CN111110831B - Ulcer paste and preparation method thereof - Google Patents
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Abstract
The invention discloses an ulcer paste, which consists of the following components: 100-500 ten thousand units of nystatin, 3-10 ml of lidocaine, 3-8 g of montmorillonite powder, 2-10 ml of sodium chloride injection with the mass concentration of 0.9%, 10-25 ug of recombinant human granulocyte stimulating factor injection, 5-10 ml of rehabilitation new liquid, 0.8-1.2 g of metronidazole tablets, 0.1-1 g of chitosan, 0.1-2 ml of acetic acid and 0.2-10 g of pectin are wrapped by one layer of chitosan, and the prepared ulcer paste is secondarily wrapped by pectin, so that the adhesion is strong, no peculiar smell is felt, and various components in the formula are matched with each other, so that the plaster has the effects of anti-inflammatory, pain relieving, promoting wound healing, strong adhesive force and safe and effective treatment on patients with the concurrent oral ulcer after chemotherapy and hematopoietic stem cell transplantation.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to ulcer paste and a preparation method thereof.
Background
Patients with tumors, especially patients with hematological malignancies, frequently develop canker sores, pain, eating and prolonged recovery time from disease, and severe sepsis may occur. At present, antibiotics are applied to the treatment of the oral ulcer of the patients, gargle, topical ulcer powder and the like. Systemic antibiotics are effective against ulcer co-infection, but ineffective against non-infected patients. The various gargle components are single, and the action time is short. The external ulcer powder has low adhesive force, is easy to fall off under the action of saliva, and is difficult to continuously produce action.
Montmorillonite powder (Montmorillonite powder) has an important role in the treatment of acute diarrhea. The montmorillonite powder is the montmorillonite powder containing dioctahedral, has a layered structure and non-uniform charge distribution, has selective adsorption effect on digestive tracts, particularly has extremely strong fixing and inhibiting effects on viruses in the digestive tracts, has extremely strong covering power on digestive tract mucous membranes, and can improve the defensive power of mucous membrane barriers to attack factors by combining with mucous glycoprotein. However, the montmorillonite powder has not been studied for the treatment of canker sore. Although human saliva contains a lot of mucins, it can also be combined with montmorillonite powder, when a patient speaks or eats, the montmorillonite powder attached to canker sore is easy to fall off due to oral cavity movement, and the drug effect is affected. Thus improving the adhesive force of the ulcer medicament and helping to improve the treatment effect of the ulcer medicament.
Disclosure of Invention
The invention solves the technical problems that antibiotics cannot be applied to all ulcers in the prior art, the gargle has single component, short acting time, external ulcer powder is easy to fall off under the action of saliva and difficult to continuously act, and aims at developing an ulcer paste which is anti-inflammatory, analgesic, wound healing promoting, strong in adhesive force, safe and effective for patients with the concurrent canker sore after chemotherapy and hematopoietic stem cell transplantation.
In order to solve the problems, the invention adopts the following technical scheme:
an ulcer paste, which consists of the following components: 100 to 500 ten thousand units of nystatin, 3 to 10ml of lidocaine, 3 to 8g of montmorillonite powder, 5 to 10ml of sodium chloride injection with the mass concentration of 0.9 percent, 10 to 25ug of recombinant human granulocyte stimulating factor injection, 5 to 10ml of rehabilitation new liquid, 0.8 to 1.2g of metronidazole tablets, 0.1 to 1g of chitosan, 0.1 to 2ml of acetic acid and 0.2 to 10g of pectin.
The mass concentration of the hydrogen peroxide is 0.1-1% of the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablets, the rehabilitation new liquid, the chitosan and the acetic acid;
and the molar concentration of the calcium chloride solution is not lower than 8mol/L, and the ratio of the calcium chloride solution to the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablets, the rehabilitation new liquid, the chitosan, the acetic acid, the sodium chloride injection and the recombinant human granulocyte stimulating factor injection is 10ml to 80-100 mg.
Wherein the molecular weight of the pectin is not lower than 50000Da, and the esterification degree is 68-70%.
Wherein the chitosan is oligomeric chitosan, and the molecular weight of the oligomeric chitosan is 4000-6000.
The preparation method of the ulcer paste comprises the following steps:
(1) Mixing montmorillonite, lidocaine, nystatin, metronidazole tablets and rehabilitation new liquid, and stirring uniformly for standby;
(2) Dissolving chitosan in acetic acid solution, adding the mixture obtained in the step (1) into the chitosan acetic acid solution, and uniformly stirring for later use;
(3) Adding 0.1-1% hydrogen peroxide by mass of the mixture obtained in the step (2), heating to 60-80 ℃, and radiating by ultrasonic waves for 2-7 h at the temperature;
(4) Mixing sodium chloride injection with recombinant human granulocyte stimulating factor injection, adding pectin, and stirring;
(5) And (3) placing the products obtained in the step (3) and the step (4) into a calcium chloride solution, and uniformly stirring to obtain the ulcer paste.
Wherein the molar concentration of the calcium chloride solution is not lower than 8mol/L, and the mixing ratio of the calcium chloride solution and the total product obtained in the step (3) and the step (4) is 10 ml/100 mg.
Wherein the ultrasonic strength is 2.5-4W/cm 2 。
Because pectin and chitosan have certain swelling property, the ulcer paste is prevented from swelling in the mouth to cause oral discomfort, and in the preferred scheme of the application, the ulcer paste just prepared is preferably used after being kept still for more than 5 minutes, so that the comfort level of the ulcer paste can be improved.
The recombinant human granulocyte stimulating factor injection used in the invention can adopt 0.9% sodium chloride injection to flush residual liquid obtained by the recombinant human granulocyte stimulating factor.
Compared with the prior art, the invention has the following beneficial effects:
(1) According to the invention, montmorillonite powder, lidocaine, nystatin and rehabilitation new liquid are mixed and then coated by a layer of chitosan, so that the chitosan can better embed medicines and form a stable film structure. The saliva of the human body contains not only 99% of water, but also salivary amylase, mucopolysaccharide, mucin, lysozyme, sodium, potassium, calcium and the like, the pH value of the saliva is 6.6-7.1, chitosan is not easy to dissolve in saliva and water, and the chitosan-embedded medicament is difficult to release and exert the medicament property. The application adds a trace amount of hydrogen peroxide as an auxiliary agent, and the ultrasonic intensity is 2.5-4W/cm 2 Under the radiation of ultrasonic wave, the structural film of chitosan is modified, the molecular weight of chitosan is reduced, so that the chitosan can be well dissolved in saliva, and medicine is releasedThe composition can be used for treating stomatocace. In order to improve the comfort and the drug effect of the ulcer paste, the application also adopts pectin to carry out secondary package to form a pectin outer layer, so that the adhesive force of the ulcer paste is improved, and the ulcer paste is not easy to fall off. Specifically, the mixture of the sodium chloride injection, the recombinant human granulocyte stimulating factor injection and pectin and the chitosan mixture are dissolved in a high-concentration calcium ion solution, and under the action of calcium ions, the chitosan and pectin network structure layer is loose, so that medicines such as medicine montmorillonite powder, lidocaine, nystatin, rehabilitation solution and the like are easy to exude to exert medicine property, meanwhile, the ulcer paste can form soft and wet hydrogel to be adhered to the ulcer wound, discomfort caused by roughness of the ulcer paste is reduced, meanwhile, the hydrogel can be strongly adhered to an affected part, the ulcer paste also has a lubricating effect, and the prepared ulcer paste is not easy to fall off, and the curative effect is improved.
(2) The nystatin tablet adopted in the invention is an antifungal drug, has an anti-inflammatory effect, lidocaine has a local anesthetic and an analgesic effect, montmorillonite powder has an antidiarrheal drug, has a convergence and detumescence effect, increases the effect of drug attachment, has a synergistic effect by sodium chloride injection with the mass concentration of 0.9% and recombinant human granulocyte stimulating factor injection containing recombinant human granulocyte stimulating factor, and has effects of promoting cell generation and wound healing, promoting blood vessels, nourishing yin and promoting granulation, and the metronidazole tablet has a killing effect on anaerobic microorganism bacteria, and a plurality of components are mutually matched, so that the invention has the effects of resisting inflammation, easing pain, promoting wound healing, having strong adhesive force, being safe and effective for patients with oral ulcer after chemotherapy and hematopoietic stem cell transplantation. The various medicines are mixed into paste, and the paste is smeared on canker sore for 2-3 times a day. Through early clinical verification, the traditional Chinese medicine has good effect, saves medical cost, has short treatment course time, takes effect quickly and has no adverse side effect.
Drawings
FIG. 1 is an ulcer paste of the present invention.
Fig. 2 is a physical diagram of a product prepared by the control group 1 of the present application.
Detailed Description
The invention is further illustrated by the following examples and experiments.
Example 1
An ulcer paste, which consists of the following components: 500 ten thousand units of nystatin, 3ml of lidocaine, 8g of montmorillonite powder, 5ml of sodium chloride injection with the mass concentration of 0.9%, 25ug of recombinant human granulocyte stimulating factor injection, 5ml of rehabilitation new liquid, 0.8g of metronidazole tablets, 1g of chitosan, 0.1ml of acetic acid and 10g of pectin, wherein the molecular weight of the pectin is 50000Da, and the esterification degree is 68%. The chitosan is oligomeric chitosan, and the molecular weight of the oligomeric chitosan is 400;
the mass concentration of the hydrogen peroxide is 1% of the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablets, the rehabilitation new liquid, the chitosan and the acetic acid;
and the molar concentration of the calcium chloride solution is 8mol/L, and the ratio of the total mass of the calcium chloride solution to the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablet, the rehabilitation new liquid, the chitosan, the acetic acid, the sodium chloride injection and the recombinant human granulocyte stimulating factor injection is 10ml to 100mg.
The preparation method comprises the following steps:
(1) Mixing montmorillonite, lidocaine, nystatin, metronidazole tablets and rehabilitation new liquid, and stirring uniformly for standby;
(2) Dissolving chitosan in acetic acid solution, adding the mixture obtained in the step (1) into the chitosan acetic acid solution, and uniformly stirring for later use;
(3) Adding 1% hydrogen peroxide by mass of the mixture into the mixture obtained in the step (2), heating to 60 ℃, and radiating by ultrasonic waves at the temperature for 7 hours; the ultrasonic intensity is 2.5W/cm 2 ；
(4) Mixing sodium chloride injection with recombinant human granulocyte stimulating factor injection, adding pectin, and stirring;
(5) And (3) placing the products obtained in the step (3) and the step (4) into a calcium chloride solution, and uniformly stirring to obtain the ulcer paste. The mixing ratio of the calcium chloride solution and the total product obtained in the step (3) and the step (4) is 10ml to 100mg.
Example 2
An ulcer paste, which consists of the following components: 100 ten thousand units of nystatin, 10ml of lidocaine, 3g of montmorillonite powder, 10ml of sodium chloride injection with the mass concentration of 0.9%, 10ug of recombinant human granulocyte stimulating factor injection, 10ml of rehabilitation new liquid, 1.2g of metronidazole tablets, 0.1g of chitosan, 2ml of acetic acid and 0.2g of pectin, wherein the molecular weight of the pectin is 60000Da, and the esterification degree is 70%. The chitosan is oligomeric chitosan, and the molecular weight of the oligomeric chitosan is 6000;
the mass concentration of the hydrogen peroxide is 0.1% of the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablets, the rehabilitation new liquid, the chitosan and the acetic acid;
and the molar concentration of the calcium chloride solution is not lower than 8mol/L, and the ratio of the calcium chloride solution to the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablets, the rehabilitation new liquid, the chitosan, the acetic acid, the sodium chloride injection and the recombinant human granulocyte stimulating factor injection is 10ml to 80mg.
The preparation method comprises the following steps:
(1) Mixing montmorillonite, lidocaine, nystatin, metronidazole tablets and rehabilitation new liquid, and stirring uniformly for standby;
(2) Dissolving chitosan in acetic acid solution, adding the mixture obtained in the step (1) into the chitosan acetic acid solution, and uniformly stirring for later use;
(3) Adding hydrogen peroxide accounting for 0.1% of the mass of the mixture into the mixture obtained in the step (2), heating to 80 ℃, and radiating by ultrasonic waves for 2 hours at the temperature; the ultrasonic intensity is 4W/cm 2 ；
(4) Mixing sodium chloride injection with recombinant human granulocyte stimulating factor injection, adding pectin, and stirring;
(5) And (3) placing the products obtained in the step (3) and the step (4) into a calcium chloride solution, and uniformly stirring to obtain the ulcer paste. The mixing ratio of the calcium chloride solution and the total product obtained in the step (3) and the step (4) is 10 ml/80 mg.
Example 3
An ulcer paste, which consists of the following components: 300 ten thousand units of nystatin, 5ml of lidocaine, 6g of montmorillonite powder, 8ml of sodium chloride injection with the mass concentration of 0.9%, 15ug of recombinant human granulocyte stimulating factor injection, 8ml of rehabilitation new liquid, 1.0g of metronidazole tablets, 0.5g of chitosan, 1ml of acetic acid and 5g of pectin, wherein the molecular weight of the pectin is 70000Da, and the esterification degree is 69%. The chitosan is oligomeric chitosan, and the molecular weight of the oligomeric chitosan is 5000;
the mass concentration of the hydrogen peroxide is 0.5% of the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablets, the rehabilitation new liquid, the chitosan and the acetic acid;
and the molar concentration of the calcium chloride solution is not lower than 8mol/L, and the ratio of the calcium chloride solution to the total mass of the montmorillonite, the lidocaine, the nystatin, the metronidazole tablets, the rehabilitation new liquid, the chitosan, the acetic acid, the sodium chloride injection and the recombinant human granulocyte stimulating factor injection is 10ml to 90mg.
The preparation method comprises the following steps:
(1) Mixing montmorillonite, lidocaine, nystatin, metronidazole tablets and rehabilitation new liquid, and stirring uniformly for standby;
(2) Dissolving chitosan in acetic acid solution, adding the mixture obtained in the step (1) into the chitosan acetic acid solution, and uniformly stirring for later use;
(3) Adding hydrogen peroxide accounting for 0.5% of the mass of the mixture into the mixture obtained in the step (2), heating to 70 ℃, and radiating by ultrasonic waves at the temperature for 5 hours; the ultrasonic intensity is 3W/cm 2 ；
(4) Mixing sodium chloride injection with recombinant human granulocyte stimulating factor injection, adding pectin, and stirring;
(5) And (3) placing the products obtained in the step (3) and the step (4) into a calcium chloride solution, and uniformly stirring to obtain the ulcer paste. The mixing ratio of the calcium chloride solution and the total product obtained in the step (3) and the step (4) is 10 ml/90 mg.
Control group 1
The control group 1 ulcer paste was substantially the same as the ulcer paste of example 1, except that the control group 1 ulcer paste did not contain chitosan, acetic acid, pectin, nor hydrogen peroxide and calcium chloride solution, i.e., was not treated with hydrogen peroxide and calcium chloride solution.
The preparation method comprises the following steps: grinding nystatin, lidocaine, montmorillonite powder and metronidazole tablet into powder according to a certain proportion, adding sodium chloride injection with mass concentration of 0.9%, recombinant human granulocyte stimulating factor injection and rehabilitation new liquid according to a certain proportion, and making into paste to obtain the ulcer paste.
Control group 2
The control group 2 ulcer paste was substantially the same as the ulcer paste of example 1, except that the control group 2 was prepared by the same method as that of example 1 without using hydrogen peroxide to treat chitosan.
Control group 3
The ulcer paste of control group 3 was substantially the same as that of example 1, except that the preparation method of control group 3 was not treated with hydrogen peroxide and ultrasonic irradiation to chitosan, and the remaining preparation steps were the same as those of example 1.
Control group 4
The control group 4 ulcer paste was substantially the same as the ulcer paste of example 1, except that the control group 4 was prepared without secondary entrapment using pectin, and the remaining preparation steps were the same as the ulcer paste of example 1.
Control group 5
Control group 5 the ulcer paste was substantially the same as the ulcer paste of example 1, except that step (5) of the control group 5 preparation method was: and (3) mixing and stirring the products obtained in the step (3) and the step (4) uniformly to obtain the ulcer paste, wherein the other preparation steps are the same as the preparation method of the ulcer paste in the example 1.
Control group 6
The control group 6 ulcer paste was substantially the same as the ulcer paste of example 1, except that in the preparation method of control group 6, the concentration of the calcium chloride solution used was 5mol/L, and the remaining preparation steps were the same as the preparation method of the ulcer paste of example 1.
Control group 7
The control group 7 ulcer paste was substantially the same as the ulcer paste of example 1, except that the control group 7 was prepared by using a calcium chloride solution having a concentration of 2mol/L, and the remaining preparation steps were the same as those of the ulcer paste of example 1.
Ulcer paste adhesion test
The ulcer pastes prepared in examples 1 to 3 and control groups 1 to 7 were left to stand for 5 minutes and then applied to the canker sore, and after application, they were not eaten or drunk, and after the ulcer paste was dropped, the adhesion time was counted while the sensation of the ulcer paste in the mouth was perceived, the sensation of the ulcer paste in the mouth was evaluated with reference to the sensory evaluation criteria in table 1 below, and the results are shown in table 2 below.
TABLE 1
TABLE 2
As can be seen from table 2, the ulcer paste adhesion time: examples 1 to 3> control group 2, control group 3, control group 6, control group 7> control group 4> control group 1, and it is demonstrated that the ulcer paste prepared by the method of the invention has strong adhesiveness at the canker sore after two-time coating with chitosan and pectin, and is beneficial to improving the curative effect of the ulcer paste. Whereas control 1 without any treatment had the worst adhesion, and was not treated with the pectin secondary coated ulcer paste. The adhesive property of the ulcer paste of chitosan which is not treated by hydrogen peroxide and chitosan and the adhesive property of the ulcer paste of pectin mixture and chitosan mixture which are directly mixed by pectin mixture and low-concentration calcium solution are reduced. The ulcer paste of the present application in combination with fig. 1 is relatively viscous in appearance and strong in adhesion, and fig. 2 is a physical image of the ulcer paste product of the control group 1 of the present application, which is thin in appearance, weak in adhesion in the oral cavity and poor in adhesion, and just illustrates that the ulcer paste of the present application has a strong adhesion effect. As can also be seen in table 2, the ulcer paste of the present application senses: the ulcer pastes of examples 1 to 3 had no foreign body sensation, had a smooth sensation, and were normally secreted by saliva, indicating that the ulcer pastes of the present invention were strong in comfort, whereas the control groups 2 to 7, particularly the control group 1, showed strong foreign body sensation, indicating that the ulcer pastes treated without chitosan and pectin had foreign body sensation, and were more secreted by saliva, whereas the ulcer pastes of examples 1 to 3 and the control groups 5 to 7 were less lubricious, had a bad smell sensation, and were more secreted by saliva, as compared with the case where pectin was not treated with calcium ions. The invention adopts chitosan to wrap the medicine components for the first time, and adopts pectin to carry out secondary embedding, thus improving the adhesiveness and the comfort of the ulcer paste.
The foregoing description is directed to the preferred embodiments of the present invention, but the embodiments are not intended to limit the scope of the invention, and all equivalent changes or modifications made under the technical spirit of the present invention should be construed to fall within the scope of the present invention.
Claims (6)
1. A method for preparing a canker sore paste, comprising the steps of:
(1) Mixing montmorillonite, lidocaine, nystatin, metronidazole tablets and rehabilitation new liquid, and stirring uniformly for standby;
(2) Dissolving chitosan in acetic acid solution, adding the mixture obtained in the step (1) into the chitosan acetic acid solution, and uniformly stirring for later use;
(3) Adding 0.1-1% hydrogen peroxide by mass of the mixture obtained in the step (2), heating to 60-80 ℃, and radiating by ultrasonic waves at the temperature for 2-7 hours;
(4) Mixing sodium chloride injection with recombinant human granulocyte stimulating factor injection, adding pectin, and stirring;
(5) Placing the products obtained in the step (3) and the step (4) into a calcium chloride solution, and uniformly stirring to obtain the ulcer paste; the molar concentration of the calcium chloride solution is not lower than 8mol/L, and the mixing ratio of the calcium chloride solution and the total product obtained in the step (3) and the step (4) is 10ml:100mg.
2. The method for producing a canker sore paste according to claim 1, wherein the pectin has a molecular weight of not less than 50000Da and an esterification degree of 68 to 70%.
3. The method for preparing the canker sore paste according to claim 1, wherein the chitosan is oligomeric chitosan, and the molecular weight of the oligomeric chitosan is 4000-6000.
4. The method for producing canker sore paste according to claim 1, wherein the ultrasonic intensity is 2.5 to 4w/cm 2 。
5. The method of claim 1, wherein the paste is used for more than 5 minutes after the preparation of the paste.
6. A dental ulcer paste prepared by the method for preparing a dental ulcer paste according to any one of claims 1 to 5.
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