CN115025125B - Pharmaceutical composition for treating dental ulcer and preparation method thereof - Google Patents
Pharmaceutical composition for treating dental ulcer and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4453—Non condensed piperidines, e.g. piperocaine only substituted in position 1, e.g. propipocaine, diperodon
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The application belongs to the technical field of ulcer treatment medicines, and particularly relates to a pharmaceutical composition for treating dental ulcer and a preparation method thereof. The pharmaceutical composition comprises the following components in parts by weight: 3.33 to 80 parts of pearl powder, 0.33 to 10 parts of menthol, 0.033 to 4 parts of dexamethasone sodium phosphate and 1.238 to 3.238 parts of dyclonine hydrochloride. The composition provided by the application can produce good analgesic and therapeutic effects on oral ulcer, and the temperature-sensitive gel prepared in the preferred scheme has good stability and good application prospect.
Description
Technical Field
The application belongs to the technical field of ulcer treatment medicines, and particularly relates to a pharmaceutical composition for treating dental ulcer and a preparation method thereof.
Background
Oral erosion is a superficial defect of oral mucosa, which is a partial injury of epithelium without damaging basal cell layers. Dental ulcers are depressions formed by the loss or disruption of the integrity of the oral mucosal epithelium, which is continuously broken, necrotic and sloughed off the surface layer. Various oral mucosa diseases can cause oral mucosa erosion and ulcer, including erosive oral lichen planus, radiotherapy and chemotherapy oral mucositis, recurrent aphtha ulcer, traumatic ulcer and the like. Oral erosion and ulcers are often accompanied by pain of varying degrees, affecting normal physiological functions such as feeding, speech, swallowing, chewing, etc., and the quality of life of the patient. Therefore, the oral mucosa pain is obviously relieved, and the healing of erosion and ulcer is promoted, so that the oral mucosa pain relieving tablet has important clinical significance.
Currently, external medicines are commonly used for treating canker sore. For example, "CN104490920a is a patch for treating dental ulcer and a preparation method thereof", provides a patch for treating dental ulcer, the active ingredients of which mainly include dyclonine hydrochloride, aureomycin hydrochloride, metronidazole, dexamethasone sodium phosphate and the like. However, the existing external medicine still has a plurality of problems, such as easy generation of foreign body sensation in the oral cavity, discomfort, poor treatment effect and difficult effective pain elimination. Thus, there remains a need to develop new treatments for canker sores, providing more options for the treatment of canker sores.
Disclosure of Invention
Aiming at the defects of the prior art, the application provides a pharmaceutical composition for treating canker sore and a preparation method thereof, and aims to provide more choices for the treatment of canker sore.
The pharmaceutical composition for treating the canker sore comprises the following components in parts by weight:
3.33 to 80 parts of pearl powder,
0.33 to 10 portions of menthol,
0.033 to 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 to 36.675 parts of pearl powder,
2.563 to 4.563 portions of menthol,
0.438 to 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 parts of pearl powder,
3.583 portions of menthol,
0.539 part of dexamethasone sodium phosphate,
3.089 parts of dyclonine hydrochloride.
Preferably, the composition comprises a gel and dyclonine hydrochloride solid which are packaged respectively, wherein the gel is obtained by dispersing pearl powder, menthol and dyclonine hydrochloride in poloxamer 407 temperature-sensitive gel.
Preferably, the composition of the gel is as follows:
3.33-80 mg/ml of pearl powder,
Menthol 0.33-10 mg/ml,
Dexamethasone sodium phosphate 0.033-4 mg/ml,
407 160-200 mg/ml poloxamer,
6.67-100 mg/ml of humectant,
The adhesive cement component is 2.33-11.41 mg/ml
The balance being water.
Preferably, it comprises the following components:
16.675-36.675 mg/ml pearl powder,
2.563-4.563 mg/ml menthol,
Dexamethasone sodium phosphate 0.438-0.638 mg/ml,
407 160-200 mg/ml poloxamer,
30-50 mg/ml of humectant,
The adhesive cement component is 2.33-5.56 mg/ml
The balance being water.
Preferably, it comprises the following components:
28.675mg/ml pearl powder,
3.583mg/ml menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
Poloxamer 407.5 mg/ml,
Humectant 42.98mg/ml,
Adhesive component 3.682mg/ml
The balance being water.
Preferably, the humectant is selected from one or two of orange fish liver and glycerin.
Preferably, the glue solution component is selected from one or two of sodium carboxymethyl cellulose and polyvinyl alcohol.
The application also provides a preparation method of the pharmaceutical composition, which comprises the following steps:
step 1, dissolving dexamethasone sodium phosphate in water, and then mixing with orange juice 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 carboxymethyl cellulose and polyvinyl alcohol in water to prepare a mixed solution C, and mixing the mixed solution B and the mixed solution C to obtain a mixed solution D;
and 4, adding poloxamer 407 into the mixed solution D, and uniformly mixing to obtain the compound.
The pharmaceutical composition provided by the application can relieve pain at an ulcer part, promote healing of the ulcer, and has a good treatment effect on oral ulcer. The preferred scheme of the application prepares a pharmaceutical composition which can be stably stored for a long time and has temperature-sensitive property by reasonably optimizing components, wherein the pharmaceutical composition is an aqueous solution at 4 ℃ and is hydrogel at room temperature. Experiments show that the medicine composition can be stably stored for a long time as an aqueous solution or hydrogel only by adopting the component selection and the dosage of the medicine composition. The pharmaceutical composition can be further added with dyclonine hydrochloride to prepare temperature-sensitive hydrogel for treating canker sore, and the temperature-sensitive hydrogel has good treatment and pain relieving effects on canker sore and good application prospect.
It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the application as defined by the appended claims.
The above-described aspects of the present application will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present application is limited to the following examples only. All techniques implemented based on the above description of the application are within the scope of the application.
Drawings
FIG. 1 is a schematic package diagram of example 1;
fig. 2 is a temperature-sensitive property experimental photograph of the temperature-sensitive ulcer gel of example 1;
FIG. 3 is a photograph of the temperature sensitive ulcer gel of example 1 kept stable;
FIG. 4 is a photograph of comparative example 1 failing to form a stable gel;
FIG. 5 is a photograph of comparative example 1 failing to form a stable gel;
fig. 6 is a photograph of comparative example 2 in which a stable gel cannot be formed.
FIG. 7 is a photograph of the temperature sensitive ulcer gel of example 1 applied at the ulcer;
FIG. 8 is a photograph showing the therapeutic results of a treatment experiment of a rat canker sore model in experimental example 1;
FIG. 9 is a comparison of the therapeutic results of the rat canker sore model therapeutic 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 and the pharmaceutical composition are separately packaged by using a dry-wet separation fresh-keeping bottle. As shown in figure 1, the dry-wet separation fresh-keeping bottle consists of an upper part and a lower part, and can realize the simultaneous and separate preservation of solid powder and gel (solution). The powder is stored in the primary and secondary covers at the upper part, and the lower part is used for storing gel (solution), so that the powder is simple and convenient to use, can be opened at any time, and is small and convenient. When in use, the bottle cap is pressed, the powder is released, the bottle cap is shaken forcefully, and the drip tube cap is replaced after the powder is completely dissolved. The reason for the separate packaging is that dyclonine hydrochloride is unstable in the liquid and is easily decomposed. In this example, dyclonine hydrochloride can be added to a pharmaceutical composition in solution form prior to use by packaging in dry and wet separate fresh-keeping bottles.
The pharmaceutical composition of this example comprises:
28.675mg/ml pearl powder,
42.98mg/ml orange juice cod liver oil,
3.583mg/ml menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
Poloxamer 407.5 mg/ml,
2.783mg/ml sodium carboxymethylcellulose,
0.899mg/ml polyvinyl alcohol,
The balance being water.
The pharmaceutical composition is prepared by the following steps: dissolving pearl powder and menthol in 0.11ml of orange juice cod liver oil and 2ml of dexamethasone sodium phosphate solution in a dry-wet separation fresh-keeping bottle through magnetic stirring, then adding 1ml of mucilage (the mucilage is prepared by dissolving sodium carboxymethylcellulose and polyvinyl alcohol in 1ml of triple distilled water, adding solid powder of the two compounds, standing at room temperature, and stirring uniformly with 5ml of P407. In this example, the resulting pharmaceutical composition was an aqueous solution at 4℃and a hydrogel at room temperature. The total volume in the presence of the aqueous solution was 8ml.
The pharmaceutical composition prepared by the method can be stably stored for a long time at room temperature, wherein the pharmaceutical composition after 90 days of storage is shown in figure 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 fresh-keeping bottle is 3.089mg/ml. The temperature-sensitive ulcer gel is an aqueous solution at 4 ℃ and is hydrogel at room temperature. As shown in fig. 3. The temperature-sensitive ulcer gel prepared by the method is kept stable at room temperature, and has no layering or precipitation phenomenon.
Example 2
The composition of this example was prepared and packaged in the same manner as in example 1, and its composition was:
80mg/ml pearl powder,
Orange juice cod liver oil 100mg/ml,
Menthol 10mg/ml,
Dexamethasone sodium phosphate 4mg/ml,
Poloxamer 407 200mg/ml,
6.658mg/ml sodium carboxymethylcellulose,
4.755mg/ml of 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 its composition was:
pearl powder 3.33mg/ml,
6.67mg/ml orange juice cod liver oil,
Menthol 0.33mg/ml,
Dexamethasone sodium phosphate 0.033mg/ml,
Poloxamer 407 160mg/ml,
1.663mg/ml sodium carboxymethylcellulose,
Polyvinyl alcohol 0.668mg/ml
The balance being water.
Comparative example 1
This comparative example increases 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 pearl powder,
133.33mg/ml of glycerol,
Orange juice cod liver oil 42.67mg/ml
Menthol 5.70mg/ml,
1.72mg/ml dexamethasone sodium phosphate,
Poloxamer 407 200mg/ml,
2.783mg/ml sodium carboxymethylcellulose,
0.899mg/ml 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 precipitate at 4℃as shown in FIG. 5.
Comparative example 2
In this comparative example, glycerin was used instead of orange 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 pearl powder,
80mg/ml glycerin,
3.583mg/ml menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
Poloxamer 407.5 mg/ml,
2.783mg/ml sodium carboxymethylcellulose,
0.899mg/ml 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 precipitate at 4℃as shown in FIG. 6.
Comparative example 3
In this comparative example, the same amount of glycerin and orange cod liver oil were simultaneously added, and the 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 pearl powder,
Liver oil 40mg/ml,
42.98mg/ml orange juice cod liver oil,
3.583mg/ml menthol,
Dexamethasone sodium phosphate 0.539mg/ml,
Poloxamer 407.5 mg/ml,
2.783mg/ml sodium carboxymethylcellulose,
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 precipitate at 4℃as shown in FIG. 7.
The beneficial effects of the application are further illustrated by experiments below.
Experimental example 1 therapeutic Effect of temperature-sensitive ulcer gel
The experimental example examines the treatment effect of the temperature-sensitive ulcer gel prepared in example 1
Dropping the temperature sensitive ulcer gel product in liquid form onto the in vitro pig tongue mucous membrane to form hydrogel. The surface of the ulcer on the inner side of the lower lip of the rat is dripped with liquid to form hydrogel immediately. The same effect was also observed on the ulcer surface on the inner side of the lower lip of the human (fig. 7). Meanwhile, within 2 minutes after the product is used, the pain at the ulcer part is completely relieved, the local tingling sensation can last for more than 30 minutes, and the healing of the dental ulcer can be obviously promoted.
The method for constructing the rat canker sore model by using the 50% glacial acetic acid solution comprises the following specific steps: SD male rats (weight about 220 g) were anesthetized by intraperitoneal injection of 10% chloral hydrate (3 mL/kg), fixed on a console, the mucous membrane of the inner side of the lower lip of the rats was wiped dry with sterile cotton balls, the mucous membrane of the inner side of the lower lip of the rats was isolated from moisture, a cotton-like ball with a diameter of 4mm soaked with 50% glacial acetic acid was placed on the mucous membrane of the inner side of the lower lip of the rats after drying, and after holding for 45s, the cotton-like ball was taken out. After modeling for 48 hours, ulcers with "yellow, red, concave" clinical features appear in the mucous membrane in the lower lip as a sign of successful modeling. The rats successfully modeled are randomly divided into two groups, the temperature sensitive ulcer gel is locally used by an experimental group, and triamcinolone acetonide ointment for clinically treating the dental ulcer is used as a control, so that the temperature sensitive gel is found to be capable of remarkably promoting the healing of the dental ulcer of the rats. On the 4 th, 6 th and 8 th days of administration, the healing of the ulcers of the rats treated by the temperature sensitive gel is superior to that of the triamcinolone acetonide ointment treated group (the difference of the sizes of the ulcers is statistically significant, and p is less than 0.05); moreover, on day 8, the temperature sensitive gel group of rat ulcers healed completely, whereas the triamcinolone acetonide ointment group of rat ulcers did not heal completely (fig. 8, 9). Therefore, the temperature-sensitive gel provided by the application has good effect of promoting oral healing.
It can be seen from the above examples and comparative examples that stable temperature-sensitive gels can be formed only by the preferred components of the present application and the amounts thereof. The temperature-sensitive gel prepared by the application can produce good analgesic and therapeutic effects on oral ulcer, and has good application prospect.
Claims (7)
1. A pharmaceutical composition for treating canker sore, which is characterized by comprising 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,
1.238-3.238 parts of dyclonine hydrochloride;
the composition comprises a gel and dyclonine hydrochloride solid which are packaged respectively, wherein the gel is obtained by dispersing pearl powder and menthol in poloxamer 407 temperature-sensitive gel;
the gel comprises the following components:
3.33-80 mg/ml of pearl powder,
Menthol 0.33-10 mg/ml,
Dexamethasone sodium phosphate 0.033-4 mg/ml,
Poloxamer 407-200 mg/ml,
6.67-100 mg/ml of humectant,
The adhesive cement component is 2.33-11.41 mg/ml
The balance being water;
the humectant is selected from orange juice cod liver oil.
2. The pharmaceutical composition according to claim 1, characterized in that it 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 parts of dexamethasone sodium phosphate,
1.238-3.238 parts of dyclonine hydrochloride.
3. The pharmaceutical composition according to claim 1, characterized in that it comprises the following components in parts by weight:
28.675 parts of pearl powder,
3.583 portions of menthol,
0.539 part of dexamethasone sodium phosphate,
3.089 parts of dyclonine hydrochloride.
4. The pharmaceutical composition according to claim 1, wherein the composition of the gel is:
16.675-36.675 mg/ml of pearl powder,
Menthol 2.563-4.563 mg/ml,
Dexamethasone sodium phosphate 0.438-0.638 mg/ml,
Poloxamer 407-200 mg/ml,
30-50 mg/ml of humectant,
The adhesive cement component is 2.33-5.56 mg/ml
The balance being water.
5. The pharmaceutical composition according to claim 4, wherein the composition of the gel is:
28.675mg/ml pearl powder,
Menthol 3.583mg/ml,
Dexamethasone sodium phosphate 0.539,262/ml,
Poloxamer 407.5 mg/ml,
Humectant 42.98mg/ml,
Cement component 3.682mg/ml
The balance being water.
6. A pharmaceutical composition according to claim 1, wherein: the mucilage component is one or a mixture of two of sodium carboxymethyl cellulose and polyvinyl alcohol.
7. A method of preparing a pharmaceutical composition according to any one of claims 1 to 6, comprising the steps of:
step 1, dissolving dexamethasone sodium phosphate in water, and then mixing with orange juice 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 carboxymethyl cellulose and polyvinyl alcohol in water to prepare a mixed solution C, and mixing the mixed solution B and the mixed solution C to obtain a mixed solution D;
and 4, adding poloxamer 407 into the mixed solution D, and uniformly mixing to obtain the compound.
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