CN112716886B - Dexamethasone acetate emulsifiable paste and preparation method thereof - Google Patents
Dexamethasone acetate emulsifiable paste and preparation method thereof Download PDFInfo
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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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- A61K35/60—Fish, e.g. seahorses; Fish eggs
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/535—Perilla (beefsteak plant)
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention discloses dexamethasone acetate emulsifiable paste and a preparation method thereof. Compared with the prior art, the invention enhances the antibacterial property, the moistening property and the stability of the dexamethasone acetate, and leads the content of the dexamethasone acetate cream to be stable and the antibacterial property to be strong.
Description
Technical Field
The invention belongs to an ointment and a preparation method thereof, in particular to a dexamethasone acetate cream and a preparation method thereof.
Background
Dexamethasone acetate ointment is a standard collection variety of the sanitary department edition, but the antibacterial property, the stability and the like of the dexamethasone acetate ointment are reduced after the dexamethasone acetate ointment is placed for a long time, so that the company carries out research again on the basis of the previous triamcinolone acetonide acetate ointment research, and the stability, the antibacterial property and the like are further improved to meet the requirements of the sanitary department edition.
Disclosure of Invention
The invention aims to solve the 1 st technical problem of providing the dexamethasone acetate cream with good antibacterial property and stability.
The 2 nd technical problem to be solved by the invention is a preparation method of the cream.
The technical scheme for solving the technical problem of the invention is as follows: a dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid, citric acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 0.5-1: 0.5-1: 0.5-1: 0.5 to 1;
the weight ratio of the poly-gamma-glutamic acid to the citric acid to the sodium caprylate is 1: 0.3-0.8: 0.3-0.8.
The weight ratio of the poly-gamma-glutamic acid to the sodium caprylate is 1: 0.5-0.8.
The preparation method of the dexamethasone acetate cream comprises the following steps:
1) water phase: putting purified water into a water phase pretreatment pot, adding glycerol, mixing and stirring uniformly, then adding poly-gamma-glutamic acid, citric acid and sodium caprylate, and stirring and mixing uniformly for later use;
2) oil phase: putting weighed stearic acid into an oil phase pretreatment pot, pumping white vaseline and light liquid paraffin into the oil phase pretreatment pot, heating, stirring, melting, keeping the temperature at 100 ℃ for 30 minutes, cooling to 60 ℃, and preserving heat;
3) mixing dexamethasone acetate, folium Perillae extract, and clear cod liver oil, stirring for dissolving, slowly adding into oil phase, and stirring;
4) slowly adding the water phase into the oil phase obtained in the step 3), stirring the mixture in the forward direction while adding the water phase until the mixture is completely mixed, then cooling the mixture to room temperature, homogenizing the mixture at 2000 rpm for 15 minutes, and obtaining the product.
Compared with the prior art, the invention enhances the stability of the dexamethasone acetate by adding the comprehensive effects of the antibacterial component, the stabilizing component and the like, so that the antibacterial property, the stability and the like of the dexamethasone acetate cream are kept stable in the shelf life.
Detailed Description
The present invention will be described in detail with reference to examples.
The dexamethasone acetate, the cod-liver oil, the perilla leaf extract, the stearic acid, the white vaseline, the light liquid paraffin, the glycerol, the poly-gamma-glutamic acid, the citric acid, the sodium caprylate and the purified water all accord with corresponding medicinal standards.
Example 1
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid, citric acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 0.8: 0.6: 0.8: 0.8;
the weight ratio of the poly-gamma-glutamic acid to the citric acid to the sodium caprylate is 1: 0.5: 0.5.
the preparation method of the dexamethasone acetate cream comprises the following steps:
1) water phase: putting purified water into a water phase pretreatment pot, adding glycerol, mixing and stirring uniformly, then adding poly-gamma-glutamic acid, citric acid and sodium caprylate, stirring and mixing uniformly for later use;
2) oil phase: putting weighed stearic acid into an oil phase pretreatment pot, pumping white vaseline and light liquid paraffin into the oil phase pretreatment pot, heating, stirring, melting, keeping the temperature at 100 ℃ for 30 minutes, cooling to 60 ℃, and preserving heat;
3) mixing dexamethasone acetate, folium Perillae extract, and clear cod liver oil, stirring for dissolving, slowly adding into oil phase, and stirring;
4) slowly adding the water phase into the oil phase obtained in the step 3), stirring in the forward direction while adding until the water phase is completely mixed, then cooling to room temperature, homogenizing at the speed of 2000 r/min for 15 min, and thus obtaining the product.
Example 2
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid, citric acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1;
the weight ratio of the poly-gamma-glutamic acid to the citric acid to the sodium caprylate is 1: 0.5: 0.5.
the preparation method of the dexamethasone acetate cream comprises the following steps:
1) water phase: putting purified water into a water phase pretreatment pot, adding glycerol, mixing and stirring uniformly, then adding poly-gamma-glutamic acid, citric acid and sodium caprylate, and stirring and mixing uniformly for later use;
2) oil phase: putting weighed stearic acid into an oil phase pretreatment pot, pumping white vaseline and light liquid paraffin into the oil phase pretreatment pot, heating, stirring, melting, keeping the temperature at 100 ℃ for 30 minutes, cooling to 60 ℃, and preserving heat;
3) mixing dexamethasone acetate, folium Perillae extract, and cod liver oil, stirring for dissolving, and slowly adding into oil phase, and stirring;
4) slowly adding the water phase into the oil phase obtained in the step 3), stirring the mixture in the forward direction while adding the water phase until the mixture is completely mixed, then cooling the mixture to room temperature, homogenizing the mixture at 2000 rpm for 15 minutes, and obtaining the product.
Example 3
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid, citric acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 0.8: 0.6: 0.8: 0.8;
the weight ratio of the poly-gamma-glutamic acid to the citric acid to the sodium caprylate is 1: 0.5: 0.5.
the preparation method of the dexamethasone acetate cream comprises the following steps:
1) water phase: putting purified water into a water phase pretreatment pot, adding glycerol, mixing and stirring uniformly, then adding poly-gamma-glutamic acid, citric acid and sodium caprylate, stirring and mixing uniformly for later use;
2) oil phase: putting weighed stearic acid into an oil phase pretreatment pot, pumping white vaseline and light liquid paraffin into the oil phase pretreatment pot, heating, stirring, melting, keeping the temperature at 100 ℃ for 30 minutes, cooling to 60 ℃, and preserving heat;
3) mixing dexamethasone acetate, folium Perillae extract, and clear cod liver oil, stirring for dissolving, slowly adding into oil phase, and stirring;
4) slowly adding the water phase into the oil phase obtained in the step 3), stirring the mixture in the forward direction while adding the water phase until the mixture is completely mixed, then cooling the mixture to room temperature, homogenizing the mixture at 2000 rpm for 15 minutes, and obtaining the product.
Example 4
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid, citric acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1;
the weight ratio of the poly-gamma-glutamic acid to the citric acid to the sodium caprylate is 1: 0.8: 0.8.
the preparation method of the dexamethasone acetate cream comprises the following steps:
1) water phase: putting purified water into a water phase pretreatment pot, adding glycerol, mixing and stirring uniformly, then adding poly-gamma-glutamic acid, citric acid and sodium caprylate, stirring and mixing uniformly for later use;
2) oil phase: putting weighed stearic acid into an oil phase pretreatment pot, pumping white vaseline and light liquid paraffin into the oil phase pretreatment pot, heating, stirring, melting, keeping the temperature at 100 ℃ for 30 minutes, cooling to 60 ℃, and preserving heat;
3) mixing dexamethasone acetate, folium Perillae extract, and clear cod liver oil, stirring for dissolving, slowly adding into oil phase, and stirring;
4) slowly adding the water phase into the oil phase obtained in the step 3), stirring the mixture in the forward direction while adding the water phase until the mixture is completely mixed, then cooling the mixture to room temperature, homogenizing the mixture at 2000 rpm for 15 minutes, and obtaining the product.
Example 5
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid and citric acid;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1;
the weight ratio of the poly-gamma-glutamic acid to the citric acid is 1: 0.8.
example 6
A dexamethasone acetate cream comprises dexamethasone acetate, cod liver oil, folium Perillae extract, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1;
the weight ratio of the poly-gamma-glutamic acid to the sodium caprylate is 1: 0.8.
example 7
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of citric acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1;
the weight ratio of the citric acid to the sodium caprylate is 0.8: 0.8.
example 8
A dexamethasone acetate cream comprises dexamethasone acetate, cod liver oil, folium Perillae extract, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is poly-gamma-glutamic acid;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1.
example 9
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizing agent is citric acid;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1.
example 10
A dexamethasone acetate cream comprises dexamethasone acetate, cod liver oil, folium Perillae extract, ointment and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1.
example 11
A dexamethasone acetate cream comprises dexamethasone acetate, folium Perillae extract, cod liver oil and ointment;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 1: 1: 1: 1.
effects of the invention
Stability examination is carried out on examples 1 to 11 according to the requirements of the stability test of the traditional Chinese medicine in the appendix of the Chinese pharmacopoeia 2010 edition, and the detection method is carried out according to the standard of the ministry of health (WS1-282(D-41) -88). The results are shown in table 1:
the contents in table 1 are all indicated (%) for dexamethasone acetate.
| Month 0 | 6 month | 12 month | 18 month | 24 months | |
| Example 1 | 99.8 | 99.4 | 99.2 | 98.8 | 98.5 |
| Example 2 | 99.7 | 99.4 | 99.1 | 98.8 | 98.6 |
| Example 3 | 99.6 | 99.2 | 98.9 | 98.6 | 98.1 |
| Example 4 | 99.8 | 99.5 | 99.2 | 99.0 | 98.7 |
| Example 5 | 99.5 | 98.3 | 96.4 | 92.6 | 88.7 |
| Example 6 | 99.7 | 98.7 | 94.9 | 90.2 | 87.5 |
| Example 7 | 99.6 | 98.4 | 95.8 | 92.1 | 88.4 |
| Example 8 | 99.8 | 95.2 | 90.6 | 87.1 | 82.4 |
| Example 9 | 99.6 | 93.1 | 89.2 | 85.4 | 81.1 |
| Example 10 | 99.7 | 93.3 | 89.4 | 86.7. | 82.2 |
| Example 11 | 99.5 | 90.4 | 85.6 | 80.1 | 72.7 |
The drugs of examples 1 to 4 were examined for the measurement of the limit of lead, arsenic and mercury, and the detection method was carried out according to the standard (GB 27951). The results were as follows: lead <40mg/kg, arsenic <10mg/kg, mercury <1 mg/kg.
The bactericidal effect of the drugs of examples 1 to 4 was examined, and the test method was carried out according to the standard (GB 15979).
TABLE 2 germicidal Effect requirements
Claims (2)
1. Dessertib acetate cream, characterized in that: consists of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer;
the paste comprises stearic acid, white vaseline, light liquid paraffin, glycerol and purified water;
the stabilizer is a mixture of poly-gamma-glutamic acid, citric acid and sodium caprylate;
the weight ratio of dexamethasone acetate, perilla leaf extract, cod liver oil, paste and stabilizer is 1: 0.5-1: 0.5-1: 0.5-1: 0.5 to 1;
the weight ratio of the poly-gamma-glutamic acid to the citric acid to the sodium caprylate is 1: 0.5-0.8: 0.5-0.8.
2. The method for preparing dexamethasone acetate cream as claimed in claim 1, characterized in that it comprises the following steps:
1) water phase: putting purified water into a water phase pretreatment pot, adding glycerol, mixing and stirring uniformly, then adding poly-gamma-glutamic acid, citric acid and sodium caprylate, stirring and mixing uniformly for later use;
2) oil phase: putting weighed stearic acid into an oil phase pretreatment pot, pumping white vaseline and light liquid paraffin into the oil phase pretreatment pot, heating, stirring, melting, keeping the temperature at 100 ℃ for 30 minutes, cooling to 60 ℃, and preserving heat;
3) mixing dexamethasone acetate, folium Perillae extract, and clear cod liver oil, stirring for dissolving, slowly adding into oil phase, and stirring;
4) slowly adding the water phase into the oil phase obtained in the step 3), stirring the mixture in the forward direction while adding the water phase until the mixture is completely mixed, then cooling the mixture to room temperature, homogenizing the mixture at 2000 rpm for 15 minutes, and obtaining the product.
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| CN101151038A (en) * | 2005-04-04 | 2008-03-26 | 眼力健有限公司 | Stable ophthalmic oil-in-water emulsions with sodium hyaluronate for alleviating dry eye |
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| EP3456314A1 (en) * | 2017-09-14 | 2019-03-20 | Tiofarma B.V. | Topical formulation comprising 17-ketolic corticosteroid |
| CN111184688A (en) * | 2020-03-10 | 2020-05-22 | 成都天台山制药有限公司 | Dexamethasone acetate injection and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP3530711B1 (en) * | 2016-10-24 | 2022-08-17 | Ajinomoto Co., Inc. | Gel composition |
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| JPS61118315A (en) * | 1984-11-13 | 1986-06-05 | Hokuriku Seiyaku Co Ltd | Steroid-17-monoester-containing cream agent |
| JPS62138432A (en) * | 1985-12-12 | 1987-06-22 | Shionogi & Co Ltd | Stable tablet containing anti-inflammatory steroid |
| CN101151038A (en) * | 2005-04-04 | 2008-03-26 | 眼力健有限公司 | Stable ophthalmic oil-in-water emulsions with sodium hyaluronate for alleviating dry eye |
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| CN105616426A (en) * | 2015-07-09 | 2016-06-01 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | Compound dexamethasone acetate nano-cream and preparation method therefor |
| EP3456314A1 (en) * | 2017-09-14 | 2019-03-20 | Tiofarma B.V. | Topical formulation comprising 17-ketolic corticosteroid |
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