CN105477272B

CN105477272B - Marine organism wound-protecting film spraying agent

Info

Publication number: CN105477272B
Application number: CN201510910535.7A
Authority: CN
Inventors: 焦念强; 焦坤
Original assignee: Tianjin Baima Biological Technology Engineering Co Ltd
Current assignee: Tianjin Baima Biological Technology Engineering Co Ltd
Priority date: 2015-12-10
Filing date: 2015-12-10
Publication date: 2019-12-27
Anticipated expiration: 2035-12-10
Also published as: CN105477272A

Abstract

The invention discloses a marine organism wound-protecting film spraying agent, and belongs to the technical field of traditional Chinese medicines. The marine organism wound-protecting film spraying agent is prepared from the following raw materials: chitosan, chitosan oligosaccharide, lactic acid, aloe water extract, astragalus root, dahurian angelica root, catechu and honeysuckle flower. Compared with the prior art, the film spraying agent has stronger sterilization and anti-infection capability, wider application and wider application range, and has stronger capability of promoting the growth and repair of the wound surface, shortening the healing time, eliminating the pigmentation around the wound surface and inhibiting the formation of scars.

Description

Marine organism wound-protecting film spraying agent

Technical Field

The invention relates to a traditional Chinese medicine composition for healing skin wounds, in particular to a marine organism wound-protecting film spraying agent, and belongs to the technical field of traditional Chinese medicines.

Background

The skin is the largest organ of the human body, and is wrapped on the whole surface of the human body and connected with the mucous epithelium of the external orifice of the digestive, respiratory, urinary and reproductive systems, thereby forming the most ideal coat for the human body, protecting the internal organs and preventing the invasion of various external factors.

But because it is the outermost layer of the human body, the phenomenon that people suffer from bite, extrusion, friction, crash and the like in daily life is difficult to avoid. Wounds such as cut, scratch, blood stasis, crush, scratch, laceration, puncture, mosquito bite, burn and scald and wounds such as bedsore and operation wounds in hospitals usually occur, and after the wounds occur, the wounds need to be treated in time, otherwise pyogenic infection can occur due to invasion of pathogenic bacteria, local red, swelling, heat, pain and dysfunction can also occur, and in severe cases, diseases such as toxemia, septicemia and tetanus can be caused due to the fact that bacteria and toxins enter blood circulation, and very serious consequences can be caused.

The invention discloses a Chinese invention patent, patent number 201210178375.8, a composition for healing trauma and a film spraying agent thereof, wherein the film spraying agent comprises the following components in percentage by mass by volume: 0.5 to 4 percent of chitosan, 0.5 to 3 percent of chitosan oligosaccharide, 0.5 to 5 percent of lactic acid, 3 to 10 percent of aloe water extract and the balance of water. The composition has effects of stopping bleeding and relieving pain, activating cell, repairing damaged cell, promoting tissue repair and regeneration, promoting wound healing, and has good compatibility with skin without scar.

Disclosure of Invention

The invention aims to solve the technical problem of developing a novel traditional Chinese medicine composition based on the prior art, and the novel traditional Chinese medicine composition is suitable for being prepared into a film spraying agent, so that the curative rate of the novel traditional Chinese medicine composition on various wounds of the skin is higher, the healed scars are slight, and the application range is wider.

In order to solve the technical problem, the inventor provides a novel traditional Chinese medicine composition by taking the prior art as the basis and combining the traditional medical experience and theory of China to carry out repeated zoology experiments.

The invention is realized by the following technical scheme:

a marine organism wound-protecting film spraying agent is prepared from the following raw materials: chitosan, chitosan oligosaccharide, lactic acid, aloe water extract, astragalus root, dahurian angelica root, catechu and honeysuckle flower.

Preferably, the marine organism wound-protecting film spraying agent is prepared from the following raw materials in parts by weight: 1-12 parts of chitosan, 1-12 parts of chitosan oligosaccharide, 1-12 parts of lactic acid, 1-16 parts of aloe water extract, 1-12 parts of astragalus membranaceus, 1-12 parts of radix angelicae, 1-12 parts of catechu and 1-12 parts of honeysuckle.

Preferably, the marine organism wound-protecting film spraying agent is prepared from the following raw materials in parts by weight: 3-8 parts of chitosan, 2-6 parts of chitosan oligosaccharide, 2-8 parts of lactic acid, 2-6 parts of aloe water extract, 3-6 parts of astragalus membranaceus, 3-6 parts of radix angelicae, 6-12 parts of catechu and 2-8 parts of honeysuckle.

Preferably, the marine organism wound-protecting film spraying agent is prepared from the following raw materials in parts by weight: 6 parts of chitosan, 4 parts of chitosan oligosaccharide, 4 parts of lactic acid, 4 parts of aloe water extract, 4 parts of astragalus membranaceus, 4 parts of radix angelicae, 8 parts of catechu and 4 parts of honeysuckle.

Preferably, the marine organism wound-protecting film spraying agent is prepared from the following raw materials in parts by weight: 8 parts of chitosan, 4 parts of chitosan oligosaccharide, 8 parts of lactic acid, 6 parts of aloe water extract, 6 parts of astragalus membranaceus, 6 parts of radix angelicae, 8 parts of catechu and 8 parts of honeysuckle.

Preferably, the marine organism wound-protecting film spraying agent is prepared from the following raw materials in parts by weight: 6 parts of chitosan, 6 parts of chitosan oligosaccharide, 3 parts of lactic acid, 3 parts of aloe water extract, 3 parts of astragalus membranaceus, 3 parts of radix angelicae, 6 parts of catechu and 3 parts of honeysuckle.

A method for preparing the marine organism wound-protecting film spraying agent comprises the following steps:

1) respectively weighing chitosan, chitosan oligosaccharide, lactic acid, aloe water extract, astragalus, angelica dahurica, catechu and honeysuckle according to the weight part ratio;

2) pulverizing radix astragali, radix Angelicae Dahuricae, Catechu, and flos Lonicerae, mixing, adding purified water 6-12 times the weight of radix astragali, radix Angelicae Dahuricae, Catechu, and flos Lonicerae, soaking for 6-24 hr, decocting under reflux for 1-2 hr, and filtering to obtain filtrate; adding 4-8 times of purified water, decocting under reflux for 1-2 hr, filtering, mixing filtrates, and concentrating to 1/3-1/2 to obtain Chinese medicinal concentrated solution;

3) adding Aloe powder into purified water, heating to 60 + -2 deg.C, stirring, extracting for 2-3 hr, filtering, concentrating the filtrate, and drying to obtain Aloe water extract;

4) adding chitosan, chitosan oligosaccharide, lactic acid and the aloe water extract obtained in the step 3) into the Chinese medicinal concentrated solution obtained in the step 2), and stirring until the chitosan, the chitosan oligosaccharide and the aloe water extract are completely dissolved to obtain a mixed solution;

5) concentrating the mixed solution obtained in the step 4), then filling the concentrated mixed solution into a spray bottle, installing a bottle cap, and sterilizing by cobalt-60 irradiation to obtain the film spraying agent.

In the invention: the chitosan and the chitosan oligosaccharide are derivatives of chitin, especially the macromolecular chitosan has obvious film forming property, and the film has good air permeability and waterproof permeability and can absorb liquid secreted by a wound surface. Has the function of killing pathogenic bacteria such as staphylococcus, streptococcus, escherichia coli and the like which cause infection, so that the infection can be prevented and prevented; has hemostatic and analgesic effects; has the functions of activating cells, repairing damaged cells and promoting the repair and regeneration of tissues; can promote the wound to heal quickly, does not produce scars and has good compatibility with the skin.

Aloe active substance: is extracted from aloe, is safe and nontoxic, and the aloe active substance is a natural skin protectant and can provide nutrients for skin; has antibacterial and antiinflammatory effects; has analgesic effect; has moisture keeping effect; can activate cells, repair damaged cells and promote wound healing.

Lactic acid: is an organic acid, and can continuously generate lactic acid in the processes of metabolism and movement of human body, so that the lactic acid is safe and non-toxic. The lactic acid is a chitosan dissolving agent, can dissolve chitosan and enable the chitosan to have positive charges, is a natural moisturizing factor inherent to skin, can be well combined with the skin, improves the wound healing speed, and has a protective effect on the skin.

Astragalus root: sweet in flavor and warm in nature. It enters lung and spleen meridians. Tonify qi, strengthen superficies, induce diuresis, expel pus, heal wound and promote tissue regeneration. In vitro bacteriostasis test of astragalus: it has inhibitory effect on Shigella shigella, Bacillus anthracis, alpha hemolytic streptococcus, beta hemolytic streptococcus, diphtheria bacillus, pseudodiphtheria bacillus, Diplococcus pneumoniae, Staphylococcus aureus, Staphylococcus citreus, Bacillus subtilis, etc.

Radix angelicae: pungent flavor and warm nature. It enters stomach, large intestine and lung meridians. Dispel wind and dampness, induce resuscitation and alleviate pain, resolve swelling and expel pus. Modern pharmacological experiments prove that astragalus membranaceus has the following characteristics: 1. anti-inflammatory action: the mouse gavage angelica dahurica or Hangzhou angelica dahurica decoction (lg is equivalent to the crude drug lg) is 4g/kg, and can obviously inhibit the ear inflammation of the mouse caused by dimethylbenzene (P is less than 0.01). 2. Antipyretic analgesic effect: a hyperpyrexia animal model is caused by subcutaneous injection of peptone to the back of a white rabbit, and 1g of angelica dahurica or 15g/kg of Hangzhou angelica dahurica decoction has an obvious antipyretic effect. The stomach perfusion angelica dahurica or the Hangzhou angelica dahurica decoction of the mouse is 8g/kg, the times of writhing of the mouse caused by injecting 1 percent acetic acid (0.l/kg) into the abdominal cavity are obviously reduced, the action is similar to 8mg/kg of aminopyrine, and P is less than 0.001. In a mouse hot plate test, when the pain threshold is within 30 minutes before administration, 8g/kg of angelica dahurica or radix angelicae dahuricae is applied by stomach irrigation, and 60 minutes after administration, the pain threshold of the angelica dahurica and the anti-angelica dahurica is obviously improved, and compared with a normal saline group, P is less than 0.001 and 0.01. 3. Spasmolysis: the bergapten, xanthotoxin and isoimperatorin B contained in the product have obvious spasmolytic effect on rabbit ileum. Isoimperatorin also increases contractility of rabbit uterus and tonicity of earthworm muscles. Scopoletin has spasmolytic effect on in vivo or in vitro rat uterine spasm caused by estrogen or barium chloride, and its ED50 is 0.09 mg/kg. 4. The antibacterial effect is as follows: the decoction of radix Angelicae Dahuricae has inhibitory effect on Escherichia coli, dysentery bacillus, Bacillus proteus, typhoid bacillus, paratyphoid bacillus, Pseudomonas aeruginosa, Vibrio cholerae, and human type tubercle bacillus. The imperatorin contained in the product has antibacterial effect on 11 strains in vitro; imperatorin also has antibacterial effect and can be used for treating skin ulcer; the MIC for human Mycobacterium tuberculosis H37RV was 100 mc/ml. The water-soaking agent also has a certain inhibiting effect on pathogenic fungi such as Odongqin small spore ringworm fungus and the like.

Catechu: bitter and astringent in nature and slightly cold in nature. It enters lung meridian. Astringe dampness, promote tissue regeneration and heal wound. Can be used for treating unhealed ulcer, eczema, aphtha, traumatic injury, traumatic hemorrhage. Modern pharmacological experiments prove that: the Catechu decoction has inhibitory effect on Staphylococcus aureus, Bacillus diphtheriae, Bacillus proteus, Bacillus dysenteriae and Bacillus typhi; it also has inhibitory effect on common pathogenic dermatophytes. The extract of the leaf has inhibitory effect on Staphylococcus aureus and Escherichia coli.

Honeysuckle flower: sweet in flavor and cold in nature. It enters lung, heart and stomach meridians. Clear heat and remove toxicity, cool and disperse wind-heat. Modern pharmacological experiments prove that the honeysuckle has the following effects: 1. the function of resisting pathogenic microorganisms: in vitro experiments show that the flowers and the vines have certain inhibition effects on various pathogenic bacteria such as staphylococcus aureus, hemolytic streptococcus, escherichia coli, dysentery bacillus, vibrio cholerae, typhoid bacillus, paratyphoid bacillus and the like, and are also effective on pneumococcus, meningococcus, pseudomonas aeruginosa and mycobacterium tuberculosis. The water infusion has stronger action than decoction, and the leaf decoction has stronger action than the flower decoction. If the antibacterial agent is used together with fructus forsythiae, the antibacterial ranges can be complemented; the combination of penicillin and penicillin can enhance the antibacterial effect of penicillin on drug-resistant staphylococcus aureus, which is probably a synergistic effect on inhibiting the protein synthesis in bacteria. Chlorogenic acid and isochlorogenic acid are considered as main antibacterial active ingredients of honeysuckle. Experiments prove that the luteolin also has strong antibacterial effect. The product has different degrees of inhibition effect on dermatophytes such as Microsporum ferrugineum, Nocardia stellatus, etc. The flos Lonicerae decoction (1: 20) has inhibitory effect on influenza virus, orphan virus, and herpes virus in tissue culture of human embryo kidney primordial monolayer epithelial cell. The aqueous solution of rattan also has the function of delaying the cytopathology caused by the orphan virus. Test tube experiments show that decoction of flos Lonicerae and its caulis Lonicerae has inhibitory effect on leptospira. The honeysuckle stem and the groundsel are used for matching and are used for intraperitoneal injection and subcutaneous injection, which is said to have the effects of treating rabbits and preventing uncaria spirochaeta disease. The injection of 7.5g/kg of the honeysuckle injection into the abdominal cavity can ensure that the mice receiving the endotoxin of the pseudomonas aeruginosa of LD90 or the pseudomonas aeruginosa survive more than half. The flos Lonicerae distillate is injected intravenously at a dose of 6g/kg, and can be used for treating rabbit suffering from Pseudomonas aeruginosa endotoxin poisoning. The total number of mild white blood cells of untreated animals is obviously reduced, the phenomenon that the white blood cells have cores moving left is avoided, the body temperature of the animals in the administration group is slightly increased, the white blood cells are increased but the classification is not obviously changed, 7.5g/kg of golden yellow injection (prepared from honeysuckle flower and scutellaria baicalensis in equal amount) is administered by intravenous injection, a certain resisting effect on the endotoxin poisoning of pseudomonas aeruginosa of rabbits is achieved, and the poisoning symptom and death number can be relieved. 2. Anti-inflammatory and antipyretic effects: the injection of flos Lonicerae extract in abdominal cavity is 0.25g/kg, and can inhibit carrageenan foot swelling of rat. In addition, 30-40g/kg of honeysuckle injection is reported to reduce the degree of egg white edema. The injection of the honeysuckle extract solution into the abdominal cavity for 8g/kg for 2 times/day for 6 consecutive days also has obvious anti-exudation and anti-hyperplasia effects on oily meat bud sacs of croton in rats. Honeysuckle is reported to have obvious antipyretic effect in early days, but cholera bacterin, potato bacillus, hay extract and the like are used for intravenous injection of rabbit ears to generate heat, the antipyretic effect of 5g/kg stomach irrigation of honeysuckle decoction is not proved, and the antipyretic effect is probably related to different honeysuckle preparations, dosages or rabbit tolerance. 3. Strengthening the defense function: diluting the honeysuckle decoction to 1: 1280 has effects in promoting phagocytic function of leukocyte. The honeysuckle injection injected into the abdominal cavity of the mouse also has the function of obviously promoting the phagocytic function of inflammatory cells. 4. Central excitability: the experiment methods of electric shock, rotating cage and the like prove that after the chlorogenic acid is orally taken, the central nervous system of animals such as rats, mice and the like can be excited, the action intensity is 1/6 of caffeine, and the combination of the chlorogenic acid and the caffeine does not have addition and enhancement effects. 5. Blood fat reducing effect: the 2.5g/kg of honeysuckle flower for intragastric administration in rats can reduce the absorption of cholesterol in intestines and reduce the content of cholesterol in blood plasma. In vitro experiments also found that honeysuckle can be combined with cholesterol, but Simiaoyongan decoction (honeysuckle, figwort root, angelica and liquorice) treats experimental rabbit atherosclerosis. No effect of reducing blood lipid and aortic wall cholesterol content was observed. 6. Anti-endotoxin: endotoxin content was determined by limulus assay using 300% honeysuckle (lonicera japonica) injection at a ratio of 1: 2-1: 64 dilution, and obviously reducing the endotoxin content in the test solution in vitro tests by using a concave sheet method or a test tube method, wherein the ratio of 1: 2-1: the dilution tube of 8 was in a liquid state as the negative control tube, and the positive control tube was in a gel state. 6g/kg of honeysuckle flower (honeysuckle flower) distillate is intravenously injected, the honeysuckle flower (honeysuckle flower) distillate has an antagonistic effect on the rabbit body temperature reduction and the leucocyte number reduction caused by the intravenous injection of 2.8mg/kg of pyocyaneus endotoxin, 7.5g/kg of honeysuckle flower (honeysuckle flower) distillate or 2.5g/kg of injection is intraperitoneally injected, the honeysuckle flower (honeysuckle flower) distillate has a protective effect on mice intraperitoneally injected with 65mg/kg of pyocyaneus endotoxin, and the death rate of the mice is reduced. 7. Other functions are as follows: in vitro screening experiments have reported that water and wine soaking solutions of honeysuckle have obvious cytotoxic effects on sarcoma 180 and ehrlich ascites carcinoma. The honeysuckle extract has a mild prevention effect on experimental gastric ulcer of rats when being taken orally. The oral administration of chlorogenic acid with large dose can increase gastrointestinal motility and promote gastric juice and bile secretion. Chlorogenic acid and its decomposition product have exciting effect on isolated uterus of rat. In addition, chlorogenic acid can slightly enhance the boosting effect of epinephrine and norepinephrine on cats and rats, but has no influence on the prompt membrane reaction of cats.

The application and the use method of the film spraying agent of the invention are as follows:

the invention has wide application, including but not limited to the following applications:

1. burn wound: debridement and removal of necrotic tissue, direct spraying of the film-spraying agent of the invention to the wound surface and the surrounding area by 1-2cm, and covering or uncovering with other sterile dressings. The wound is observed every day, and if no effusion exists, the dressing change can be carried out once in 2-3 days; if the wound is red and swollen or the exudate is more, the wound should be debrided and the dressing should be changed in time. When changing medicine, the wound surface and the surrounding skin are cleaned by normal saline, and then the film spraying agent is sprayed again. The film spraying agent of the invention is continuously sprayed for 1-2 times per day after the wound surface is epithelialized. The small wound surface can be directly sprayed on the wound for 2 times per day.

2. Repairing the wound surface through cesarean section/abdominal operation: after the incision is sutured, the incision is cleaned by normal saline, the film spraying agent is directly sprayed on the incision and the periphery of the incision by 1-2cm, and other sterile dressings are used for covering. When the wound surface needs to be changed, the wound is debrided by normal saline, and the wound is bandaged after the film spraying agent is sprayed again. Scar inhibition: the incision and its surrounding area are sprayed continuously after the stitches are removed, without covering with dressing, 1-2 times per day. Can eliminate pigmentation around incision and inhibit scar formation.

3. And (3) reducing striae gravidarum: the parts such as the abdominal wall and the thighs are continuously sprayed in the puerperium and postnatal period, and proper local massage is matched to promote the retraction of the abdominal wall, prevent the abdominal wall from loosening and relieve the striae gravidarum. The film spraying agent is sprayed for 1-2 times every day, and before spraying, the skin of the sprayed part is cleaned by normal saline or warm water.

4. Lateral perineal incision: after the incision is sutured, the incision is cleaned by normal saline, and the wound surface can be protected and prevented from being polluted by urine and excrement liquid by spraying the film spraying agent; has antibacterial, antiinfectious, healing promoting, and healing time shortening effects, and is convenient for use. The vulva is cleaned and sprayed for 1 time after defecation each time, the vulva is cleaned and sprayed for 1 time before bedtime every night, the incision and skin around the incision are cleaned by normal saline or warm water during spraying, and then the film spraying agent is sprayed.

5. Nursing the navel and the hip of the newborn: the film spraying agent is sprayed on the umbilical region and the hip to prevent or treat skin problems such as local skin red swelling, skin erosion, skin ulcer and the like caused by diarrhea, diapers and the like. Spraying for 1-2 times per day.

6. Surgical incisions and wounds: after the incision is sutured, the incision or the wound is cleaned by normal saline, the film spraying agent is sprayed on the incision and the periphery of the incision by 1-2cm, and then the incision or the wound is covered by sterile dressing. When dressing change is needed, the wound surface and the skin around the mouth are cleaned by normal saline, and then the dressing is wrapped after the film spraying agent is sprayed again. After the stitches are removed, the film spraying agent is continuously sprayed on the incision and the periphery of the incision, so that the pigmentation around the incision can be eliminated, and the scar formation can be inhibited for 1 to 2 times per day.

7. And (3) ostomy care: (ileocectostomy, urostomy) washing: the film spraying agent of the invention is used for spraying the stoma and the surrounding skin from inside to outside 1 to 2 times per day. Not only can sterilize and disinfect, but also can avoid the dryness and the damage of the stoma caused by using soap solution or disinfectant. Skin care: the film spraying agent is sprayed on a stoma and the surrounding skin, so as to prevent or treat skin problems such as skin redness, swelling and pain, even ulcer and the like caused by long-time soaking of liquid dung and urine, 1 time per day. Relieving itching: the film spraying agent is sprayed on the stoma and the skin around the stoma to relieve itching.

8. Prevention and treatment of bedsores: the film spraying agent is sprayed on the high-incidence part of bedsore for 1-2 times per day when bedsore nursing is carried out on a patient. Without the need for covering with a dressing.

Compared with the prior art, the biological wound-protecting film spraying agent has the following advantages and remarkable progress:

(1) the film spraying agent has stronger sterilization and anti-infection capability, and has wide application and wider application range.

(2) The film spraying agent can promote the growth and repair of the wound surface, shorten the healing time, eliminate the pigmentation around the wound surface and inhibit the formation of scars.

(3) The film spraying agent has the advantages of high cure rate and rapid hemostasis and pain relief.

(4) The film spraying agent can promote the repair and regeneration of tissues and promote the rapid healing of wounds, and scars are slight even not left after healing.

Detailed Description

The following examples are given to further illustrate the embodiments of the present invention. The following description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the technical principle of the present invention, and these modifications and improvements should also be regarded as the protection scope of the present invention.

Example 1:

a marine organism wound-protecting film spraying agent is prepared from the following raw materials: 6kg of chitosan, 4 kg of chitosan oligosaccharide, 4 kg of lactic acid, 4 kg of aloe water extract, 4 kg of astragalus membranaceus, 4 kg of radix angelicae, 8kg of catechu and 4 kg of honeysuckle.

The preparation process comprises the following steps:

1) accurately weighing chitosan, chitosan oligosaccharide, lactic acid, aloe water extract, astragalus, angelica dahurica, catechu and honeysuckle according to the weight.

2) Pulverizing radix astragali, radix Angelicae Dahuricae, Catechu, and flos Lonicerae, mixing, adding 10 times of purified water, soaking for 12 hr, decocting under reflux for 1.5 hr, and filtering to obtain filtrate; adding purified water of which the weight is 5 times that of the traditional Chinese medicine, refluxing and decocting for 1 hour, filtering, combining the two filtrates, and concentrating to 1/2 of the original volume to obtain a traditional Chinese medicine concentrated solution for later use;

3) adding Aloe powder into purified water, heating to 60 + -2 deg.C, stirring, extracting for 2 hr, filtering, concentrating the filtrate, and drying to obtain Aloe water extract;

Example 2:

a marine organism wound-protecting film spraying agent is prepared from the following raw materials: 8kg of chitosan, 4 kg of chitosan oligosaccharide, 8kg of lactic acid, 6kg of aloe water extract, 6kg of astragalus membranaceus, 6kg of radix angelicae, 8kg of catechu and 8kg of honeysuckle.

The preparation process comprises the following steps:

2) Pulverizing radix astragali, radix Angelicae Dahuricae, Catechu, and flos Lonicerae, mixing, adding 8 times of purified water, soaking for 12 hr, decocting under reflux for 2 hr, and filtering to obtain filtrate; adding purified water 6 times the weight of the Chinese medicinal materials, decocting under reflux for 1 hr, filtering, mixing the filtrates, and concentrating to 1/3 of the original volume to obtain Chinese medicinal concentrated solution;

Example 3:

a marine organism wound-protecting film spraying agent is prepared from the following raw materials: 6kg of chitosan, 6kg of chitosan oligosaccharide, 3kg of lactic acid, 3kg of aloe water extract, 3kg of astragalus membranaceus, 3kg of radix angelicae, 6kg of catechu and 3kg of honeysuckle.

The preparation process comprises the following steps:

2) Pulverizing radix astragali, radix Angelicae Dahuricae, Catechu, and flos Lonicerae, mixing, adding 8 times of purified water, soaking for 12 hr, decocting under reflux for 1 hr, and filtering to obtain filtrate; adding purified water 4 times the weight of the Chinese medicinal materials, decocting under reflux for 1.5 hr, filtering, mixing filtrates, and concentrating to 1/3 to obtain Chinese medicinal concentrated solution;

4) adding chitosan, chitosan oligosaccharide, lactic acid and the aloe water extract obtained in the step 3) into the Chinese medicinal concentrated solution obtained in the step 2), stirring until the chitosan, chitosan oligosaccharide and aloe water extract are completely dissolved, and concentrating to obtain a mixed solution;

Experimental example 1: skin irritation test of the film spray

1. Experimental methods

Applying depilatory uniformly on both sides of spinal column of guinea pig to remove hair within 20cm². Cleaning the depilatory, returning to a cage for observation for 24 hours, spraying and coating the spray film agent produced in the embodiment 1 of the invention on the depilatory area of one group of guinea pigs respectively, wherein the spray film agent respectively comprises 0.3g, 0.6g and 1.2g of raw materials, and coating the solvent of the other group of guinea pigs twice a day for one continuous week, after the experiment is finished, the guinea pigs are killed, and the heart, the liver, the kidney and the depilatory skin are subjected to pathological examination.

2. Results

The above three groups of guinea pigs with drug have no topical skin edema, hyperemia, erythema, bleeding spot and ulcer. The hair color, ingestion, limb activity and the like of the guinea pigs in the drug administration group have no obvious difference with those in the control group, and the pathological histological examination shows that the heart, the liver, the kidney and the fur of the drug administration group have no obvious difference with those in the control group. The results suggest that the film spraying agent of the invention has no local stimulation and no systemic toxicity.

The film spraying agent is safe to use.

Experimental example 2: experimental study on promotion of perianal abscess postoperative rat model wound healing by using film spraying agent

1. Medicine for experiment

Control drug: the specification of the film spraying agent prepared by the preferred technical scheme in the Chinese invention patent No. 201210178375.8 is 0.11g raw material/g film spraying agent (chitosan 2%, chitosan oligosaccharide 1%, lactic acid 1.1%, aloe water extract 6%, and the balance water).

Experimental drugs: the specification of the film spraying agent produced in the embodiment 1 of the invention is 0.10g of raw material/g of film spraying agent.

2. Molding die

Clean Wistar rats 110, male and female halves, body mass 220 + -20 g, were anesthetized by intraperitoneal injection with 1% ketamine hydrochloride (3 ml/kg). Preparing skin locally, sterilizing conventionally, cutting 1 circular incision with diameter of 1cm on the back of rat, cutting skin full layer and subcutaneous superficial fascia to muscle layer, adding 1ml of liquid dung (5 g of fresh feces of normal person, 5ml of normal saline, mixing uniformly, centrifuging, taking supernatant, preparing for use), fixing with oil gauze, dressing and adhesive tape, removing cover after 48h, and successfully modeling patients with purulent secretion and feces odor in wound.

3. Experiment grouping and experiment method

The 96 rats successfully molded were randomly selected and randomly divided into three groups: model control group, control drug control group, experimental group, 32 rats each. The rats in each group adopt normal saline to clean wounds, adopt iodophor to disinfect, and wrap dressings. Wherein, the model control group is administrated by intraperitoneal injection of 14 ten thousand units of penicillin sodium/kg, and the wounds are respectively cleaned by physiological saline in the morning, at the noon and at the evening every day. The control group of the control drug is administrated by intraperitoneal injection according to 14 ten thousand units/kg of penicillin sodium, and is treated by the film spraying agent of the control drug respectively once a day in the morning, at noon and at night. The test group was treated by spraying the film-spraying agent prepared in example 1 with the intraperitoneal injection of 14 ten thousand units/kg of penicillin sodium once a day in the morning, at noon and at night.

At 3 rd, 7 th, 10 th and 14 th days after model building, the rats are killed in 4 batches (each batch comprises 8 rats), granulation tissues of 0.5cm multiplied by 0.5cm are cut from wound edges, the granulation tissues are placed in Carnot liquid for fixing for 45min, paraffin is embedded and sliced, conventional HE staining is carried out, and observation is carried out by adopting an optical lens and an MPIAS-500 color pathological image-text analysis system.

4. Results of the experiment

The calculation formula of the wound closure index is as follows: wound closure index = (1-wound area after treatment/original wound area) × 100%, the results are as followsSD indicates statistical treatment using the inter-group t test, and the results are shown in table 1. Further, 5 fields were observed for each specimen, the number of fibroblasts in granulation tissue was counted, and the average value (number of fibroblasts/field) was obtained as a resultSD indicates statistical treatment using the inter-group t test, and the results are shown in table 2.

TABLE 1 comparison of wound closure indices for each group: (±SD，n=8）

Comparison with model groups: p < 0.05, P < 0.01; compared with a reference medicine group: # P < 0.05.

TABLE 2 comparison of the number of fibroblasts in the granulation tissue of the wound surface of each group: (±SD，n=8）

5. Conclusion of the experiment

The experimental results in tables 1 and 2 show that, compared with the model control group, the control drug group and the experimental group respectively have significant difference (P < 0.05) or very significant difference (P < 0.01) in the aspects of rat wound closure index or fibroblast number along with the passage of time, which indicates that the control drug and the composition of the invention can improve the content of wound granulation tissue fibroblasts, thereby effectively and rapidly promoting the wound healing; compared with a control medicine group, the composition has significant difference (P is less than 0.05) in the aspects of rat wound closure index or fibroblast number, which shows that the composition is significantly superior to a control medicine in the aspect of effectively and rapidly promoting wound healing, and obtains unexpected technical effect.

Experimental example 3: clinical trial

1. General data

100 patients with burn and scald, 100 patients with surgical incision and 100 patients needing bedsore prevention are collected in the clinical test; the patients were equally divided into control and test groups according to disease species, so that the two groups were statistically comparable in age, sex, course of disease, and the like.

2. Test drug

3. Test method

After the wounds of two groups of patients are treated conventionally, respectively and uniformly spraying a control drug and an experimental drug, and continuously treating for 20 days for 2 times per day on the basis of uniformly covering and slightly increasing the wound range by 1-2 cm; and (5) counting the treatment condition of the patient after the treatment is finished, and carrying out statistical analysis.

4. Evaluation criteria

And (3) curing: the wound is completely healed, and the medicine is not needed any more;

the effect is shown: the wound is substantially healed or scabbed;

the method has the following advantages: the wound is obviously reduced, and the inflammation and other performances are reduced;

and (4) invalidation: the wound was not significantly improved or even more severe.

5. Test results

After the test was completed, the statistical analysis of the test results is shown in Table 3.

TABLE 3 statistical analysis of test results

The data in table 3 show that the film spraying agent provided by the invention has good cure rate (both 90.0% and 80.0% or more) and total effective rate (both 100%) for both burn and scald patients and patients with surgical incisions; the treatment effect is obviously better than that of a reference medicine group. In addition, the patients in the treated experimental group generally have slight scars or no scars, while the patients in the control group generally have slight scars or severe scars.

Thus, the compositions of the present invention provide a breakthrough technical advance over the prior art, with unexpected technical results in the healing of skin wounds.

No patients who sprayed the film-spraying agent of the present invention to prevent bedsores developed bedsores, and 13 patients who sprayed the control drug to prevent bedsores developed bedsores. Therefore, the effect of the film spraying agent for preventing bedsore is obviously better than that of a reference drug.

Claims

1. The marine organism wound-protecting film spraying agent is characterized by being prepared from the following raw materials: 6 parts of chitosan, 4 parts of chitosan oligosaccharide, 4 parts of lactic acid, 4 parts of aloe water extract, 4 parts of astragalus membranaceus, 4 parts of radix angelicae, 8 parts of catechu and 4 parts of honeysuckle;

the marine organism wound-protecting film spraying agent is prepared by the following method:

1) weighing the following raw materials: 6 parts of chitosan, 4 parts of chitosan oligosaccharide, 4 parts of lactic acid, 4 parts of aloe water extract, 4 parts of astragalus membranaceus, 4 parts of radix angelicae, 8 parts of catechu and 4 parts of honeysuckle;