CN105106459A - Traditional Chinese medicine gelling agent for treating superficial ulcer stage pressure sores and preparation method thereof - Google Patents

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine gelling agent for treating superficial ulcer stage pressure sores and a preparation method thereof. Clear paste used in the traditional Chinese medicine gelling agent is prepared from the following raw materials: ramulus mori, purpleflower holly leaves, aristolochia impressinervis, caulis impatientis, red beans, serissa serissoide, akebia trifoliate and radix et rhizoma thalictri; the functions of clearing away heat and toxic materials, inducing diuresis for removing edema and expelling the stasis for the new are achieved, the prepared gelling agent is easy to smear and spread, has good affinity with skin, can slowly and stably release drugs, and is beneficial for improvement of the drug bioavailability. The traditional Chinese medicine gelling agent prepared by adopting the preparation method can also improve the wound peripheral microcirculation, improve regional blood flow, relieve inflammatory edema, regional tissue ischaemia and oxygen deficit, reduce inflammatory exudation, promote inflammatory absorption and resolution, does not cause skin allergy, and is safe in use.

Description

A kind ofly treat Chinese medicine gel of either shallow ulcerative stage pressure ulcer and preparation method thereof

Technical field

The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine composition for the treatment of pressure ulcer, especially a kind ofly treat Chinese medicine gel of either shallow ulcerative stage pressure ulcer and preparation method thereof.

Background technology

Pressure ulcer, also known as pressure ulcer, is one of clinical common complication, and being affects blood circulation, continuous ischemia, anoxia, malnutrition due to the long-time pressurized of body local, and the soft tissue caused festers and necrosis.The generation of pressure ulcer will increase misery to patient, increase the weight of the state of an illness, and extend the course of disease, severe patient can cause septicemia and jeopardize patients ' lives.

Pressure ulcer belongs to the category such as " decubital ulcer ", " bed-sore " in the traditional Chinese medical science, is more common in the patient of the long-term beds such as stupor, hemiplegia, fracture or lower extremity paralysis.Be apt to occur in the position easily suffering oppression and rub, as positions such as sacrum tail, the back of the body, shoulder, elbow, heel and inside and outside ankles.From the beginning of visible pressurized position skin rubefaction, purple dark, and have red, swollen, hot, pain or numbness, occur the shallow table ulcer of limitation, surrounding skin swells the smooth undiscipline of gesture, rare taste water, now as remove pathogenesis in time, can stop the development of pressure ulcer.If continue development, damaged skin is aubergine, and subcutaneous have scleroma, hydroderma, forms blister, forms wound surface, ulcer after diabrosis.If infect towards periphery and deep expansion, then bursting, it is smelly thin to come to a head, or as powder slurry sewage, muscle of with the passing of time often causing injury damages bone, slough blackout, and oxious gas smokes people, often accompanies lethargy, god declines that body is tired, anorexia etc., and prognosis is poor.China is according to the evolution of pressure ulcer, light and heavy degree is different, often be divided into the fourth phases such as congestion ruddy phase, inflammatory infiltration phase, either shallow ulcerative stage, downright bad ulcerative stage, the treatment for the pressure ulcer of either shallow ulcerative stage should promote the formation of granulation tissue while debridement treatment, Promotive union.

At present, treatment pressure ulcer is without good method, and what have pastes lid by ulcer; Also with behind 1:5000 furacilin solution cleaning skin ulcer face, then can wrap up with sterile vaseline gauze and dressing, cleaning in 1-2 days and more change dressings are once; Also be coated with silver sulfadiazine treatment behind normal buffered saline cleaning skin ulcer face; What also have has just used the external application of fresh hen egg Intradermal film at the beginning in pressure ulcer, and every day is changed once.But due to the bactericidal antiphlogistic of medicine, promoting tissue regeneration and ulcer healing, ventilative, drainage effect is bad, and therapeutic effect is all undesirable.

Gel, as a kind of medicine novel dosage forms, is applicable to skin, mucosa, cavity/canal drug administration, not only can avoid oral first pass effect, can also alleviate the toxic and side effects of medicine, be favourably welcome in recent years.Gel means the semisolid with gel characteristic that extract and proper amount of matrix are made or glop.Gel has slow releasing function to drug release, the simple and appearance looks elegant of preparation technology, and being easy to coating uses, and has the features such as easy absorption, not pollution clothes, stability is better after topical.

Summary of the invention

Inventor, on the basis that ancient Chinese medicine doctor tcm characteristic is treated, based on Chinese medicinal formulae, in conjunction with the new dressing of modern repair in trauma and Modern preparations technique, constantly accepts the inspection put into practice, proposes a kind of Chinese medicine gel for the treatment of the pressure ulcer of either shallow ulcerative stage.

The technical solution used in the present invention is:

A kind of Chinese medicine gel for the treatment of the pressure ulcer of either shallow ulcerative stage, comprise the clear paste of 43-55 parts by weight and the gel-type vehicle of 253 ~ 270 parts by weight, described clear paste is made up of following raw material: Ramulus Mori, Ilex purpurea Hassk.[I.chinensis Sims, wear stone rattan, Herba speranskiae tuberculatae, Semen Phaseoli, Serissa foetida, cartilage Cortex Ampelopsis Aconitifoliae Radicis, Radix et Rhizoma Thalictri;

Described gel-type vehicle is made up of the component of following parts by weight: the ethanol 35 ~ 40 parts of carbomer (940) 35 ~ 50 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 5-8 part, glycerol 100-200 part, antiseptic ethyl hydroxybenzoate 7 ~ 12 parts, penetrating agent azone 3 ~ 8 parts, 93 ~ 95% (v/v) and purified water 300 ~ 500 parts.

Acritamer 940, be cross-linked with acrylic acid the acrylic acid crosslinked resin obtained with tetramethylolmethane etc., carbomer is present in water with acid form, and in water and polar organic solvent, (as ethanol, glycerol etc.) is easily swelling.It contains the crosslinked acrylate copolymer of polyalkenyl polyether, containing 56%-68% hydroxy-acid group in molecule, makes these resins be faintly acid, although be weaker than acetic acid, is easy to react with inorganic base and organic bases generate salt.It is owing to having swellability and faintly acid, and be a very important rheology control agent, the carbomer after neutralization is outstanding gel-type vehicle, has the critical nature such as thickening, suspension.

Acrylic Acid Sodium Acrylate-acrylamide copolymer: a kind of new functional macromolecule material, there is the high absorbent function of absorptance from heavy sensation of the body hundred times, and there is high rate of liquid aspiration and high liquid-keeping property, become hydrogel once imbibition, even if pressurization is also difficult to water to separate.

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: Ramulus Mori 8-18 part, Ilex purpurea Hassk.[I.chinensis Sims 20-40 part, wear stone rattan 5-15 part, Herba speranskiae tuberculatae 10-30 part, Semen Phaseoli 6-15 part, Serissa foetida 6-20 part, cartilage Cortex Ampelopsis Aconitifoliae Radicis 5-15 part, Radix et Rhizoma Thalictri 5-25 part.

Further preferably, described clear paste is processed by the crude drug of following weight parts and is prepared from: Ramulus Mori 10-14 part, Ilex purpurea Hassk.[I.chinensis Sims 26-34 part, wear stone rattan 9-13 part, Herba speranskiae tuberculatae 15-20 part, Semen Phaseoli 11-15 part, Serissa foetida 12-17 part, cartilage Cortex Ampelopsis Aconitifoliae Radicis 8-13 part, Radix et Rhizoma Thalictri 9-13 part.

Further preferably, described clear paste is processed by the crude drug of following weight parts and is prepared from: Ramulus Mori 11 parts, Ilex purpurea Hassk.[I.chinensis Sims 28 parts, wear 10 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 12 parts, Semen Phaseoli, Serissa foetida 15 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 12 parts.

Prescription analysis: the pungent temperature of Herba speranskiae tuberculatae, kind dissipating blood stasis for subsidence of swelling, relaxing muscles and tendons to promote blood circulation, expelling wind and removing dampness, removing toxic substances pain relieving, Ilex purpurea Hassk.[I.chinensis Sims merit is apt to heat-clearing and toxic substances removing, promoting tissue regeneration and ulcer healing, promoting blood circulation and hemostasis, two medicines need compatibility mutually, complete function, heat-clearing and toxic substances removing, inducing diuresis to remove edema, expelling the stasis for the new power are strong, for controlling the key medicine of either shallow ulcerative stage pressure ulcer.Wear stone rattan dispelling wind and removing obstruction in the collateral, promoting blood circulation and stopping pain; Semen Phaseoli vital energy regualting and blood circulation-promoting, heat-clearing and toxic substances removing; Cartilage Cortex Ampelopsis Aconitifoliae Radicis clearing away heat and promoting diuresis, dredge the meridian passage are ministerial drug, to strengthen effect of monarch drug altogether.Serissa foetida energy dispelling wind to relieve the exterior syndrome, clearing away heat-damp and promoting diuresis, relaxing muscles and tendons and activating QI and blood in the collateral; Radix et Rhizoma Thalictri heat clearing and damp drying, eliminating fire and detoxication; The capable water of Ramulus Mori expelling wind and removing dampness, dredging collateral is adjuvant drug, expel wind to dredge collateral, and the interior evil poison of inducing diuresis and reducing edema, quickening body is discharged.The application of all medicine associating compatibilities, has heat-clearing and toxic substances removing, the effect of inducing diuresis to remove edema, expelling the stasis for the new, to improve microcirculation around wound surface, increases regional flow, the edema that reduces inflammation and local organization ischemia, anoxia, minimizing inflammatory exudation, promote absorption and the dissipation of inflammation.

In order to increase the chemiluminescence between each raw material, the gel obtained reaches better effect, as homogeneous exquisiteness, easily coating after launching, the strong adhesion skin again of tack, holdup time grows again not skin tightening, be easy to absorb transudate, good stability etc., preferably, described gel-type vehicle is made up of the component of following parts by weight: carbomer (940) 37 ~ 43 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 5-8 part, glycerol 170 ~ 190 parts, antiseptic ethyl hydroxybenzoate 7 ~ 9 parts, penetrating agent azone 4 ~ 6 parts, the ethanol 35 ~ 40 parts of 93 ~ 95% (v/v) and purified water 360 ~ 450 parts.

Preferably, the relative molecular mass of Acrylic Acid Sodium Acrylate-acrylamide copolymer used is 1,000 ten thousand ~ 1,200 ten thousand.

In side, the pharmacological property of each taste medicinal raw material is as follows:

Ramulus Mori: bitter; Property is put down.Return Liver Channel.Function cures mainly: wind-damp dispelling; The meridian dredging; Row aqueous vapor.Main air pain of dampness syndrome; Apoplexy and hemiplegia; Edema foot gas; Human body pruritus due to wind pathogen.

Ilex purpurea Hassk.[I.chinensis Sims: bitter; Puckery; Cool.Function cures mainly: heat-clearing and toxic substances removing; Promoting tissue regeneration and ulcer healing; Promoting blood circulation and hemostasis.Main cough due to lung-heat; Laryngopharynx swelling and pain; Dysentery; Diarrhoea; Biliary tract infection; Urinary tract infection; Angina pectoris; Burn and scald; Pyretic toxicity carbuncle; Ulcer of the lower limb; Leprelcosis; Eczema; Chilblain; Chap; Thromboangiitis obliterans; Traumatic hemorrhage.Modern pharmacological research shows, it has antibacterial, antiinflammation, as: its dilute aqueous solution all has inhibitory action to bacillus pyocyaneus, escherichia coli, Bacillus typhi, shigella flexneri, Bacillus alcaligenes, bacillus subtilis, staphylococcus aureus.Its antimicrobial component is mainly protocatechuic acid, to escherichia coli, bacillus pyocyaneus, Bacillus proteus and staphylococcus aureus 4 whole inhibitory action of strain, also may contain other antibiotic effective ingredients.

Wear stone rattan: bitter; Pungent; Temperature.Return liver; Stomach; Large intestine channel.Function cures mainly: dispelling wind and removing obstruction in the collateral; Promoting blood circulation and stopping pain.Main air pain of dampness syndrome; Stomachache; Traumatic injury pain caused by ecchymoma; Intestinal is scorching; Poliomyelitis sequela.

Herba speranskiae tuberculatae: pungent; Warm in nature.Return lung; Liver Channel.Function cures mainly: expelling wind and removing dampness; Relaxing muscles and tendons to promote blood circulation; Dissipating blood stasis for subsidence of swelling; Removing toxic substances pain relieving.Main air pain of dampness syndrome; Muscles and bones contracture; The disturbance of lower legs due to pathogenic cold and dampness; Lumbar strain; Paralysis; Amenorrhea; Eczema scrotum; Furuncle toxic swelling.

Semen Phaseoli: bitter; Property is put down; Mild toxicity.Return liver; Spleen channel.Function cures mainly: vital energy regualting and blood circulation-promoting; Heat-clearing and toxic substances removing.Main heart peratodynia; Hernia pain; Amenorrhea due to stagnation of blood; Innominate toxic swelling; Furuncle.

Serissa foetida: light, micro-pungent, cool.Function cures mainly: dispelling wind to relieve the exterior syndrome, clearing away heat-damp and promoting diuresis, relaxing muscles and tendons and activating QI and blood in the collateral.For flu, cough, toothache, acute tonsillitis, pharyngolaryngitis, acute hepatitis, chronic hepatitis, enteritis, dysentery, infantile malnutrition, hypertension complicated headache, migraine, rheumatic arthralgia, leucorrhea; Stem ashing eye dripping controls mist.

Cartilage Cortex Ampelopsis Aconitifoliae Radicis: bitter, acrid, cold.Function cures mainly: clearing away heat and promoting diuresis, dredge the meridian passage.Cure mainly edema, galactostasis, rheumatic ostalgia.Skin ulcer pain furuncle and phyma is controlled in external.

Radix et Rhizoma Thalictri: nature and flavor bitter cold, heat clearing and damp drying, eliminating fire and detoxication.Control damp-heat dysentery, jaundice, calentura is irritated, cough due to lung-heat, carbuncle pyogenic infections from tumour or sore, conjunctival congestion and swelling pain.Be applied to enteritis now, infectious hepatitis, flu, measles, carbuncle furuncle, conjunctivitis.

The invention also discloses a kind of preparation method for the treatment of the Chinese medicine gel of either shallow ulcerative stage pressure ulcer.

A kind of preparation method for the treatment of the Chinese medicine gel of either shallow ulcerative stage pressure ulcer disclosed by the invention, comprises the following steps:

1) by Ramulus Mori, Ilex purpurea Hassk.[I.chinensis Sims, wear stone rattan, Herba speranskiae tuberculatae, Semen Phaseoli, Serissa foetida, cartilage Cortex Ampelopsis Aconitifoliae Radicis, Radix et Rhizoma Thalictri 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, filter; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.05 ~ 1.10 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 ~ 1.25 (60 DEG C record), obtains described clear paste;

2) carbomer (940) is added in purified water, fully swelling; Add glycerol, Chinese medicine clear paste, penetrating agent azone successively, mix homogeneously;

3) antiseptic ethyl hydroxybenzoate is dissolved in the ethanol of 93 ~ 95% (v/v), adds 2) mixed liquor in, mixing, then add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain gel.

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 260-300g.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 (2,4-dinitro-chloro-benzene 1% 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) Chinese medicine gel of the present invention is tested the observation of curative effect of either shallow ulcerative stage pressure ulcer

1 data and method

1.1 physical data: select my institute either shallow ulcerative stage Patients with Pressure Ulcers 84 example that in January, 2014, in December ,-2014 was accepted for medical treatment, diagnosis, with reference to " Fundamental Nursing " (Zhou Gengsu, publishing house of The Fourth Military Medical University, 2009), is divided into matched group and treatment group at random.Matched group: male 26 example, women 16 example; 56 ~ 84 years old age, the median age (67.4 ± 5.63) year; Pressure ulcer time of origin 4 weeks ~ 3 months, average (1.26 ± 0.47) individual month; Treatment group: male 27 example, women 15 example; 57 ~ 85 years old age, the median age (68.1 ± 5.92) year; Pressure ulcer time of origin 5 weeks ~ 3.5 months, average (1.32 ± 0.48) individual month; The physical data contrast difference not statistically significant (P > 0.05) such as sex, age, pressure ulcer time of origin of two groups of patients, has comparability.

1.2 Therapeutic Method:

Matched group: the slough thoroughly removing skin ulcer face with aseptic nipper and shears, with hydrogen peroxide sterilization, then cleans skin ulcer face with povidone iodine and normal saline flushing, Mupirocin Ointment ointment is applied in pressure ulcer wound surface, then cover with sterile gauze, change dressings every day 2 times;

Treatment group: on above-mentioned debridement treatment basis, be spread evenly across wound surface with Chinese medicine film-forming gel agent prepared by the embodiment of the present invention 1, change dressings every day 2 times.

Two groups of treatments, 3 weeks rear observe the curative effect.

1.3 care methods: the air circulation strengthening ward, timing carries out effective cleaning and disinfection to the article such as sheet, quilt, ensures good hospital environment, suppresses the breeding of pathogen in air; Timing turning over changes position, and avoid pressure ulcer wound surface to be oppressed for a long time, air fluidized bed and turning over pillow can be used to assist, and patient skin often produces strong scratchiness, the generation of the destruction of skin prevention healing wound surface of should avoiding scratching and again subinfection; Medical worker should fully understand the health of patient, conservative control diet, suggestion patient increases is rich in high protein, low fat and homovitamin group food, improve the nutriture of patient, improve patient body resistance, promote the quickly-healing of wound surface, avoid the food of the edible property sent out and too pungent stimulation; Pay close attention to the mental change of patient at any time, give psychological instruction, the fear eliminating patient and anxiety in time, strengthen the confidence of Rehabilitation, make its positive partner treatment.

1.4 efficacy assessment standards: promulgate " Chinese medical disease Standardization of diagnosis and curative effect " with reference to State Administration of Traditional Chinese Medicine.Recovery from illness: heal completely in skin ulcer face; Effective: wound surface is dry, and skin ulcer reduction of area is little reaches more than 70%; Take a turn for the better: inflammatory exudate reduces, and skin ulcer reduction of area is little by more than 30%; Invalid: inflammatory exudate does not reduce, skin ulcer reduction of area little less than 30% or skin ulcer face expand.Effective percentage=(recovery from illness+effective)/total number of cases × 100%.

1.5 statistical procedures application SPSS16.0 statistical softwares.Measurement data with represent, and t inspection is adopted to data.P < 0.05 has statistical significance for difference.

2 results

After 2.1 liang of group treatments, effective percentage compares: treatment group effective percentage is 90.5%, and matched group effective percentage is 61.9%, two groups and compares, and difference has statistical significance (P < 0.05).In table 1.

Table 1: after two groups of treatments, effective percentage compares, example (%)

Compare with matched group, * P < 0.05.

After 2.2 liang of group treatments, wound surface area change compares: before after result shows two groups of treatments, wound surface area is all less than treatment, difference has statistical significance (P < 0.05), after treatment, treatment group wound surface area is all less than matched group, and difference has statistical significance (P < 0.05).In table 2.

Table 2: after two groups of treatments, wound surface area change compares

With ratio before treatment, ^#p < 0.05; Matched group compares, * P < 0.05.

Find according to clinical observation, this Chinese medicine gel not only good absorbing, penetrance is strong, and quick result, and after general medication, 2-3 skin lesion place erythema just has and alleviate sign, and treatment group transudate is obviously less than matched group.In addition, continuous use 3 weeks in all patients, be showed no obvious toxic and side effects and pessimal stimulation, safety is higher.

The therapeutic effect of Chinese medicine gel of the present invention is better in sum, can not cause skin allergy, to the complete and equal non-toxic reaction of damaged skin, and good stability, the holding time is long.

In a word, the present invention has following beneficial effect:

The all medicine compatibilities of Chinese medicine preparation of the present invention play heat-clearing and toxic substances removing, effect of inducing diuresis to remove edema, expelling the stasis for the new altogether, through zoology test and clinical verification, and Chinese medicine gel excellent effect of the present invention.

Inventive gel agent matrix flow is suitable for, be easy to the exhibition that is coated with, good with skin affinity, good with the compatibility of Chinese medicine clear paste, slowly steadily can discharge medicine, be conducive to improving the bioavailability of medicine.

Inventive gel agent, to skin and mucosa nonirritant, can not cause skin allergy, use safety, not pollution clothes.

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.

Embodiment 1

The consumption of Acrylic Acid Sodium Acrylate-acrylamide copolymer is on the impact of gel

Prescription: the gel-type vehicle of 47 weight portion clear paste and 260 parts by weight

Clear paste raw material is made (weight portion): Ramulus Mori 11 parts, Ilex purpurea Hassk.[I.chinensis Sims 28 parts, wear 10 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 12 parts, Semen Phaseoli, Serissa foetida 15 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 12 parts.

Clear paste preparation method: by Ramulus Mori, Ilex purpurea Hassk.[I.chinensis Sims, wear stone rattan, Herba speranskiae tuberculatae, Semen Phaseoli, Serissa foetida, cartilage Cortex Ampelopsis Aconitifoliae Radicis, Radix et Rhizoma Thalictri 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 ~ 1.10 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 ~ 1.25 (60 DEG C record), obtains described clear paste;

Gel preparation method: carbomer (940) is added in purified water, fully swelling; Add glycerol, Chinese medicine clear paste, penetrating agent azone successively, mix homogeneously; Antiseptic ethyl hydroxybenzoate is dissolved in the ethanol of 93 ~ 95% (v/v), adds in the mixed liquor of above-mentioned gained, mixing, then adds Acrylic Acid Sodium Acrylate-acrylamide copolymer, is stirred to and is uniformly dispersed, obtain gel.

Acrylic Acid Sodium Acrylate-acrylamide copolymer has the high absorbent function of absorptance from heavy sensation of the body hundred times, for investigating the impact of its consumption on gel, substrate composition is preferred: carbomer (940) 40 parts, glycerol 180 parts, antiseptic ethyl hydroxybenzoate 8 parts, penetrating agent azone 5 parts, the ethanol 35 parts of 93% (v/v) and purified water 400 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer elects 1 part respectively as, 3 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 11 parts, gel substrate is made according to formula ratio, Chinese medicine clear paste is added in substrate, stirring makes to be uniformly dispersed, make gel formulations.From the viscous sense of preparation, carry aqueous, stretchability, three indexs investigate Acrylic Acid Sodium Acrylate-acrylamide copolymers to the impact of the quality of the pharmaceutical preparations.The results are shown in Table 3.

Table 3: Acrylic Acid Sodium Acrylate-acrylamide copolymer is on the impact of gel formulations

Viscous sense classification: strong, general, nothing; Water carrying capacity ascending point 1,2,3,4 grade; Stretchability classification: strong, general, poor.

Embodiment 2

Prescription: the gel-type vehicle of 50 weight portion clear paste and 260 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 11 parts, Ilex purpurea Hassk.[I.chinensis Sims 28 parts, wear 10 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 12 parts, Semen Phaseoli, Serissa foetida 15 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 12 parts;

Gel-type vehicle (weight portion): the ethanol 35 parts of carbomer (940) 40 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 6 parts, glycerol 178 parts, antiseptic ethyl hydroxybenzoate 7 parts, penetrating agent azone 4 parts, 95% (v/v) and purified water 410 parts.

Preparation method: by Ramulus Mori, Ilex purpurea Hassk.[I.chinensis Sims, wear stone rattan, Herba speranskiae tuberculatae, Semen Phaseoli, Serissa foetida, cartilage Cortex Ampelopsis Aconitifoliae Radicis, Radix et Rhizoma Thalictri 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 ~ 1.10 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 ~ 1.25 (60 DEG C record), obtains described clear paste;

2) carbomer (940) is added in purified water, fully swelling; Add glycerol, Chinese medicine clear paste, penetrating agent azone successively, mix homogeneously;

3) antiseptic ethyl hydroxybenzoate is dissolved in the ethanol of 95% (v/v), adds 2) mixed liquor in, mixing, then add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain gel.

Embodiment 3

Prescription: the gel-type vehicle of 47 weight portion clear paste and 262 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 12 parts, Ilex purpurea Hassk.[I.chinensis Sims 30 parts, wear 12 parts, stone rattan, Herba speranskiae tuberculatae 20 parts, 11 parts, Semen Phaseoli, Serissa foetida 12 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 12 parts, Radix et Rhizoma Thalictri 10 parts;

Gel-type vehicle (weight portion): the ethanol 36 parts of carbomer (940) 37 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 7 parts, glycerol 174 parts, antiseptic ethyl hydroxybenzoate 7 parts, penetrating agent azone 5 parts, 95% (v/v) and purified water 390 parts.

Preparation method: carry out with reference to embodiment 1-2.

Embodiment 4

Prescription: the gel-type vehicle of 53 weight portion clear paste and 268 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 10 parts, Ilex purpurea Hassk.[I.chinensis Sims 34 parts, wear 12 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 15 parts, Semen Phaseoli, Serissa foetida 17 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 12 parts;

The ethanol 37 parts of gel-type vehicle (weight portion) carbomer (940) 40 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 7 parts, glycerol 185 parts, antiseptic ethyl hydroxybenzoate 8 parts, penetrating agent azone 5 parts, 94% (v/v) and purified water 420 parts.

Preparation method: carry out with reference to embodiment 1-2.

Embodiment 5

Prescription: the gel-type vehicle of 50 weight portion clear paste and 260 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 14 parts, Ilex purpurea Hassk.[I.chinensis Sims 28 parts, wear 12 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 14 parts, Semen Phaseoli, Serissa foetida 17 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 9 parts;

The ethanol 36 parts of gel-type vehicle (weight portion) carbomer (940) 42 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 8 parts, glycerol 190 parts, antiseptic ethyl hydroxybenzoate 9 parts, penetrating agent azone 4 parts, 94% (v/v) and purified water 440 parts.

Preparation method: carry out with reference to embodiment 1-2.

Embodiment 6

Prescription: the gel-type vehicle of 45 weight portion clear paste and 260 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 10 parts, Ilex purpurea Hassk.[I.chinensis Sims 30 parts, wear 10 parts, stone rattan, Herba speranskiae tuberculatae 20 parts, 15 parts, Semen Phaseoli, Serissa foetida 18 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 15 parts, Radix et Rhizoma Thalictri 15 parts;

Gel-type vehicle (weight portion): the ethanol 40 parts of carbomer (940) 42 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 6 parts, glycerol 178 parts, antiseptic ethyl hydroxybenzoate 7 parts, penetrating agent azone 4 parts, 93% (v/v) and purified water 420 parts.

Preparation method: carry out with reference to embodiment 1-2.

Embodiment 7

Prescription: the gel-type vehicle of 50 weight portion clear paste and 260 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 12 parts, Ilex purpurea Hassk.[I.chinensis Sims 29 parts, wear 12 parts, stone rattan, Herba speranskiae tuberculatae 20 parts, 15 parts, Semen Phaseoli, Serissa foetida 20 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 12 parts, Radix et Rhizoma Thalictri 20 parts;

Gel-type vehicle (weight portion): the ethanol 37 parts of carbomer (940) 40 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 6 parts, glycerol 180 parts, antiseptic ethyl hydroxybenzoate 8 parts, penetrating agent azone 5 parts, 94% (v/v) and purified water 390 parts.

Preparation method: carry out with reference to embodiment 1-2.

Embodiment 8

Prescription: the gel-type vehicle of 47 weight portion clear paste and 265 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 11 parts, Ilex purpurea Hassk.[I.chinensis Sims 28 parts, wear 10 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 12 parts, Semen Phaseoli, Serissa foetida 15 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 12 parts;

Gel-type vehicle (weight portion): the ethanol 38 parts of carbomer (940) 43 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 8 parts, glycerol 190 parts, antiseptic ethyl hydroxybenzoate 7 parts, penetrating agent azone 4 parts, 93% (v/v) and purified water 450 parts.

Preparation method: carry out with reference to embodiment 1-2.

Embodiment 9

Prescription: the gel-type vehicle of 50 weight portion clear paste and 260 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 15 parts, Ilex purpurea Hassk.[I.chinensis Sims 35 parts, wear 10 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 15 parts, Semen Phaseoli, Serissa foetida 20 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 12 parts;

Gel-type vehicle (weight portion): the ethanol 37 parts of carbomer (940) 40 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 6 parts, glycerol 185 parts, antiseptic ethyl hydroxybenzoate 7 parts, penetrating agent azone 6 parts, 94% (v/v) and purified water 420 parts.

Preparation method: carry out with reference to embodiment 1-2.

Embodiment 10

Prescription: the gel-type vehicle of 48 weight portion clear paste and 258 parts by weight;

Clear paste raw material is made (weight portion): Ramulus Mori 12 parts, Ilex purpurea Hassk.[I.chinensis Sims 34 parts, wear 12 parts, stone rattan, Herba speranskiae tuberculatae 18 parts, 12 parts, Semen Phaseoli, Serissa foetida 15 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 12 parts, Radix et Rhizoma Thalictri 12 parts;

Gel-type vehicle (weight portion): the ethanol 37 parts of carbomer (940) 38 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 5 parts, glycerol 170 parts, antiseptic ethyl hydroxybenzoate 7 parts, penetrating agent azone 4 parts, 93% (v/v) and purified water 400 parts.

Preparation method: carry out with reference to embodiment 1-2.

Claims (7)

1. treat the Chinese medicine gel of either shallow ulcerative stage pressure ulcer for one kind, it is characterized in that comprising the clear paste of 43-55 parts by weight and the gel-type vehicle of 253 ~ 270 parts by weight, described clear paste is made up of following raw material: Ramulus Mori, Ilex purpurea Hassk.[I.chinensis Sims, wear stone rattan, Herba speranskiae tuberculatae, Semen Phaseoli, Serissa foetida, cartilage Cortex Ampelopsis Aconitifoliae Radicis, Radix et Rhizoma Thalictri;

Described gel-type vehicle is made up of the component of following parts by weight: the ethanol 35 ~ 40 parts of carbomer (940) 35 ~ 50 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 5-8 part, glycerol 100-200 part, antiseptic ethyl hydroxybenzoate 7 ~ 12 parts, penetrating agent azone 3 ~ 8 parts, 93 ~ 95% (v/v) and purified water 300 ~ 500 parts.

2. Chinese medicine gel as claimed in claim 1, is characterized in that clear paste is processed by the crude drug of following preferred weight part and is prepared from: Ramulus Mori 8-18 part, Ilex purpurea Hassk.[I.chinensis Sims 20-40 part, wear stone rattan 5-15 part, Herba speranskiae tuberculatae 10-30 part, Semen Phaseoli 6-15 part, Serissa foetida 6-20 part, cartilage Cortex Ampelopsis Aconitifoliae Radicis 5-15 part, Radix et Rhizoma Thalictri 5-25 part.

3. Chinese medicine gel as claimed in claim 2, is characterized in that clear paste is processed by the crude drug of following preferred weight part and is prepared from: Ramulus Mori 10-14 part, Ilex purpurea Hassk.[I.chinensis Sims 26-34 part, wear stone rattan 9-13 part, Herba speranskiae tuberculatae 15-20 part, Semen Phaseoli 11-15 part, Serissa foetida 12-17 part, cartilage Cortex Ampelopsis Aconitifoliae Radicis 8-13 part, Radix et Rhizoma Thalictri 9-13 part.

4. Chinese medicine gel as claimed in claim 3, is characterized in that clear paste is processed by the crude drug of following preferred weight part and is prepared from: Ramulus Mori 11 parts, Ilex purpurea Hassk.[I.chinensis Sims 28 parts, wear 10 parts, stone rattan, Herba speranskiae tuberculatae 15 parts, 12 parts, Semen Phaseoli, Serissa foetida 15 parts, cartilage Cortex Ampelopsis Aconitifoliae Radicis 10 parts, Radix et Rhizoma Thalictri 12 parts.

5. the Chinese medicine gel as described in claim 1-4, is characterized in that described gel-type vehicle is made up of the component of following preferred weight number: the ethanol 35 ~ 40 parts of carbomer (940) 37 ~ 43 parts, Acrylic Acid Sodium Acrylate-acrylamide copolymer 5-8 part, glycerol 170 ~ 190 parts, ethyl hydroxybenzoate 7 ~ 9 parts, azone 4 ~ 6 parts, 93 ~ 95% (v/v) and purified water 360 ~ 450 parts.

6. the Chinese medicine gel as described in claim 1-5, is characterized in that the relative molecular mass of described Acrylic Acid Sodium Acrylate-acrylamide copolymer is 1,000 ten thousand ~ 12,000,000.

7. the Chinese medicine gel as described in claim 1-6, is characterized in that its preparation method comprises the following steps:

1) by Ramulus Mori, Ilex purpurea Hassk.[I.chinensis Sims, wear stone rattan, Herba speranskiae tuberculatae, Semen Phaseoli, Serissa foetida, cartilage Cortex Ampelopsis Aconitifoliae Radicis, Radix et Rhizoma Thalictri 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, filter; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.05 ~ 1.10 (60 DEG C record), adds ethanol and makes the volumn concentration of ethanol reach 60% ~ 70%, and after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 ~ 1.25 (60 DEG C record), obtains described clear paste;

2) carbomer (940) is added in purified water, fully swelling; Add glycerol, Chinese medicine clear paste, azone successively, mix homogeneously;

3) ethyl hydroxybenzoate is dissolved in the ethanol of 93 ~ 95% (v/v), adds 2) mixed liquor in, mixing, then add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain gel.