CN105106475A - Traditional Chinese medicine gel used for treating toxin-accumulating rotting and ulcerating type bedsores during clinical nursing - Google Patents

Traditional Chinese medicine gel used for treating toxin-accumulating rotting and ulcerating type bedsores during clinical nursing Download PDF

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CN105106475A
CN105106475A CN201510622982.2A CN201510622982A CN105106475A CN 105106475 A CN105106475 A CN 105106475A CN 201510622982 A CN201510622982 A CN 201510622982A CN 105106475 A CN105106475 A CN 105106475A
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herba
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carbomer
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不公告发明人
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Qingdao Yuntian Biotechnology Co Ltd
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Abstract

The invention belongs to the field of traditional Chinese medicine and traditional Chinese medicine gel used for treating toxin-accumulating rotting and ulcerating type bedsores during clinical nursing. The traditional Chinese medicine gel is prepared with 1-10 parts of clear paste, 1-10 parts of Carbomer, 2-10 parts of triethanolamine, 5-20 parts of glycerol, 30-70 parts of alcohol, 3-10 parts of polyoxyethylene hydrogenated castor oil, 0.01-0.5 part of sodium bisulfite, 0.01-0.5 part of ethylene diamine tetraacetic acid, 1-10 parts of azone and 100-200 parts of purified water, wherein the clear paste is prepared with veronicastrum caulopterum, sticktight, Zouyoucao, large-leaved caesalpinia, lobedfruit schizocapsa rhizome, cyrtophyllum root, sansevieria and Chinese honeylocust spine. The traditional Chinese medicine gel has efficacy of clearing heat for detoxification, activating blood to remove blood stasis, removing slough and promoting tissue regeneration, diminishing inflammation and stopping pain, can effectively control growing and breeding of infectious pathogens, improve microcirculation around the surface of a wound, increase local blood flow, promote growth of granulation tissue and accelerate heating, and is a good scheme for treating the toxin-accumulating rotting and ulcerating type bedsores. The traditional Chinese medicine gel is uniform and exquisite, easy to coat after being unfolded and high in stability.

Description

A kind of clinical care is used for the treatment of the Chinese medicine gel of accumulateing malicious decomposed type decubital ulcer
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of Chinese medicine composition for the treatment of decubital ulcer, especially a kind of clinical care is used for the treatment of the Chinese medicine gel of accumulateing malicious decomposed type decubital ulcer.
Background technology
Decubital ulcer refers to due to local soft tissue continuous compression, hemodynamic responses, causes soft tissue cells hypoxic-ischemic, Nutrition and Metabolism obstacle and the skin mucosa degeneration necrosis occurred.The traditional Chinese medical science has another name called " bed-sore ", and how because of prolonged illness bed, QI-blood circulation is not smooth, failure of skin and muscle to be nourished, skin damage.Contamination is festered and is formed.Be mainly in the apophysis positions such as sacrum tail, heel, femoral greater trochanter, anterior superior iliac spine, capitulum fibulae, external malleolus.Be more common in the prolonged illness sickbed patients such as stupor, paralysis, fracture, large-area burns clinically.Can be divided into by clinical characters and the overall health of patients traditional Chinese medical science: qi stagnation and blood stasis type, accumulate malicious erosive type, QIXUELIANGXU type.Decubital ulcer is once be formed, and the making patients that is bound to is painful, extends the treatment time of protopathy, and increases the weight of financial burden.The elite of the traditional Chinese medical science is determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, decubital ulcer different periods its pathogenesis, performance and method for the treatment of be also when different.
As everyone knows, decubital ulcer belongs to frequently-occurring disease, commonly encountered diseases, easily examines and refractory, is a stubborn problem in clinical care.Cause the reason of decubital ulcer a lot, as pressurized, shearing force and friction, humidity, nutrition of whole body situation etc.Current medical circle treatment means, mainly based on local bactericidal antiphlogistic, adopts antibiotics and sulfa drug more, and needs application antibiotic and the local dressing change of long period.Many Therapeutic Method are the somatic cells by damaging around antibacterial, and the growth controlling antibacterial just can cicatrize a wound, when wound site is in movable joint, or patient's healing ability is poor, nutrition supply is bad, during local microcirculation obstacle, just easily forms prolonged disunion.But these Therapeutic Method are only applicable to slight decubital ulcer, decubital ulcer is festered, slough and pus more to accumulate malicious decomposed card healing effect poor, and antibiotic medicine is all without Nutrition, can not local microcirculation be improved, while killing antibacterial, damage surrounding healthy cells.Modern medicine circle also adopts some liniments, promote that muscle growth and epidermis heal, such as Shengji Yuhong Gao, rubber plaster etc., but because they do not have inflammation-diminishing function, and poor with the antiphlogistic antibacterial element adaptability of Western medicine, easily cause healing inside, surface still to there is septicopyemia problem, cause wound obstinate, or bad during fashion.
External treatment with Chinese medicine treatment primary disease is followed: " method of surgery, the heaviest external treatment ", " reason of external treatment, the i.e. reason for the treatment of by oral administration of medicines; The medicine of external treatment that is the medicine for the treatment of by oral administration of medicines, different person's method ear " classical theory of external therapy.Gel is a kind of Novel external dosage form, be applicable to skin, mucosa and tract, the first-pass effect such as enzyme, acid in the gastrointestinal tract not only avoiding oral administration to exist, the toxic and side effects of medicine can be alleviated simultaneously, and preparation is easier, the drug type that can hold is comparatively wide, meets the theory of " inner disease outer treat ".
Summary of the invention
Inventor has clinical syndrome differentiation opinion for many years to control the experience of pressure ulcer, persistent pursuit is had to the modernization of Chinese medicine, kind based on Chinese medicinal formulae, technological innovation is carried out in conjunction with modern new dressing and new technique, from sturdy clinical research accumulation, extract a kind of clinical care be used for the treatment of the Chinese medicine gel of accumulateing malicious decomposed type decubital ulcer, this gel has effect of heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, subduing swelling and relieving pain, putrefaction-removing granulation-promoting, good effect, easy to use.
For achieving the above object, the present invention adopts following technical scheme:
A kind of clinical care is used for the treatment of the Chinese medicine gel of accumulateing malicious decomposed type decubital ulcer, it is by clear paste 1-10 part, carbomer 1-10 part, triethanolamine 2-10 part, glycerol 5-20 part, ethanol 30-70 part, polyoxyethylene hydrogenated Oleum Ricini 3-10 part, sodium sulfite 0.01-0.5 part, disodiumedetate 0.01-0.5 part, azone 1-10 part, purified water 100-200 part is made;
Described clear paste is made up of following raw material: Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae;
Wherein, solid constituent with the corresponding relation of liquid components is: solid part unit is liquid part unit that g is corresponding is mL, or solid part unit be liquid part unit that Kg is corresponding is L.
Carbomer: be the high molecular polymer of acrylic acid bonding allyl sucrose or tetramethylolmethane allyl ether.Calculate by dry product, should be 56.0% ~ 68.0% containing carboxylic acid group (-COOH).Card ripple after neutralization is outstanding gel-type vehicle, has the important function such as thickening, suspension.Main model has: carbomer 910,934,934P, 940,941,954,971P, 974P, 980,981 etc.
Preferably, the carbomer that the present invention is used is carbomer 910,934,940; Most preferably carbomer 910, the gel after making is easy to coating, and energy absorptive tissue transudate, be conducive to the eliminating of secretions, special Suitable therapeutic accumulates malicious decomposed type decubital ulcer.
In order to increase the chemiluminescence of effective active composition in clear paste, to reach better therapeutic effect, preferably, described clear paste is processed by the crude drug of following weight parts and is prepared from: Herba Veronicastri caulopteri 9-19 part, Herba Bidentis Bipinnatae 15-30 part, Herba Seu Radix Tetrastigmatis Obtecti 10-20 part, Ramulus seu Fructus Caesalpiniae 10-20 part, Rhizoma Schizocapsae Plantagineae 5-12 part, Radix Clerodenri Cyrtophylli 13-18 part, Folium Sansevieriae Trifasclatae 11-16 part, Spina Gleditsiae 3-9 part.
Further preferably, clear paste described above is processed by the crude drug of following weight parts and is prepared from: Herba Veronicastri caulopteri 11-15 part, Herba Bidentis Bipinnatae 23-27 part, Herba Seu Radix Tetrastigmatis Obtecti 15-20 part, Ramulus seu Fructus Caesalpiniae 12-16 part, Rhizoma Schizocapsae Plantagineae 9-11 part, Radix Clerodenri Cyrtophylli 14-16 part, Folium Sansevieriae Trifasclatae 13-16 part, Spina Gleditsiae 5-7 part.
Further preferably, one of the better prescription of clear paste described above is: Herba Veronicastri caulopteri 13 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 16 parts, Ramulus seu Fructus Caesalpiniae 14 parts, Rhizoma Schizocapsae Plantagineae 9 parts, Radix Clerodenri Cyrtophylli 15 parts, Folium Sansevieriae Trifasclatae 15 parts, Spina Gleditsiae 6 parts.
Prescription analysis: side in the Herba Veronicastri caulopteri of bitter cold, Herba Bidentis Bipinnatae for monarch drug, heat-clearing and toxic substances removing, expelling wind and removing dampness, promoting blood circulation and detumescence pain relieving.Assistant is with pungent using warming therapy Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae promoting blood circulation to remove obstruction in the collateral, promoting the circulation of blood intestinal stasis relieving, expelling wind and removing dampness, removing toxic substances and promoting subsidence of swelling, and Ramulus seu Fructus Caesalpiniae sweet in the mouth can be mended, and has certain temperature compensation effect, and use with migration grass compatibility, putrefaction removing and tissue regeneration promoting power is strong, is ministerial drug.Be aided with Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli removing pathogenic heat from blood and toxic substance from the body, dissipating blood stasis for subsidence of swelling; Folium Sansevieriae Trifasclatae is heat-clearing and toxic substances removing both, again promoting blood circulation and detumescence, principal drug assistance heat-clearing and toxic substances removing, removing the necrotic tissue and promoting granulation, is adjuvant drug altogether.The pungent temperature of Spina Gleditsiae, be apt to search wind evacuation of pus, drawing pus and go out, is adjuvant.All medicines both interacted, and were mutually use again, played effect of heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, the evacuation of pus of holder skin ulcer, putrefaction-removing granulation-promoting, subduing swelling and relieving pain altogether.
In order to increase the chemiluminescence between each raw material, the gel obtained reaches better effect, as homogeneous exquisiteness, easily coating after launching, good stability etc., preferably, described gel-type vehicle is made up of the component of following parts by weight: clear paste 3-6 part, carbomer 2.5-4.0 part, triethanolamine 3.0-5.5 part, glycerol 9-16 part, ethanol 50-70 part, polyoxyethylene hydrogenated Oleum Ricini 3-5 part, sodium sulfite 0.05-0.1 part, disodiumedetate 0.05-0.1 part, azone 1-3 part, purified water 120-180 part.
Present invention also offers the preparation method a kind of clinical care being used for the treatment of the Chinese medicine gel of accumulateing malicious decomposed type decubital ulcer, it comprises the following steps:
By Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae mixing, decoct with water 2 ~ 3 times, each amount of water is 6 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.05 ~ 1.08 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 60% ~ 75% (preferred 65%-70%), and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.17 ~ 1.21 (60 DEG C record), obtains described clear paste;
Get recipe quantity sodium sulfite, disodiumedetate is dissolved in suitable quantity of water, under stirring, add recipe quantity carbomer, continue to be stirred to evenly swelling; Get recipe quantity clear paste stirring and dissolving in ethanol, add recipe quantity glycerol, polyoxyethylene hydrogenated Oleum Ricini, azone stir, add the water of surplus, stir to obtain clear paste solution, clear paste solution is joined in the swelling thing of carbomer, stir evenly, add recipe quantity triethanolamine, stir, obtain gel.
In side, the pharmacological property of each raw material is as follows:
Rhizoma Schizocapsae Plantagineae: [nature and flavor] are sweet; Bitter; Cool; Slightly poisonous.[function cures mainly] heat-clearing and toxic substances removing; Eliminating phlegm and stopping cough; Regulating QI to relieve pain; Dissipating blood stasis stops blooding.Main cold, fever; Phlegm-heat cough; Pertussis; Abdominal distention; Dysentery is suffered from abdominal pain; Dyspepsia; Infantile malnutrition; Hepatitis; Laryngopharynx swelling and pain; Toothache; Mumps; Scrofula; Skin ulcer swells; Scald, burn; Herpes zoster; Traumatic injury; Traumatic hemorrhage." Nanning City's medicine is forgotten ": antiinflammatory, removing toxic substances, pain relieving.Control peratodynia, acid regurgitation, cough, Hakuri, pharyngalgia, carbuncle skin ulcer is controlled in external application." the practical Chinese herbal medicine in Guangxi newly selects ": cooling blood and relieving pain, dissipating blood stasis for subsidence of swelling.Control Peptic Ulcers, infantile malnutrition, stomachache, traumatic injury, carbuncle, innominate toxic swelling, gastric heat pain, acute gastroenteritis, toothache.
Herba Veronicastri caulopteri: [nature and flavor] bitter in the mouth; Cold in nature.[function cures mainly] heat-clearing and toxic substances removing; Reducing swelling and alleviating pain.Main mumps; Laryngopharynx swelling and pain; Intestinal is scorching; Dysentery; Lymphoid tuberculosis; Carbuncle kind poison; Eczema; Burn and scald; Traumatic injury.
Ramulus seu Fructus Caesalpiniae: [nature and flavor] Gan Xin; Temperature.[return through] liver; Spleen channel.[function cures mainly] promoting blood circulation and detumescence.Main traumatic injury.
Folium Sansevieriae Trifasclatae: [nature and flavor] are cool; Acid.[function cures mainly] heat-clearing and toxic substances removing; Promoting blood circulation and detumescence.Main flu; Cough due to lung-heat; Sore swollen toxin; Traumatic injury, venom; Burn and scald." Guangxi Chinese herbal medicine ": heat-clearing and toxic substances removing, removing the necrotic tissue and promoting granulation.Cure cold cough, bronchitis, traumatic injury, carbuncle pyogenic infections from tumour or sore, venom.
Herba Bidentis Bipinnatae: [nature and flavor] bitter in the mouth; Cold nature.[function cures mainly] heat-clearing and toxic substances removing; Expelling wind and removing dampness; Promoting blood circulation and detumescence.Main throat; Swell and ache; Have loose bowels; Dysentery; Jaundice; Intestinal carbuncle; Furuncle swelling toxin; Serpentis is early bitten; Rheumatic arthralgia; Traumatic injury.
Spina Gleditsiae: [nature and flavor] are pungent; Temperature.[return through] liver; Lung meridian.[function cures mainly] sterilizes pus; Search wind; Parasite killing.Main swollen ulcer drug; Scrofula; Skin ulcer rash stubborn dermatitis; Puerperal hypogalactia; Placenta retention; Leprosy." book on Chinese herbal medicine converges and says ": Fructus Gleditsia acupuncture, draws out pus by applying a plaster to the affected part and dispels the wind.The non-one-tenth person of all carbuncle, can draw to dissipate, will the person of breaking, can draw to lift one's head, routed person can draw with row pus.Be first want agent in infections poison.
Radix Clerodenri Cyrtophylli: [nature and flavor] are bitter; Cold.[return through] heart; Liver Channel.[function cures mainly] heat clearing away; Removing toxic substances; Removing heat from blood.Main encephalitis b; Epidemic encephalitis; The high heat of flu; Epidemic encephalitis; Parotitis; Heat in blood sends out class; Measles pneumonia; Icteric tripe is scorching; Diarrhea of heat type hematodiarrhoea; Beriberoid pyretic arthralgia; Headache; Laryngopharynx swelling and pain; Acute toothache; Orchitis.Guangzhou army " conventional Chinese herbal medicine handbook ": " dissipating blood stasis stops blooding for clearing away heat-fire, removing pathogenic heat from blood and toxic substance from the body.Control enteritis, bacillary dysentery, pharyngolaryngitis, tonsillitis, parotitis, cold, fever, gingiva bleeding gingival hemorrhage.”
Herba Seu Radix Tetrastigmatis Obtecti: [nature and flavor] are pungent; Temperature.[return through] liver; Spleen; Kidney channel.[function cures mainly] expelling wind and removing dampness; Promoting blood circulation to remove obstruction in the collateral; Removing toxic substances and promoting subsidence of swelling.Main air pain of dampness syndrome; Traumatic injury; Multiple abscess sucutaneous nodule; Carbuncle pyogenic infections from tumour or sore; Venom." Traditional Chinese Medicine in Sichuan will ": disperse rheumatism, promoting the circulation of blood intestinal stasis relieving.Control headache, general pain, bones and muscles pain, rheumatic numbness and multiple abscess; Sore is washed in external.
In order to further illustrate beneficial effect of the present invention, inventors performed a large amount of experimentatioies, comprising the safety evaluation of inventive gel agent, clinical observation on the therapeutic effect test etc.
(1) safety evaluation of Chinese medicine gel of the present invention
1. skin allergy test
Cavia porcellus 30, male and female half and half, body weight 280-320g.Remove both sides, back by hair, area 3cm × 3cm with depilatory before experiment, observe after 24h and determine not damaged.Cavia porcellus after process is divided into three groups at random, often organizes 10.First group to tested material (Chinese medicine gel prepared by the embodiment of the present invention 1), second group of blank (not the substrate of drug containing), 3rd group of positive controls (1% 2,4-dinitro-chloro-benzene solution), then observe evaluating skin allergic conditions respectively at 0h, 24h, 48h, 72h.
Result shows: erythema and edema do not appear in tested group and each 10 guinea pig skins of blank group, occur erythema after positive controls animal skin tested district self-excitation administration 1h, 6h is the most obvious, and 24h disappears gradually, after 72h, erythema is still visible reluctantly, and sensitization rate reaches 100%.Do not occur in 72h after tested group of guinea pig skin tested district self-excitation administration that erythema and edema are formed, compare indifference with blank group, illustrate that Chinese medicine gel of the present invention can not cause skin allergy.
2. skin sensibiligen test
Adult healthy white rabbit 6, before administration, remove animal spinal column both sides by hair, area is about 150cm 2, 24h as a child observed skin with or without situations such as redness, damages, occurred that analogue not easily continues test.The making of damaged skin: after determining epilating area skin situation without exception, with warm water cleaning, iodophor disinfection, draw " # " word with aseptic syringe needle and with oozing of blood degree of being damaged skin.Chinese medicine gel and bare substrate is used to process intact skin and damaged skin white rabbit respectively.Remove tested material with warm water after 24h, observe, then smear identical tested material, continuous 7d.And after last coating 1h, 24h, 48h, 72h, observe every day and record the change of the body weight of animal, skin, hair, eye and mucosa, movable and other poisoning manifestations of breathing, central nervous system, extremity.
Result shows: in multiple dosing experiment, from 1h to the 7th day entry rabbit body weight, skin, hair, eye and mucosa, the change of extremity activity.Chinese medicine gel experimental group and bare substrate matched group and blank group are all without significant difference, and result illustrates that Chinese medicine gel of the present invention is to the complete and equal non-toxic reaction of damaged skin.
(2) stability experiment of Chinese medicine gel of the present invention
According to the medicine stability test guideline of Chinese Pharmacopoeia version in 2010 two annex IU, Acceleration study and room temperature placement experiment are carried out to three batch samples prepared by embodiment 1-3
Acceleration study: sample being placed on relative humidity is 75% ± 5%, temperature is in the closed environment of 40 DEG C ± 2 DEG C 3 months, the 0th, 1,2, March, sampling carries out character observation, microorganism limit detection.
Room temperature places experiment: place relative humidity 60% ± 5%, in temperature 25 ± 2 DEG C of closed environments 3 months, the 0th, 1,2, March, character observation, microorganism limit detection are carried out in sampling.
Result shows: accelerated test 3 months and room temperature place 3 months, and significance change does not all occur for the Chinese medicine gel color of embodiment of the present invention 1-3, texture, granularity; Microorganism detection display total number of bacteria is less than 10/L, mycete do not detected, meets the requirements.
(3) vitro antibacterial activity of Chinese medicine gel of the present invention
Bacterial strain: every each 10 strains of bacterium, are clinical separation; Staphylococcus aureus, staphylococcus epidermidis, bacillus pyocyaneus, escherichia coli, micrococcus scarlatinae, by Shandong, Shandong, hospital provides; Gonorrhea diplococcus is provided by Hospital Attached to Shandong Chinese Medical Univ..
Statistical method: antibacterial experiment statistics are with MIC 50represent, antiinflammatory experimental data statistics adopts t inspection.
Experimental technique: get the embodiment of the present invention 1 prepare gel (every hectogram gel contains crude drug 24 grams) be made into 1:2,1:4,1:8 ..., 1:1024 variable concentrations, two-fold dilution is in various concentration cultures, put 37 DEG C of incubators and cultivate 24h, observe with or without bacterial growth, the highest drug dilution degree do not grown with antibacterial is the minimum inhibitory concentration (MIC) of this medicine, and the MIC according to each bacterium 10 bacterial strains utilizes regression equation to obtain MIC 50, MIC 90.The results are shown in Table 1, gel prepared by the embodiment of the present invention 1 all has antibacterial action in various degree to staphylococcus aureus, staphylococcus epidermidis, escherichia coli, bacillus pyocyaneus, micrococcus scarlatinae, gonorrhea diplococcus.
The vitro antibacterial activity (n=10) of gel prepared by table 1 embodiment of the present invention 1
Bacterial strain MIC 50(mg crude drug/mL) MIC 90(mg crude drug/mL)
Staphylococcus aureus 0.056 0.096
Staphylococcus epidermidis 0.032 0.051
Bacillus pyocyaneus 0.932 1.648
Escherichia coli 0.234 0.408
Micrococcus scarlatinae 0.256 0.432
The two ball of gonorrhea 0.224 0.946
(4) clinical observation test
1. data and method
1.1 physical data: 104 examples selecting my institute to accept for medical treatment in January ,-2015 in January, 2014 accumulate malicious decomposed type patients with bedsore, man 66 example, female 38 example; Age between 55 ~ 85, average (68.5 ± 5.8) year; Protopathy comprises the common complication of other sections paralysis such as fracture is rear, apoplexy sequela, chronic obstructive pneumonia and long-term bedridden patients, the maximum 15cm × 18cm of decubital ulcer area, minimum 3cm × 4cm, average (33.06 ± 8.24) cm 2.Be divided into treatment group and matched group at random by 1:1, the item indexs such as two groups of Genders, age, decubitus ulcer areas, through statistical procedures no significant difference, have comparability (P > 0.05).
1.2 diagnostic criterias are according to the formulation of " People's Republic of China's traditional Chinese medicine industry standard--Chinese medical disease Standardization of diagnosis and curative effect (YZ/T001.1-94) " decubital ulcer: be apt to occur in the apophysis such as tail sacrum, ridge, elbow ankle and easily suffer oppression and the position that rubs; From the beginning of skin occurring brown erythema, micro-swollen, purple dark edema then, necrosis is festered; During secondary contamination, tissue necrosis is rapid, and pus is dripping, corresponding site Bing Fa Xing core pain; Be more common in the patient of the prolonged illness beds such as stupor, paralysis, fracture, large-area burns.
1.3 tcm syndrome classification accumulate malicious decomposed card according to the formulation of " People's Republic of China's traditional Chinese medicine industry standard--Chinese medical disease Standardization of diagnosis and curative effect (YZ/T001.1-94) " decubital ulcer: decubital ulcer is festered, slough and pus more, or foul smelling, severe one is festered can deeply and muscles and bones, and surrounding is unrestrained swollen.With heating or low grade fever, bitter taste and dry, body and the spirit is dispirited, anorexia etc.Red tongue, tongue is few, thready and rapid pulse.
1.4. Therapeutic Method:
Matched group: application traditional remedies treatment.First clean wound surface with hydrogen peroxide, iodophor disinfection, remove slough as far as possible, reach that wound surface is fresh ruddyly hemorrhagely to be enriched for standard, then with 0.9% sodium chloride injection cleaning, iodophor disinfection, sterile gauze covers, every day 1 time, 7 days courses for the treatment of.
Treatment group: be applied on wound surface by gel prepared by the embodiment of the present invention 1 on treatment of control group debridement basis, every day changes dressings 1-2 time.
All treat three weeks, compare curative effect for two groups.
1.5 efficacy evaluations are according to the formulation of " People's Republic of China's traditional Chinese medicine industry standard--Chinese medical disease Standardization of diagnosis and curative effect (YZ/T001.1-94) " decubital ulcer: recovery from illness: wound surface all healed, without false healing phenomenons such as empyemas under crust.Effective: wound surface area reduces the scope > 75%, and without purulent secretion, granulation tissue is fresh, and color is scarlet.Effective: wound surface area reduces the scope > 25%, and obviously reduce without purulent secretion or purulent secretion, granulation tissue color is red.Invalid: wound surface area reduces the scope < 25%, wound surface purulent secretion is without obvious minimizing, and granulation tissue color is dark, and wound surface is without obviously reducing trend.Effective percentage=(recovery from illness+effective)/total number of cases × 100%.
1.6 statistical procedures: application SPSS16.0 statistical software.Measurement data with represent, and t inspection is adopted to data.P < 0.05 has statistical significance for difference.
2. result
2.1. two groups of Clinical efficacy comparisons after three courses for the treatment of: treatment group recovery from illness 20 example, effective 27 examples, total effective rate 92.0%; Matched group recovery from illness 11 example, effective 17 examples, total effective rate 66.7%, two groups of total effective rate comparing differences have statistical significance (P < 0.05), and treatment group curative effect is obviously better than matched group, in table 2.
Table 2: two groups of Clinical efficacy comparisons after two courses for the treatment of: example (%)
Note: compare with matched group, * P < 0.05.
Can find that treatment group is apparently higher than matched group, illustrates thus by the treatment total effective rate contrasting two groups of patients, the present invention accumulates malicious decomposed type decubital ulcer in treatment and has good clinical effectiveness, effectively can improve the cure rate for the treatment of, be worth promoting in clinical practice.
In a word, the present invention has following beneficial effect: in inventive gel agent, 8 taste Chinese crude drugs interact, again mutually for using, play effect of heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, the evacuation of pus of holder skin ulcer, putrefaction-removing granulation-promoting, subduing swelling and relieving pain altogether, can the Growth and reproduction of effective infection control pathogen, improve microcirculation around wound surface simultaneously, increase regional flow, promote granulation tissue growth, accelerate healing; Inventive gel agent uniform and smooth, easily coating after launching, holdup time long not skin tightening again, good stability.
Detailed description of the invention
Further describe the present invention below by way of detailed description of the invention, but the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the present invention is suitably improved, replaces the identical component of effect, will become apparent to those skilled in the art that they are all deemed to be included within scope of the present invention.
The Selection experiment of gelatum skeleton material
Gel formula: clear paste 4 parts, carbomer 3 parts, triethanolamine 3.5 parts, glycerol 10 parts, ethanol 55 parts, polyoxyethylene hydrogenated Oleum Ricini 3.5 parts, sodium sulfite 0.06 part, disodiumedetate 0.06 part, azone 1.3 parts, purified water 150 parts.
Clear paste formula: Herba Veronicastri caulopteri 13 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 16 parts, Ramulus seu Fructus Caesalpiniae 14 parts, Rhizoma Schizocapsae Plantagineae 9 parts, Radix Clerodenri Cyrtophylli 15 parts, Folium Sansevieriae Trifasclatae 15 parts, Spina Gleditsiae 6 parts.
Solid constituent with the corresponding relation of liquid components is: solid part unit is liquid part unit that g is corresponding is mL, or solid part unit be liquid part unit that Kg is corresponding is L.
Preparation method: by Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae mixing, decoct with water 2 ~ 3 times, each amount of water is 6 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.07 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 66%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.19 (60 DEG C record), obtains described clear paste;
Get recipe quantity sodium sulfite, disodiumedetate is dissolved in suitable quantity of water, under stirring, add recipe quantity carbomer, continue to be stirred to evenly swelling; Get recipe quantity clear paste stirring and dissolving in ethanol, add recipe quantity glycerol, polyoxyethylene hydrogenated Oleum Ricini, azone stir, add the water of surplus, stir to obtain clear paste solution, clear paste solution is joined in the swelling thing of carbomer, stir evenly, add recipe quantity triethanolamine, stir, obtain gel.
Carbomer selects carbomer 910, carbomer 934, Acritamer 940 respectively, makes gel substrate according to formula ratio, investigates the mouldability of substrate, hydrophilic, viscous sense, stretchability four indexs, thus optimizes carbomer model.The results are shown in Table 3.
The different carbomer model of table 3 makes the performance comparison of gel substrate
Performance indications Carbomer 910 Carbomer 934 Acritamer 940
Mouldability Good Generally Good
Hydrophilic By force By force By force
Viscous sense Nothing Nothing Have
Stretchability Very well Good Very well
Note: mouldability classification: good, general, poor; Hydrophilic classification: strong, general, poor; Viscous sense: to have, nothing; Stretchability: fine, good, general, poor.
Visible, using carbomer 910 as gelatum skeleton material, the gel substrate mouldability made, hydrophilic be strong, be easy to coating and without viscous sense.And experiment finds, carbomer 910 complete swelling is short, also greatly can shorten manufacturing cycle.
Embodiment 1
Gel formula: clear paste 4 parts, carbomer (910) 3 parts, triethanolamine 3.5 parts, glycerol 10 parts, ethanol 55 parts, polyoxyethylene hydrogenated Oleum Ricini 3.5 parts, sodium sulfite 0.06 part, disodiumedetate 0.06 part, azone 1.3 parts, purified water 150 parts.
Clear paste formula: Herba Veronicastri caulopteri 13 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 16 parts, Ramulus seu Fructus Caesalpiniae 14 parts, Rhizoma Schizocapsae Plantagineae 9 parts, Radix Clerodenri Cyrtophylli 15 parts, Folium Sansevieriae Trifasclatae 15 parts, Spina Gleditsiae 6 parts.
Preparation method: by Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae mixing, decoct with water 2 ~ 3 times, each amount of water is 6 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.07 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 66%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.19 (60 DEG C record), obtains described clear paste;
Get recipe quantity sodium sulfite, disodiumedetate is dissolved in suitable quantity of water, under stirring, add recipe quantity carbomer, continue to be stirred to evenly swelling; Get recipe quantity clear paste stirring and dissolving in ethanol, add recipe quantity glycerol, polyoxyethylene hydrogenated Oleum Ricini, azone stir, add the water of surplus, stir to obtain clear paste solution, clear paste solution is joined in the swelling thing of carbomer, stir evenly, add recipe quantity triethanolamine, stir, obtain gel.
Embodiment 2
Gel formula: clear paste 4 parts, carbomer 3.0 parts, triethanolamine 4.0 parts, glycerol 10 parts, ethanol 58 parts, polyoxyethylene hydrogenated Oleum Ricini 3.5 parts, sodium sulfite 0.0 part, disodiumedetate 0.05 part, azone 1.5 parts, purified water 150 parts.
Clear paste formula: Herba Veronicastri caulopteri 12 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 15 parts, Ramulus seu Fructus Caesalpiniae 12 parts, Rhizoma Schizocapsae Plantagineae 10 parts, Radix Clerodenri Cyrtophylli 14 parts, Folium Sansevieriae Trifasclatae 14 parts, Spina Gleditsiae 5.5 parts.
Preparation method: by Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae mixing, decoct with water 2 ~ 3 times, each amount of water is 6 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.05 ~ (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 65%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.17 (60 DEG C record), obtains described clear paste;
Get recipe quantity sodium sulfite, disodiumedetate is dissolved in suitable quantity of water, under stirring, add recipe quantity carbomer, continue to be stirred to evenly swelling; Get recipe quantity clear paste stirring and dissolving in ethanol, add recipe quantity glycerol, polyoxyethylene hydrogenated Oleum Ricini, azone stir, add the water of surplus, stir to obtain clear paste solution, clear paste solution is joined in the swelling thing of carbomer, stir evenly, add recipe quantity triethanolamine, stir, obtain gel.
Embodiment 3
Gel formula: clear paste 3 parts, carbomer 2.5 parts, triethanolamine 3.5 parts, glycerol 9 parts, ethanol 60 parts, polyoxyethylene hydrogenated Oleum Ricini 3 parts, sodium sulfite 0.08 part, disodiumedetate 0.08 part, azone 2 parts, purified water 170 parts.
Clear paste formula: Herba Veronicastri caulopteri 15 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 20 parts, Ramulus seu Fructus Caesalpiniae 15 parts, Rhizoma Schizocapsae Plantagineae 11 parts, Radix Clerodenri Cyrtophylli 15 parts, Folium Sansevieriae Trifasclatae 16 parts, Spina Gleditsiae 6.5 parts.
Preparation method: by Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae mixing, decoct with water 2 ~ 3 times, each amount of water is 6 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.08 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 70%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 (60 DEG C record), obtains described clear paste;
Get recipe quantity sodium sulfite, disodiumedetate is dissolved in suitable quantity of water, under stirring, add recipe quantity carbomer, continue to be stirred to evenly swelling; Get recipe quantity clear paste stirring and dissolving in ethanol, add recipe quantity glycerol, polyoxyethylene hydrogenated Oleum Ricini, azone stir, add the water of surplus, stir to obtain clear paste solution, clear paste solution is joined in the swelling thing of carbomer, stir evenly, add recipe quantity triethanolamine, stir, obtain gel.
Embodiment 4
Gel formula: clear paste 4 parts, carbomer (910) 3 parts, triethanolamine 3.5 parts, glycerol 10 parts, ethanol 55 parts, polyoxyethylene hydrogenated Oleum Ricini 3.5 parts, sodium sulfite 0.06 part, disodiumedetate 0.06 part, azone 1.3 parts, purified water 150 parts.
Clear paste formula: Herba Veronicastri caulopteri 12 parts, Herba Bidentis Bipinnatae 20 parts, Herba Seu Radix Tetrastigmatis Obtecti 12 parts, Ramulus seu Fructus Caesalpiniae 12 parts, Rhizoma Schizocapsae Plantagineae 8 parts, Radix Clerodenri Cyrtophylli 15 parts, Folium Sansevieriae Trifasclatae 13 parts, Spina Gleditsiae 4 parts.
Preparation method: with reference to the operation of embodiment 1-3.
Embodiment 5
Gel formula: clear paste 3.5 parts, carbomer (910) 3.5 parts, triethanolamine 4.5 parts, glycerol 10 parts, ethanol 60 parts, polyoxyethylene hydrogenated Oleum Ricini 3.5 parts, sodium sulfite 0.05 part, disodiumedetate 0.06 part, azone 1.5 parts, purified water 150 parts.
Clear paste formula: Herba Veronicastri caulopteri 15 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 20 parts, Ramulus seu Fructus Caesalpiniae 15 parts, Rhizoma Schizocapsae Plantagineae 12 parts, Radix Clerodenri Cyrtophylli 16 parts, Folium Sansevieriae Trifasclatae 12 parts, Spina Gleditsiae 5 parts.
Preparation method: with reference to the operation of embodiment 1-3.
Embodiment 6
Gel formula: clear paste 5 parts, carbomer (910) 3.5 parts, triethanolamine 5.0 parts, glycerol 15 parts, ethanol 65 parts, polyoxyethylene hydrogenated Oleum Ricini 3.5 parts, sodium sulfite 0.06 part, disodiumedetate 0.08 part, azone 2.0 parts, purified water 180 parts.
Clear paste formula: Herba Veronicastri caulopteri 15 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 20 parts, Ramulus seu Fructus Caesalpiniae 15 parts, Rhizoma Schizocapsae Plantagineae 10 parts, Radix Clerodenri Cyrtophylli 16 parts, Folium Sansevieriae Trifasclatae 12 parts, Spina Gleditsiae 6 parts.
Preparation method: with reference to the operation of embodiment 1-3.

Claims (7)

1. a clinical care is used for the treatment of the Chinese medicine gel of accumulateing malicious decomposed type decubital ulcer, it is characterized in that by clear paste 1-10 part, carbomer 1-10 part, triethanolamine 2-10 part, glycerol 5-20 part, ethanol 30-70 part, polyoxyethylene hydrogenated Oleum Ricini 3-10 part, sodium sulfite 0.01-0.5 part, disodiumedetate 0.01-0.5 part, azone 1-10 part, purified water 100-200 part is made;
Described clear paste is made up of following raw material: Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae;
Wherein, solid constituent with the corresponding relation of liquid components is: solid part unit is liquid part unit that g is corresponding is mL, or solid part unit be liquid part unit that Kg is corresponding is L.
2. Chinese medicine gel as claimed in claim 1, is characterized in that described clear paste is made up of the raw material of following weight parts: Herba Veronicastri caulopteri 9-19 part, Herba Bidentis Bipinnatae 15-30 part, Herba Seu Radix Tetrastigmatis Obtecti 10-20 part, Ramulus seu Fructus Caesalpiniae 10-20 part, Rhizoma Schizocapsae Plantagineae 5-12 part, Radix Clerodenri Cyrtophylli 13-18 part, Folium Sansevieriae Trifasclatae 11-16 part, Spina Gleditsiae 3-9 part.
3. Chinese medicine gel as claimed in claim 2, is characterized in that described clear paste is made up of the raw material of following preferred weight part: Herba Veronicastri caulopteri 11-15 part, Herba Bidentis Bipinnatae 23-27 part, Herba Seu Radix Tetrastigmatis Obtecti 15-20 part, Ramulus seu Fructus Caesalpiniae 12-16 part, Rhizoma Schizocapsae Plantagineae 9-11 part, Radix Clerodenri Cyrtophylli 14-16 part, Folium Sansevieriae Trifasclatae 13-16 part, Spina Gleditsiae 5-7 part.
4. Chinese medicine gel as claimed in claim 3, is characterized in that described clear paste is made up of the raw material of following preferred weight part: Herba Veronicastri caulopteri 13 parts, Herba Bidentis Bipinnatae 25 parts, Herba Seu Radix Tetrastigmatis Obtecti 16 parts, Ramulus seu Fructus Caesalpiniae 14 parts, Rhizoma Schizocapsae Plantagineae 9 parts, Radix Clerodenri Cyrtophylli 15 parts, Folium Sansevieriae Trifasclatae 15 parts, Spina Gleditsiae 6 parts.
5. the Chinese medicine gel as described in claim 1-4, it is characterized in that by clear paste 3-6 part, carbomer 2.5-4.0 part, triethanolamine 3.0-5.5 part, glycerol 9-16 part, ethanol 50-70 part, polyoxyethylene hydrogenated Oleum Ricini 3-5 part, sodium sulfite 0.05-0.1 part, disodiumedetate 0.05-0.1 part, azone 1-3 part, purified water 120-180 part is made.
6. the Chinese medicine gel as described in claim 1-5, it is characterized in that in the preferred carbomer 910 of described carbomer, carbomer 934, Acritamer 940 one or more, most preferably carbomer 910.
7. the Chinese medicine gel as described in claim 1-6, is characterized in that preparation method comprises the following steps:
By Herba Veronicastri caulopteri, Herba Bidentis Bipinnatae, Herba Seu Radix Tetrastigmatis Obtecti, Ramulus seu Fructus Caesalpiniae, Rhizoma Schizocapsae Plantagineae, Radix Clerodenri Cyrtophylli, Folium Sansevieriae Trifasclatae, Spina Gleditsiae mixing, decoct with water 2 ~ 3 times, each amount of water is 6 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.05 ~ 1.08 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 60% ~ 75% (preferred 65%-70%), and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.17 ~ 1.21 (60 DEG C record), obtains described clear paste;
Get recipe quantity sodium sulfite, disodiumedetate is dissolved in suitable quantity of water, under stirring, add recipe quantity carbomer, continue to be stirred to evenly swelling; Get recipe quantity clear paste stirring and dissolving in ethanol, add recipe quantity glycerol, polyoxyethylene hydrogenated Oleum Ricini, azone stir, add the water of surplus, stir to obtain clear paste solution, clear paste solution is joined in the swelling thing of carbomer, stir evenly, add recipe quantity triethanolamine, stir, obtain gel.
CN201510622982.2A 2015-09-25 2015-09-25 Traditional Chinese medicine gel used for treating toxin-accumulating rotting and ulcerating type bedsores during clinical nursing Withdrawn CN105106475A (en)

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Publication number Priority date Publication date Assignee Title
CN111053809A (en) * 2019-12-31 2020-04-24 中国医学科学院药用植物研究所 Health care product for adjuvant treatment of herpes zoster and preparation method thereof

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CN102793830A (en) * 2012-08-15 2012-11-28 中山市中医院 Pronephrium triphyllum-rheum officinale gel and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102793830A (en) * 2012-08-15 2012-11-28 中山市中医院 Pronephrium triphyllum-rheum officinale gel and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111053809A (en) * 2019-12-31 2020-04-24 中国医学科学院药用植物研究所 Health care product for adjuvant treatment of herpes zoster and preparation method thereof

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Application publication date: 20151202