CN115025125A - A pharmaceutical composition for treating oral ulcer and preparation method thereof - Google Patents
A pharmaceutical composition for treating oral ulcer and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of ulcer treatment medicines, and particularly relates to a pharmaceutical composition for treating oral ulcer and a preparation method thereof. The pharmaceutical composition comprises the following components in parts by weight: 3.33-80 parts of pearl powder, 0.33-10 parts of menthol, 0.033-4 parts of dexamethasone sodium phosphate and 1.238-3.238 parts of dyclonine hydrochloride. The composition disclosed by the invention can generate good pain relieving and treating effects on oral ulcer, and the temperature-sensitive gel prepared in the preferable scheme is good in stability and has good application prospects.
Description
Technical Field
The invention belongs to the technical field of ulcer treatment medicines, and particularly relates to a pharmaceutical composition for treating oral ulcer and a preparation method thereof.
Background
Oral erosion is a superficial defect of the oral mucosa, which is a partial lesion of the epithelium without damaging the basal cell layer. Canker sores are the persistent loss or destruction of the integrity of the epithelium of the oral mucosa, with the surface layer necrotizing and falling off to form a depression. Oral mucosa erosion and ulcer can occur in various oral mucosa diseases, including erosive oral lichen planus, radiotherapy and chemotherapy oral mucositis, recurrent aphthous ulcer, traumatic ulcer, etc. Oral erosion and ulcer are accompanied by pains of different degrees, which affect normal physiological functions of eating, speaking, swallowing, chewing and the like and the life quality of patients. Therefore, the oral mucosa pain relieving capsule can promote erosion and ulcer healing while relieving oral mucosa pain remarkably, and has important clinical significance.
At present, external medicines are commonly used for treating oral ulcer. For example, "CN 104490920A a patch for treating oral ulcer and method for preparing the same" provides a patch for treating oral ulcer, the active ingredients of which mainly include dyclonine hydrochloride, chlortetracycline hydrochloride, metronidazole, dexamethasone sodium phosphate, etc. However, the existing external medicine still has a plurality of problems, such as the external medicine is easy to generate foreign body sensation in the oral cavity, has discomfort and poor treatment effect and is difficult to effectively eliminate pain. Therefore, there is still a need to develop new drugs for treating oral ulcer, which provides more options for treating oral ulcer.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a pharmaceutical composition for treating oral ulcer and a preparation method thereof, and aims to provide more options for treating oral ulcer.
A pharmaceutical composition for treating oral ulcer comprises the following components in parts by weight:
3.33 to 80 parts of pearl powder,
0.33-10 parts of menthol,
0.033-4 parts of dexamethasone sodium phosphate,
1.238-3.238 parts of dyclonine hydrochloride.
Preferably, the composition comprises the following components in parts by weight:
16.675-36.675 parts of pearl powder,
2.563-4.563 parts of menthol,
0.438-0.638 part of dexamethasone sodium phosphate,
1.238-3.238 parts of dyclonine hydrochloride.
Preferably, the composition comprises the following components in parts by weight:
28.675 portions of pearl powder,
3.583 parts of menthol,
Dexamethasone sodium phosphate 0.539 parts,
And 3.089 parts of dyclonine hydrochloride.
Preferably, the composition comprises a gelata and a dyclonine hydrochloride solid which are respectively packaged, wherein the gelata is obtained by dispersing pearl powder, menthol and dyclonine hydrochloride in poloxamer 407 temperature-sensitive gel.
Preferably, the gel consists of:
3.33-80 mg/ml of pearl powder,
0.33-10 mg/ml of menthol,
0.033-4 mg/ml dexamethasone sodium phosphate,
407160-200 mg/ml of poloxamer,
6.67-100 mg/ml of humectant,
The mucilage component is 2.33-11.41 mg/ml
The balance being water.
Preferably, it consists of:
16.675-36.675 mg/ml of pearl powder,
2.563-4.563 mg/ml of menthol,
0.438-0.638 mg/ml of dexamethasone sodium phosphate,
Poloxamer 407160-200 mg/ml,
30-50 mg/ml of humectant,
The mucilage component is 2.33-5.56 mg/ml
The balance being water.
Preferably, it consists of:
28.675mg/ml of pearl powder,
3.583mg/ml of menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
407199.5 mg/ml of poloxamer,
42.98mg/ml of humectant,
Mucilage component 3.682mg/ml
The balance being water.
Preferably, the humectant is selected from one or a mixture of two of orange juice, fish liver and glycerol.
Preferably, the glue solution component is one or a mixture of two of sodium carboxymethyl cellulose and polyvinyl alcohol.
The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:
step 2, adding pearl powder and menthol into the mixed solution A, and dissolving to obtain a mixed solution B;
step 3, dissolving sodium carboxymethylcellulose and polyvinyl alcohol in water to prepare a mixed solution C, and mixing the mixed solution B with the mixed solution C to obtain a mixed solution D;
and step 4, adding poloxamer 407 into the mixed solution D, and uniformly mixing to obtain the poloxamer.
The pharmaceutical composition can relieve the pain of ulcer parts, promote the healing of ulcer and has good treatment effect on oral ulcer. The preferred scheme of the invention prepares the drug composition which can be stably preserved for a long time and has temperature-sensitive characteristic by reasonably selecting the components, and the drug composition is aqueous solution at 4 ℃ and hydrogel at room temperature. Experiments show that the long-term stable storage of the pharmaceutical composition as an aqueous solution or hydrogel can be ensured only by adopting the selection of the components and the dosage of the components. The pharmaceutical composition can be further added with dyclonine hydrochloride to prepare temperature-sensitive hydrogel for treating oral ulcer, and the temperature-sensitive hydrogel has good treatment and pain relieving effects on oral ulcer and good application prospect.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Drawings
FIG. 1 is a schematic illustration of the package of example 1;
FIG. 2 is a photograph showing the temperature-sensitive characteristics of the temperature-sensitive ulcer gel of example 1;
FIG. 3 is a photograph showing the stability of the temperature sensitive ulcer gel of example 1;
FIG. 4 is a photograph showing the failure of comparative example 1 to form a stable gel;
FIG. 5 is a photograph showing the failure of comparative example 1 to form a stable gel;
fig. 6 is a photograph showing the failure of comparative example 2 to form a stable gel.
FIG. 7 is a photograph of the temperature sensitive ulcer gel of example 1 used on an ulcer;
FIG. 8 is a photograph showing the treatment results of the rat canker sore model treatment experiment in Experimental example 1;
FIG. 9 is a comparison of the treatment results of the rat canker sore model treatment experiment in Experimental example 1;
Detailed Description
In the following examples and experimental examples, reagents and materials not specifically described are commercially available.
Example 1
The embodiment is a temperature-sensitive ulcer gel which comprises dyclonine hydrochloride solid powder and a pharmaceutical composition with temperature-sensitive property, wherein the dyclonine hydrochloride solid powder is separately packaged by using a dry-wet separation fresh-keeping bottle. As shown in figure 1, the dry-wet separation fresh-keeping bottle is composed of an upper part and a lower part, and can realize the simultaneous separation and preservation of solid powder and gel (solution). The powder is stored in the upper primary and secondary covers, the lower part is used for storing gel (solution), and the gel (solution) is simple and convenient to use, can be opened at any time, and is small, exquisite and convenient. When the powder dropper is used, the bottle cap is pressed to release the powder, the powder is shaken forcibly, and the dropper cap is replaced after the powder is completely dissolved. The reason for the separate packaging is that dyclonine hydrochloride is unstable and easily decomposed in a liquid. In this example, dyclonine hydrochloride can be added to the pharmaceutical composition in the form of a solution prior to use by separating the packaging of the vial by dry and wet methods.
The pharmaceutical composition of this example consists of:
28.675mg/ml of pearl powder,
42.98mg/ml orange juice cod liver oil,
3.583mg/ml of menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
407199.5 mg/ml of poloxamer,
2.783mg/ml of sodium carboxymethylcellulose,
Polyvinyl alcohol 0.899mg/ml,
The balance being water.
The pharmaceutical composition is prepared by the following steps: dissolving pearl powder and menthol in 0.11ml orange juice cod liver oil and 2ml dexamethasone sodium phosphate solution by magnetic stirring in a dry-wet separation fresh-keeping bottle, and then adding 1ml of mucilage (prepared by dissolving mucilage sodium carboxymethyl cellulose and polyvinyl alcohol in 1ml of triple distilled water, adding water, then adding solid powder of the two compounds, standing at room temperature) and 5ml P407, and uniformly stirring. In this example, the prepared pharmaceutical composition was an aqueous solution at 4 ℃ and a hydrogel at room temperature. The total volume of which, when present as an aqueous solution, was 8 ml.
The pharmaceutical composition prepared by the above method can be stably stored at room temperature for a long time, wherein the pharmaceutical composition after 90 days of storage is shown in fig. 3.
In the embodiment, the final concentration of dyclonine hydrochloride in the temperature-sensitive ulcer gel obtained by mixing solid and liquid in the dry-wet separation preservation bottle is 3.089 mg/ml. The temperature-sensitive ulcer gel is aqueous solution at 4 ℃ and hydrogel at room temperature. As shown in fig. 3. The temperature-sensitive ulcer gel prepared by the method can be stored stably at room temperature, and the phenomena of layering and precipitation are avoided.
Example 2
The composition of this example was prepared and packaged in the same manner as in example 1 and had the composition:
80mg/ml of pearl powder,
100mg/ml of orange juice and cod liver oil,
10mg/ml of menthol,
Dexamethasone sodium phosphate 4mg/ml,
407200 mg/ml of poloxamer,
6.658mg/ml of sodium carboxymethyl cellulose,
4.755mg/ml polyvinyl alcohol
The balance being water.
Example 3
The composition of this example was prepared and packaged in the same manner as in example 1 and had the composition:
3.33mg/ml of pearl powder,
6.67mg/ml orange juice cod liver oil,
0.33mg/ml of menthol,
Dexamethasone sodium phosphate 0.033mg/ml,
407160 mg/ml of poloxamer,
1.663mg/ml of sodium carboxymethylcellulose,
Polyvinyl alcohol 0.668mg/ml
The balance being water.
Comparative example 1
This comparative example increased the concentration of a part of the components, and a pharmaceutical composition was prepared and packaged in the same manner as in example 1.
The composition of the pharmaceutical composition is as follows:
85.36mg/ml of pearl powder,
133.33mg/ml of glycerol,
Orange juice cod liver oil 42.67mg/ml
5.70mg/ml of menthol,
Dexamethasone sodium phosphate 1.72mg/ml,
407200 mg/ml of poloxamer,
2.783mg/ml of sodium carboxymethylcellulose,
Polyvinyl alcohol 0.899mg/ml,
The balance being water.
As a result, it was found that the pharmaceutical composition failed to form a stable gel and formed a large amount of precipitates at 4 deg.C, as shown in FIG. 5.
Comparative example 2
This comparative example uses glycerin instead of orange juice cod liver oil, and a pharmaceutical composition was prepared and packaged in the same manner as in example 1.
The composition of the pharmaceutical composition is as follows:
28.675mg/ml of pearl powder,
80mg/ml of glycerol,
3.583mg/ml of menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
Poloxamer 407199.5 mg/ml,
2.783mg/ml of sodium carboxymethyl cellulose,
0.899mg/ml of polyvinyl alcohol,
The balance being water.
As a result, it was found that the pharmaceutical composition failed to form a stable gel and formed a large amount of precipitates at 4 deg.C, as shown in FIG. 6.
Comparative example 3
This comparative example was prepared and packaged in the same manner as in example 1, with the addition of equal amounts of glycerin and orange juice cod liver oil.
The composition of the pharmaceutical composition is as follows:
28.675mg/ml of pearl powder,
40mg/ml of liver oil,
42.98mg/ml of orange juice and cod liver oil,
3.583mg/ml of menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
407199.5 mg/ml of poloxamer,
2.783mg/ml of sodium carboxymethyl cellulose,
0.899g/ml of polyvinyl alcohol,
The balance being water.
As a result, it was found that the pharmaceutical composition failed to form a stable gel and formed a large amount of precipitates at 4 deg.C, as shown in FIG. 7.
The advantageous effects of the present invention will be further described by experiments.
Experimental example 1 therapeutic Effect of temperature-sensitive ulcer gel
This Experimental example examines the therapeutic effect of the temperature-sensitive ulcer gel prepared in example 1
The temperature-sensitive ulcer gel product in a liquid form is dripped on the mucous membrane of the pig tongue in vitro to form hydrogel immediately. The liquid is dripped on the ulcer surface on the inner side of the lower lip of the rat, and the hydrogel is formed immediately. The same effect was observed on the inner ulcer surface of the human lower lip (fig. 7). Meanwhile, the pain of the ulcer part is completely relieved within 2 minutes after the product is used, the local tingling feeling can last for more than 30 minutes, and the healing of the oral ulcer can be remarkably promoted.
A50% glacial acetic acid solution is used for constructing a rat oral ulcer model, and the specific method comprises the following steps: SD male rats (with a body weight of about 220g) are anesthetized by intraperitoneal injection with 10% chloral hydrate (3mL/kg) and then fixed on an operating table, the mucous membrane on the inner side of the lower lip of the rat is wiped dry with a sterile cotton ball, the rat is insulated from moisture, a small cotton ball with a diameter of 4mm and 50% glacial acetic acid is placed on the mucous membrane on the inner side of the lower lip of the dried rat, and the small cotton ball is taken out after being kept for 45 s. After 48h of modeling, ulcers with clinical features of "yellow, red, concave" of the intra-labial mucosa below served as markers of successful modeling. The rats successfully modeled are randomly divided into two groups, temperature-sensitive ulcer gel is locally used in an experimental group, and triamcinolone acetonide ointment for clinically treating oral ulcer is used as a control, so that the temperature-sensitive gel can remarkably promote the healing of the oral ulcer of the rats. On the 4 th day, the 6 th day and the 8 th day of administration, the ulcer healing of rats treated by the temperature-sensitive gel is better than that of the triamcinolone acetonide ointment treatment group (the size difference of the ulcer has statistical significance, and p is less than 0.05); on day 8, the ulcers were all healed in the temperature sensitive gel group rats, but not in the triamcinolone acetonide ointment group rats (fig. 8 and 9). Therefore, the temperature-sensitive gel provided by the invention has a good effect of promoting oral healing.
As can be seen from the above examples and comparative examples, a stable temperature sensitive gel can be formed only by the preferred components and amounts thereof herein. The temperature-sensitive gel prepared by the invention can generate good pain relieving and treating effects on the oral ulcer, and has good application prospect.
Claims (10)
1. The pharmaceutical composition for treating the oral ulcer is characterized by comprising the following components in parts by weight:
3.33 to 80 parts of pearl powder,
0.33-10 parts of menthol,
0.033 to 4 parts of dexamethasone sodium phosphate,
1.238-3.238 parts of dyclonine hydrochloride.
2. The pharmaceutical composition according to claim 1, characterized in that it comprises the following ingredients in parts by weight:
16.675-36.675 parts of pearl powder,
2.563-4.563 parts of menthol,
0.438-0.638 part of dexamethasone sodium phosphate,
1.238-3.238 parts of dyclonine hydrochloride.
3. The pharmaceutical composition according to claim 1, comprising the following components in parts by weight:
28.675 portions of pearl powder,
3.583 parts of menthol,
Dexamethasone sodium phosphate 0.539 parts,
And 3.089 parts of dyclonine hydrochloride.
4. The pharmaceutical composition according to claim 1, wherein: the composition comprises a gel and a dyclonine hydrochloride solid which are respectively packaged, wherein the gel is obtained by dispersing pearl powder, menthol and dyclonine hydrochloride in poloxamer 407 temperature-sensitive gel.
5. The pharmaceutical composition according to claim 4, wherein said gelling agent consists of:
3.33-80 mg/ml of pearl powder,
0.33-10 mg/ml of menthol,
0.033-4 mg/ml dexamethasone sodium phosphate,
Poloxamer 407160-200 mg/ml,
6.67-100 mg/ml of humectant,
The mucilage component is 2.33-11.41 mg/ml
The balance being water.
6. The pharmaceutical composition according to claim 5, characterized in that it consists of:
16.675-36.675 mg/ml of pearl powder,
2.563-4.563 mg/ml of menthol,
0.438-0.638 mg/ml of dexamethasone sodium phosphate,
407160-200 mg/ml of poloxamer,
30-50 mg/ml of humectant,
The mucilage component is 2.33-5.56 mg/ml
The balance being water.
7. The pharmaceutical composition according to claim 6, characterized in that it consists of:
28.675mg/ml of pearl powder,
3.583mg/ml of menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
407199.5 mg/ml of poloxamer,
42.98mg/ml of humectant,
Mucilage component 3.682mg/ml
The balance being water.
8. The pharmaceutical composition according to claim 1, wherein: the humectant is one or a mixture of two of orange juice, fish liver and glycerol.
9. The pharmaceutical composition according to claim 1, wherein: the glue solution component is one or a mixture of two of sodium carboxymethyl cellulose and polyvinyl alcohol.
10. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 9, comprising the steps of:
step 1, dissolving dexamethasone sodium phosphate in water, and then mixing the dexamethasone sodium phosphate with orange juice and cod liver oil to obtain a mixed solution A;
step 2, adding pearl powder and menthol into the mixed solution A, and dissolving to obtain a mixed solution B;
step 3, dissolving sodium carboxymethylcellulose and polyvinyl alcohol in water to prepare a mixed solution C, and mixing the mixed solution B with the mixed solution C to obtain a mixed solution D;
and 4, adding the poloxamer 407 into the mixed solution D, and uniformly mixing to obtain the composite material.
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| CN115025125B (en) | 2023-09-29 |
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