hydroxybenzoate 25g, distilled water 3750g.

Detailed description of the invention is as follows:

(1) take each weight portion: Radix Astragali 500g, Radix Angelicae Sinensis 500g, Cortex Phellodendri 500g, Radix Scutellariae 500g, Radix Et Rhizoma Rhei 500g, Radix Zanthoxyli 500g, Rhizoma Paridis 500g, Fructus Gardeniae 500g, Pseudobulbus Bletillae (Rhizoma Bletillae) 500g, Radix Boehmeriae 500g, Corium elephatis 200g, Herba Selaginellae 500g, Borneolum Syntheticum 20g, Cera Flava 350g, Oleum Brassicae campestris 2500g, stearic acid 500g, glycerol 500g, glyceryl monostearate 75g, hexadecanol 150g, potassium hydroxide 50g, ethyl hydroxybenzoate 25g, distilled water 3750g.

(2) above-mentioned stearic acid, glycerol, glyceryl monostearate, hexadecanol is got in beaker, heating in water bath to 90 DEG C makes material melting, is uniformly dissolved as oil phase, then potassium hydroxide, ethyl hydroxybenzoate being added in distilled water water dissolves as aqueous phase, under stirring at 90 DEG C, aqueous phase is slowly added oil phase, high-speed stirred carries out emulsion reaction 20min, and being cooled to room temperature, to obtain emulsifying agent for subsequent use.

(3) get the above-mentioned Radix Astragali, Radix Angelicae Sinensis, Cortex Phellodendri, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Zanthoxyli, Rhizoma Paridis, Fructus Gardeniae, the Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Boehmeriae, Corium elephatis, Herba Selaginellae clear water soak, after decoction, enter Oleum Brassicae campestris, then torture to the dried-up Huang of medicine with slow fire and float filtration of removing slag.

(4) concentrated medicament of filtration and Borneolum Syntheticum, Cera Flava and emulsifying agent obtained above are dissolved and move back to foam clean from fire, form semi-solid mixed type ointment after condensation, basin bottling is for subsequent use.

All medicines are prepared into ointment above, have heat-clearing and toxic substances removing, removing the necrotic tissue and promoting granulation, dissipating blood stasis for subsidence of swelling, putrefaction removing and tissue regeneration promoting, convergence of invigorating blood circulation, skin moistening pain relieving, reduce wound surface ooze out, rapid wound repairing, the effects such as lessen scar formation growth.

The present invention has the following advantages:

(1) the present invention is pure Chinese medicinal preparation, and each component meets the regulation of Pharmacopoeia of People's Republic of China, little to human body toxic and side effects, reliably comparatively safe.

(2) toxin that the present invention can make burn slough degenerate separation and alluvial is drained, and newborn cell tissue can be made to grow fast and accelerate wound healing, shorten treatment time.

(3) the present invention makes wound surface blood transport by drug effect and circulation improves, and makes to ooze out minimizing, and can effectively suppress, kill bacteria makes inflammation prompt resolution.

(4) the present invention is adapted to the treatment of various burn, wound, skin ulcer, makes simple, moderate, evident in efficacy, the features such as application is convenient.

Below by way of clinical observation experiment, set forth beneficial effect of the present invention further

1, patient profiles

The chronic ulcer of skin patient that my Out-patient Department is medical, MethodsThe cases enrolled 140 example, male 74 example, women 66 example, injured reason: wound 28 example, burn 35 example, furuncle, abscess ulceration 26 example, diabetic gangrene 33 example, varicose veins of the lower extremity 8 example, ulcer 10 example caused by hemangioma injection treatment.

2, patient selection's standard

1. meet 140 routine chronic ulcer of skin patients of MethodsThe cases enrolled condition, the course of disease is more than 3 weeks.2. patient temperature is normal, hemogram in normal range, stable disease, and the medication of same disease whole body therapeutic is identical.3. agree to through sufferers themselves and can adhere to continuing dressing change at the court's dressing room.

3, Therapeutic Method

140 routine patients are divided into treatment group and each 70 examples of matched group at random, and the age of two groups of patients, injured reason, ulcer level, area and time there was no significant difference, have comparability.Treatment group patient is first with 0.9% sodium chloride solution cleaning or iodophor disinfection wound surface, and its absorbed themselves treated by vesicle, and large blister oozes out the capable low level of after date at blister to be cut off tapping and retains bubble skin.Patients with deep burn should remove beancurd sheet and slough as early as possible in the tissue rotten de-liquefaction phase.Do not need anesthesia in debridement process, strictly follow noinvasive cleaning principle, then faster for skin infection of the present invention cream spatula is applied to wound surface and adopts and to expose or gauze such as to be applied ointment or plaster at the occlusive dressing, change dressings every day once, until wound healing.Matched group only changes faster for the skin infection being applied to ulcer wound surface cream into moist expose burn ointment, and all the other are identical with treatment group.

4, curative effect judging standard

Treatment group and matched group all do Statistical Comparison evaluation after dressing change 30d.Total obvious effective rate is that healing adds effective percentage.

Cure: symptom, sign all disappear, functional activity recovers normal, wound healing.

Effective: symptom, sign are clearly better, and wound surface obviously reduces, yellowish pink turn red, and pus tails off.

Invalid: skin surface symptom without improvement, or have increase the weight of tendency.

5, therapeutic outcome

In the routine sores ulceration of skin patient for the treatment of group 70, cure 59 examples, cure rate 84.28%, effective 7 examples, total obvious effective rate 94.29%, invalid 4 examples, inefficiency 5.71%.In the routine sores ulceration of skin patient of matched group group 70, cure 36 examples, cure rate 51.43%, effective 16 examples, total obvious effective rate 72.29%, invalid 18 examples, inefficiency 25.71%.

Above clinical practice proves that this ointment is in burn wound's treatment, intuitively can understand wound surface clinical healing process, can effectively by drug osmotic subcutaneous tissue; Dirt, the bacteriotoxin that can effectively purify between wound surface and tissue comes off with being separated of slough; Effectively can improve local circulation, stop the stagnant impaired local organization necrosis progrediens of the stasis of blood, infection control, make the normal structure invasion and attack of burn slough not under wound surface; And effectively can promote the Regeneration and Repair of wound surface damaged tissues.In the de-liquefaction eliminating of deep wounds slough corruption and growth course; because this ointment effect is unique; when the most flesh level flesh shoot regeneration of wound tissue corruption; granulation surface can form one deck white or faint yellow gluey protecting film, and this tunic is the feature proving that burn wound's skin physiology regeneration and tissue growth are repaired.To dark two degree, 3-degree wound can remove rapidly separation slough.As dark two degree of wound surface 4 ~ 5 days downright bad layers start the liquefaction that comes off, within about 10 days, liquefaction is made to be in peak, within about 15 days, wound surface basilar part skin island is organized raised, the granulation tissue of about 20 days projections becomes calms down, and the epithelial tissue of visible white is closed to four perithelium island spreading via tissue spaces and reaches healing centered by hair bladder.As 3-degree wound can be shown in that wound surface has liquefied substance for 3 ~ 7 days, slough generally takes off sanies in 2-3 week to be terminated.Substrate about 15 days gradually to rat in " granulation ", part granulation, while epithelial edge spreads, wound surface is dispersed in skin point and spreads gradually, mutually merges and closes and form wound healing.

Below by way of irritation test, observe the present invention further to the zest of skin

1, experimental animal

Get 8 healthy white rabbit, female half and half, by lateral symmetry region, back unhairing 150cm ²sub-cage rearing, observes 24h.Be divided into two large groups at random, first group of intact skin group, second group of damaged skin group (hair-fields sterilization skin of respectively running away like a hare being drawn homalographic # word, the degree of being with oozing of blood, as damaged skin group with scalpel).

2, test method

Adopt consubstantiality left and right sides own control, the left dorsal often organizing rabbit is coated with the faster cream 1ml of skin infection of the present invention, and the right side back of the body is coated with moist expose burn ointment 1ml, administration every day 1 time, continuous 7d, each remove medicine after 1h and observing before again sticking and situation such as record erythema and edema etc.After last sticks, 1h, 24h, 48h and 72h perusal after removal medicine also records coating part with or without the situation such as erythema and edema.

3, result of the test

The faster cream group of skin infection of the present invention and the continuous 7d of moist expose burn ointment matched group give the complete of rabbit and damaged skin, all do not find obvious erythema and edema reaction, Continuous Observation 10d, each rabbit skin health, vacuum response occurs, and shows that the faster cream of skin infection of the present invention all has no stimulation to the complete of rabbit and damaged skin.

Toxicity profile of the present invention is observed further below by way of skin sensibiligen test

1, experimental animal

Get 12 healthy white rabbit, female half and half, by lateral symmetry region, back unhairing 150cm2 sub-cage rearing, observe 24h.

2, test method

Above-mentioned rabbit is divided into three groups, first group of intact skin group by study of tcm new drug guide (pharmacy, pharmacology, toxicology) at random that issue with reference to bureau of drug administration of Ministry of Health of the People's Republic of China, gives the faster cream clinical equivalent of skin infection 4 times of concentration; Second group of damaged skin group (hair-fields sterilization skin of respectively running away like a hare being drawn homalographic # word, the degree of being with oozing of blood, as damaged skin group with scalpel), gives the faster cream clinical equivalent of skin infection 4 times of concentration; 3rd group of matched group, gives moist expose burn ointment.Dosage is 2ml/ time, in 24h, interval administration amounts to 3 times, depilation district, left side is evenly applied to by reagent, give by after reagent 24h, wash away residue, and in 1,24,48,72h to d7, the situation of the systems such as the change of each rabbit body weight of observed and recorded every day, skin and hair, eye and mucosa and breathing, central nervous system, quadruped locomotion.

3, result of the test

Administration 1h, observes the skin of each treated animal, hair, mucosa after 24h, 48h, 72h to 7d, breathe, circulation, nervous system, and extremity activity etc. is showed no ANOMALOUS VARIATIONS, and be poisoned to death without animal, damaged skin group also has no obvious inflammatory reaction and performance of suppurating.Before following table 1 observes administration and after administration 7d, each group rabbit body weight change no significant difference.

The faster cream of table 1 skin infection is on the impact of the acute toxicity test body weight of rabbit skin

Result of the test shows, the faster cream high dose group of skin infection and moist expose burn ointment matched group respectively observe 7d to intact skin and damaged skin rabbit, does not occur any acute toxic reaction (P > 0.05).

The sensitivity of the present invention to skin is observed further below by way of skin anaphylactic test.

1, experimental animal

Extracting waste Cavia porcellus 40, by its back lateral symmetry unhairing, area is 3cm*3cm, sub-cage rearing, observe 1d, be divided into 4 groups at random by male and female half and half, A group to the faster cream low dosage of skin infection, B group to the faster cream high dose of skin infection, C group to moist expose burn ointment contrast, D group is to positive control medicine DNF.Each group is carried out sensitization contact respectively in depilation district, both sides and contacts administration with exciting.

2, test method

With reference to the study of tcm new drug guide (pharmacy, pharmacology, toxicology) that bureau of drug administration of Ministry of Health of the People's Republic of China issues.

Sensitization contact: will by the faster cream of test product low dosage skin infection, the faster cream of high dose skin infection, moist expose burn ointment matched group, 0.1%2 by different groups, 4-dinitrofluorobenzene 0.2ml/ time, 1 times/day is applied to district of losing hair or feathers on the left of guinea pig back, and 7d and 14d respectively repeats 1 time in the same way.

Excite contact: in last to by 14d after test product sensitization, with the faster cream of low dosage skin infection, the faster cream of high dose skin infection, moist expose burn ointment, 0.1%2,4-dinitrofluorobenzene 0.2ml/ time, be applied to unhairing district on the right side of corresponding tested group of Cavia porcellus respectively, residue is washed away after contact 6h, at once observe, then observe skin again with or without skin allergy situation and systemic conditions such as redness, edema in 24h, 48h, 72h.

3, result of the test

The faster cream of table 2 skin infection is to the sensitization test (STT) (sensitization contact) of guinea pig skin

The faster cream of table 3 skin infection is to the sensitization test (STT) (exciting contact) of guinea pig skin

With reference to " standards of grading of skin allergy degree " and " hypersensitive evaluation criterion " in the study of tcm new drug guide (pharmacy, pharmacology, toxicology) that bureau of drug administration of Ministry of Health of the People's Republic of China issues, scoring statistics is carried out to protocol, the results are shown in Table 2 and table 3.Result of the test shows, compared with matched group and positive controls, the faster cream of skin infection (high dose group, low dose group) outward for guinea pig skin, without anaphylaxis.(P＞0.05)

In sum, this ointment is in burn wound's treatment, be conducive to epithelialization and wound healing, extensive deep burn slough can be impelled to degenerate and to come off and toxin excretion, and can effective kill bacteria, corruption goes flesh raw, the flat skin of skin is long, blood follows enhancing, the cell that effective nutrition is impaired, improve hypoxic-ischemic and the malnutrition of local organization, alleviate cicatrix growth, make poison, rotten, the stasis of blood, empty pathology is effectively improved, local gasification is made to recover normal, make damaged tissues newborn and heal rapidly, and burn patient can be reduced lose some benefits, cut crust, the financial burden of the misery that the operations such as skin-grafting bring and great number.To trample and zoopery shows through clinical: it is fast that this ointment has sterilization reducing swelling and alleviating pain, short treating period, wound healing is fast, either shallow does not stay scar, and the degree of depth is not made skin graft, no pain of changing dressings, the magical curative effects such as wound surface and dressing do not adhere to, and without skin irritation, avirulence and skin hypersensitivity reaction, clinic application.

Claims

1. treat an external application Chinese medicine ointment for sores ulceration of skin, it is characterized in that: the material used is as follows, the Radix Astragali, Radix Angelicae Sinensis, Cortex Phellodendri, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Zanthoxyli, Rhizoma Paridis, Fructus Gardeniae, the Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Boehmeriae, Corium elephatis, Herba Selaginellae, Borneolum Syntheticum, Cera Flava, Oleum Brassicae campestris, stearic acid, glycerol, glyceryl monostearate, hexadecanol, potassium hydroxide, ethyl hydroxybenzoate, distilled water.

2. according to the external application Chinese medicine ointment for the treatment of sores ulceration of skin described in claim 1, it is characterized in that: Radix Astragali 450-550g, Radix Angelicae Sinensis 400-600g, Cortex Phellodendri 400-600g, Radix Scutellariae 450-550g, Radix Et Rhizoma Rhei 450-550g, Radix Zanthoxyli 350-550g, Rhizoma Paridis 400-600g, Fructus Gardeniae 480-600g, Pseudobulbus Bletillae (Rhizoma Bletillae) 450-600g, Radix Boehmeriae 450-550g, Corium elephatis 100-300g, Herba Selaginellae 400-600g, Borneolum Syntheticum 25-30g, Cera Flava 250-400g, Oleum Brassicae campestris 2000-3000g, stearic acid 450-550g, glycerol 450-550g, glyceryl monostearate 50-100g, hexadecanol 100-200g, potassium hydroxide 45-55g, ethyl hydroxybenzoate 20-30g, distilled water 3700-3800g.

3. according to the external application Chinese medicine ointment for the treatment of sores ulceration of skin described in claim 2, it is characterized in that: optimum weight proportion is as follows, Radix Astragali 500g, Radix Angelicae Sinensis 500g, Cortex Phellodendri 500g, Radix Scutellariae 500g, Radix Et Rhizoma Rhei 500g, Radix Zanthoxyli 500g, Rhizoma Paridis 500g, Fructus Gardeniae 500g, Pseudobulbus Bletillae (Rhizoma Bletillae) 500g, Radix Boehmeriae 500g, Corium elephatis 200g, Herba Selaginellae 500g, Borneolum Syntheticum 20g, Cera Flava 350g, Oleum Brassicae campestris 2500g, stearic acid 500g, glycerol 500g, glyceryl monostearate 75g, hexadecanol 150g, potassium hydroxide 50g, ethyl hydroxybenzoate 25g, distilled water 3750g.