CN106539751A - A kind of Beclomethasone dipropionate emulsifiable paste and preparation method thereof - Google Patents
A kind of Beclomethasone dipropionate emulsifiable paste and preparation method thereof Download PDFInfo
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- CN106539751A CN106539751A CN201710031677.5A CN201710031677A CN106539751A CN 106539751 A CN106539751 A CN 106539751A CN 201710031677 A CN201710031677 A CN 201710031677A CN 106539751 A CN106539751 A CN 106539751A
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- emulsifiable paste
- beclomethasone dipropionate
- glucose
- sodium acetate
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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
- 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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- 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
- A61K47/02—Inorganic compounds
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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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
Abstract
The invention provides a kind of Beclomethasone dipropionate emulsifiable paste and preparation method thereof, after the peanut oil of rational proportion, talcum powder, glucose, sodium acetate are with the addition of in formula, patient is less prone to erythema, scorching hot these bad reactions after use, improve the adaptability of medication, but obtained Beclomethasone dipropionate emulsifiable paste lotion is uneven, reflecting feel, coating and viscosity are poor, have a large amount of bubbles profit layering, have had a strong impact on its normal use.Jing after special process of the present invention process, the appearance character of Beclomethasone dipropionate emulsifiable paste can be improved, make that lotion uniform and smooth, reflecting feel are strong, coating is good, viscosity is suitable, bubble-free and oil-free water stratification phenomenon.Erythema, scorching hot is less prone to during Beclomethasone dipropionate emulsifiable paste use obtained in of the invention, adverse reactions of patients is few, and lotion appearance character is preferably, stable in properties.
Description
Technical field
The present invention relates to a kind of cream and preparation method thereof, more particularly to a kind of Beclomethasone dipropionate emulsifiable paste and its preparation
Method.
Background technology
The potent external application glucocorticoids medicine of beclomeasone propionate system, with anti-inflammatory, antiallergy and the effect such as antipruritic, can press down
Bronchus exudate processed, eliminates tunica mucosa bronchiorum swelling, releases bronchial spasm, and skin vasoconstriction is acted on can more than hydrogenation
Pine it is strong, local anti-inflammatory effect is 5 times of fluocinolone acetonide and triamcinolone.Lipophilicity is stronger, easily permeates, and is applied to affected part after 30 minutes i.e.
Come into force.
Beclomethasone dipropionate emulsifiable paste is applied to anaphylaxis with inflammatory dermatoses and relevant disease, such as eczema, anaphylaxis skin
Inflammation, contact dermatitis, neurodermatitis, lichen planus, lupus erythematosus discoides, palmoplantar pustulosis, itch, psoriasis etc..But make
Easily cause the bad reaction such as erythema, scorching hot, papule, crust with during.
The content of the invention
It is an object of the invention to provide a kind of Beclomethasone dipropionate emulsifiable paste and preparation method thereof, patient is using the emulsifiable paste
After be less prone to erythema, scorching hot these bad reactions, improve the adaptability of medication, and lotion uniform and smooth, reflecting feel be strong, apply
Cloth is good, viscosity is suitable, bubble-free and profit lamination.
The present invention is achieved through the following technical solutions：
A kind of Beclomethasone dipropionate emulsifiable paste, including the supplementary material of following weight：
Beclomeasone propionate 0.25g, stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g,
Dimethicone 20g, liquid paraffin 60g, ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil 6.5-8.4g,
Talcum powder 0.5-1.1g, glucose 2.2-4.7g, sodium acetate 0.3-0.9g, purified water add to l000g；
Its preparation method is as follows：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin mixing are taken, plus
To 70～80 DEG C, fusing adds peanut oil, stirs, obtains oil phase heat after 20-30min；
2) purified water is heated to into 70～80 DEG C, add ethylparaben, sequentially add after which is completely dissolved glucose,
Sodium acetate, adds glycerine and triethanolamine after glucose, sodium acetate are completely dissolved, stirs, obtain water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, protected
Temperature is held for 70-80 DEG C, talcum powder is added, 40-50min is stirred, is subsequently cooled to room temperature, obtains final product.
After the peanut oil that rational proportion is with the addition of in formula of the invention, talcum powder, glucose, sodium acetate, patient makes
Erythema, scorching hot these bad reactions are less prone to after, the adaptability of medication, but obtained Beclomethasone dipropionate emulsifiable paste is improve
Lotion is uneven, and reflecting feel, coating and viscosity are poor, has a large amount of bubbles profit layering, has had a strong impact on its normal use.
Jing special process of the present invention process after, the appearance character of Beclomethasone dipropionate emulsifiable paste can be improved, make lotion uniform and smooth,
Reflecting feel is strong, coating is good, viscosity is suitable, bubble-free and oil-free water stratification phenomenon.
Erythema, burning heat sensation are less prone to during Beclomethasone dipropionate emulsifiable paste use obtained in of the invention, patient is bad anti-
Should lack, and lotion appearance character is preferably, it is stable in properties.
Specific embodiment
Embodiment 1：A kind of Beclomethasone dipropionate emulsifiable paste, including the supplementary material of following weight：
Beclomeasone propionate 0.25g, stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g,
Dimethicone 20g, liquid paraffin 60g, ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil 7.5g, talcum
Powder 0.8g, glucose 3.4g, sodium acetate 0.6g, purified water add to l000g；
Its preparation method is as follows：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin mixing are taken, plus
To 75 DEG C, fusing adds peanut oil, stirs, obtains oil phase heat after 25min；
2) purified water is heated to into 75 DEG C, adds ethylparaben, glucose, acetic acid are sequentially added after which is completely dissolved
Sodium, adds glycerine and triethanolamine after glucose, sodium acetate are completely dissolved, stirs, obtain water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, protected
Temperature is held for 75 DEG C, talcum powder is added, 45min is stirred, is subsequently cooled to room temperature, obtains final product.
Embodiment 2：A kind of Beclomethasone dipropionate emulsifiable paste, including the supplementary material of following weight：
Beclomeasone propionate 0.25g, stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g,
Dimethicone 20g, liquid paraffin 60g, ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil 6.5g, talcum
Powder 0.5g, glucose 2.2g, sodium acetate 0.3g, purified water add to l000g；
Its preparation method is as follows：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin mixing are taken, plus
To 70 DEG C, fusing adds peanut oil, stirs, obtains oil phase heat after 20min；
2) purified water is heated to into 70 DEG C, adds ethylparaben, glucose, acetic acid are sequentially added after which is completely dissolved
Sodium, adds glycerine and triethanolamine after glucose, sodium acetate are completely dissolved, stirs, obtain water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, protected
Temperature is held for 70 DEG C, talcum powder is added, 40min is stirred, is subsequently cooled to room temperature, obtains final product.
Embodiment 3：A kind of Beclomethasone dipropionate emulsifiable paste, including the supplementary material of following weight：
Beclomeasone propionate 0.25g, stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g,
Dimethicone 20g, liquid paraffin 60g, ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil 8.4g, talcum
Powder 1.1g, glucose 4.7g, sodium acetate 0.9g, purified water add to l000g；
Its preparation method is as follows：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin mixing are taken, plus
To 80 DEG C, fusing adds peanut oil, stirs, obtains oil phase heat after 30min；
2) purified water is heated to into 80 DEG C, adds ethylparaben, glucose, acetic acid are sequentially added after which is completely dissolved
Sodium, adds glycerine and triethanolamine after glucose, sodium acetate are completely dissolved, stirs, obtain water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, protected
Temperature is held for 80 DEG C, talcum powder is added, 50min is stirred, is subsequently cooled to room temperature, obtains final product.
Embodiment 4：A kind of Beclomethasone dipropionate emulsifiable paste, including the supplementary material of following weight：
Beclomeasone propionate 0.25g, stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g,
Dimethicone 20g, liquid paraffin 60g, ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil 6.4g, talcum
Powder 1.2g, glucose 2.0g, sodium acetate 0.1g, purified water add to l000g；
Its preparation method is as follows：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin mixing are taken, plus
To 70 DEG C, fusing adds peanut oil, stirs, obtains oil phase heat after 15min；
2) purified water is heated to into 70 DEG C, adds ethylparaben, glucose, acetic acid are sequentially added after which is completely dissolved
Sodium, adds glycerine and triethanolamine after glucose, sodium acetate are completely dissolved, stirs, obtain water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, protected
Temperature is held for 70 DEG C, talcum powder is added, 55min is stirred, is subsequently cooled to room temperature, obtains final product.
Embodiment 5：A kind of Beclomethasone dipropionate emulsifiable paste, with embodiment 1, its preparation method is as follows for its formula：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin, peanut oil are taken
Mixing, is heated to 80 DEG C, melts, stirs, obtain oil phase；2) purified water is heated to into 80 DEG C, adds ethylparaben, treat
Which adds glucose, sodium acetate, glycerine and triethanolamine after being completely dissolved, and stirs, obtains water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, protected
Temperature is held for 80 DEG C, 35min is stirred, room temperature is subsequently cooled to, talcum powder is added, is stirred evenly, obtain final product.
Comparative example 1：Du Rong, Guo Miaomiao, Xu Dan, Wang Nian, Ji Zhijian, Liu Hui are published in《Chinese pharmacists》2011 volume 14
The piece of 10th phase is entitled《The preparation and its skin sensibiligen experimental study of compound Beclomethasone dipropionate emulsifiable paste》Article in it is public
A kind of compound Beclomethasone dipropionate emulsifiable paste is opened, its preparation method is to take stearic acid 60g, glycerin monostearate 30g, Bai Fanshi
Woods 20g, octadecyl alcolol 10g, dimethicone 20g, light liquid petrolatum 60g mix, and heat in 70～80 DEG C of water-baths, melt
Change, stir, make into oil phase A, ethylparaben 1.2g is dissolved in appropriate boiling distilled water, glycerine 100g, three ethanol are added
Appropriate amine, heats in 70～80 DEG C of water-baths, stirs, make into aqueous phase B.By A phases and B phase suction homogeneous pots, purified water
L000g is added to, 70～80 DEG C of constant temperature homogeneous is kept, after fully emulsified, stirring is simultaneously progressively cooled down.Recipe quantity medicine is weighed separately
(beclomeasone propionate 0.25g, chloramphenicol 10g, borneol 15g), finely ground crushing cross No. 9 sieves, add blank emulsifiable paste matrix, stir evenly,
Compound Beclomethasone dipropionate emulsifiable paste is obtained.
Test example 1：Bad reaction is compared
72 people of eczema patients, age 20-50 year, each 36 people of men and women is selected to be randomly divided into 6 experimental groups, per group of each 12 people,
Each group patient smears embodiment 1-5 and Beclomethasone dipropionate emulsifiable paste obtained in comparative example 1 respectively in affected part, three times a day, continuous to apply
Smear 10 days, the local skin of observation coating whether there is burning heat sensation, red and swollen these bad reactions daily.
As a result:The patient of 5 corresponding experimental group of embodiment 1-3 and embodiment do not occur in 10 days it is any it is scorching hot, red and swollen not
Good reaction；1 corresponding experimental group patient of comparative example have 8 people coating the 2nd day local skin occur it is scorching hot, red and swollen bad
Reaction, has 2 people the sense of discomfort such as scorching hot, red and swollen occurred at the 5th day, and during smearing ointment, the sense of discomfort such as scorching hot, red and swollen have by
The trend for gradually increasing；4 corresponding experimental group patient of embodiment had at the 2nd day 11 people coating local skin occur it is scorching hot,
Red and swollen phenomenon, and degree is serious compared with 1 corresponding experimental group of comparative example.
Test example 2：Appearance character compares
By embodiment 1-5 and obtained in comparative example 1, Beclomethasone dipropionate emulsifiable paste sample is respectively coated on surface plate, observation
Whether there is lamination, if uniformity, the results are shown in Table 1.Ointment uniform and smooth, reflecting feel are strong, coating is good, viscosity is suitable
Preferably, bubble-free and oil-free water stratification phenomenon obtains 5 points；Ointment is uniform, sophistication, reflecting feel, coating and it is sticky still, have a small amount of
Bubble and oil-free water stratification phenomenon obtains 2 points；Ointment is uneven, reflecting feel, and coating and viscosity are poor, has a large amount of bubbles profit
It is layered to obtain 0 point.
1 Beclomethasone dipropionate emulsifiable paste appearance character of table scores
From test example 1 and test example 2, after addition peanut oil, talcum powder, glucose, sodium acetate, patient can be reduced
Occur erythema, the probability of scorching hot these bad reactions after use, improve the adaptability of patient；Described in technical solution of the present invention
Special process can improve the appearance character of Beclomethasone dipropionate emulsifiable paste, make that lotion uniform and smooth, reflecting feel be strong, coating is good, viscous
Denseness is suitable, bubble-free and oil-free water stratification phenomenon.
Claims (5)
1. a kind of Beclomethasone dipropionate emulsifiable paste, it is characterised in that：Including the supplementary material of following weight：Beclomeasone propionate 0.25g,
Stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g, dimethicone 20g, liquid paraffin 60g,
Ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil, talcum powder, glucose, sodium acetate, purified water are added to
l000g；
2. a kind of Beclomethasone dipropionate emulsifiable paste, it is characterised in that：Including the supplementary material of following weight：Beclomeasone propionate 0.25g,
Stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g, dimethicone 20g, liquid paraffin 60g,
Ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil 6.5-8.4g, talcum powder 0.5-1.1g, glucose 2.2-
4.7g, sodium acetate 0.3-0.9g, purified water add to l000g.
3. a kind of Beclomethasone dipropionate emulsifiable paste as claimed in claim 2, it is characterised in that：Including the supplementary material of following weight：
Beclomeasone propionate 0.25g, stearic acid 60g, glycerin monostearate 30g, albolene 20g, octadecyl alcolol 10g, dimethyl-silicon
Oily 20g, liquid paraffin 60g, ethylparaben 1.2g, glycerine 100g, triethanolamine 2g, peanut oil 7.5g, talcum powder 0.8g, Portugal
Grape sugar 3.4g, sodium acetate 0.6g, purified water add to l000g.
4. as claimed in claim 2 or claim 3 a kind of Beclomethasone dipropionate emulsifiable paste, it is characterised in that：Preparation method is as follows：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin mixing are taken, is heated to
70～80 DEG C, fusing adds peanut oil, stirs, obtains oil phase after 20-30min；
2) purified water is heated to into 70～80 DEG C, adds ethylparaben, glucose, acetic acid are sequentially added after which is completely dissolved
Sodium, adds glycerine and triethanolamine after glucose, sodium acetate are completely dissolved, stirs, obtain water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, keep temperature
Spend for 70-80 DEG C, add talcum powder, stir 40-50min, be subsequently cooled to room temperature, obtain final product.
5. a kind of Beclomethasone dipropionate emulsifiable paste as claimed in claim 4, it is characterised in that：Preparation method is as follows：
1) stearic acid, glycerin monostearate, albolene, octadecyl alcolol, dimethicone, liquid paraffin mixing are taken, is heated to
75 DEG C, fusing adds peanut oil, stirs, obtains oil phase after 25min；
2) purified water is heated to into 75 DEG C, adds ethylparaben, glucose, sodium acetate are sequentially added after which is completely dissolved,
Glycerine and triethanolamine are added after glucose, sodium acetate are completely dissolved, is stirred, is obtained water phase；
3) beclomeasone propionate is slowly added in oil phase, oil phase is added slowly in water phase after being well mixed, keep temperature
Spend for 75 DEG C, add talcum powder, stir 45min, be subsequently cooled to room temperature, obtain final product.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115414321A (en) * | 2022-10-20 | 2022-12-02 | 山东新时代药业有限公司 | Beclomethasone dipropionate emulsifiable paste and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528313A (en) * | 2003-09-29 | 2004-09-15 | 中国医学科学院皮肤病研究所 | Complex external medicine for treating psoriasis |
-
2017
- 2017-01-17 CN CN201710031677.5A patent/CN106539751A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528313A (en) * | 2003-09-29 | 2004-09-15 | 中国医学科学院皮肤病研究所 | Complex external medicine for treating psoriasis |
Non-Patent Citations (2)
| Title |
|---|
| 李铮铮等: "丙酸倍氯米松乳膏制备工艺优选及验证", 《医药导报》 * |
| 杜蓉等: "复方丙酸倍氯米松乳膏的制备及其皮肤急性毒性试验研究", 《中国药师》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115414321A (en) * | 2022-10-20 | 2022-12-02 | 山东新时代药业有限公司 | Beclomethasone dipropionate emulsifiable paste and preparation method thereof |
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Application publication date: 20170329 |