1. Ointment: A paste-like external preparation of a suitable consistency which is easily applied to the skin, mucous membranes, or wounds by adding the drug to a suitable base.
2. Cream: An ointment prepared using an emulsion-type base.
3. Paste: An ointment containing a large amount (25-70%) of hygroscopic, astringent powder.
4. Ointment quality requirements:
? Uniform, delicate, applied to the skin without rough feeling.
? Appropriate viscosity, easy to coat without melting.
? No rancidity, no separation of oil and water or stratification, can maintain the intrinsic effect.
? There should be no irritation or other reactions.
• The ointment used for the wound should also be sterile.
Second, the matrix: (bases)
1. Matrix requirements:
? Lubrication is non-irritating, suitable for consistency, easy to apply;
? The nature is stable, and there is no major compatibility change;
? It has water absorption and can absorb wound secretions;
? Does not hinder the normal function of the skin, and has good drug release properties;
? Easy to wash, does not contaminate clothes.
2. Be applicable:
Epidermal thickening, keratinization, cleft palate and other chronic skin lesions or early stages of some infectious skin diseases.
3. species:
(1) oleaginous matrix 1 hydrocarbons:
Vaseline: (soft paraffin)
Properties: Melting point 38-60 ° C, odorless, non-irritating, not rancid, stable in nature.
Applicable: drugs that are unstable in water.
Not applicable: Acute and massive exudate affected area.
Features: Appropriate viscosity.
? Solid paraffin:
Properties: melting point 50-65 ° C.
Uses: Adjust the consistency of the ointment.
? Liquid paraffin:
Nature: Can be mixed with most fatty oils or volatile oils.
Uses: Adjust the consistency of the ointment.
? Silicone:
Properties: Viscosity increases with the increase of molecular weight, colorless and odorless liquid, non-toxic, non-irritating, easy to coat, stable in nature.
Uses: to protect the skin as well as transdermal enhancers.
2 lipids:
? Lanolin:
Properties: light brown yellow viscous semi-solid, melting point 36-42 ° C. It has high water absorption and can absorb about 2 times its weight of water and form a W/O emulsion.
Uses: Used in combination with Vaseline. It can improve the water absorption of Vaseline.
3 oils and fats:
Source: Animal and plant higher fatty acid glycerides and mixtures thereof.
Nature: It is easily decomposed, oxidized and rancid by the influence of temperature, light and oxygen.
(2) Emulsion matrix
Composition: water phase + oil phase + emulsifier for: subacute, chronic, non-exudative skin lesions and pruritus.
Avoid use: erosion, ulcers, blisters and pustules.
1 monovalent soap:
Hydroxide
Sodium borate triethyl propylamine + fatty acid soap (O/W emulsifier)
Increased emulsifying ability of triethanolamine ammonium
Features: O/W emulsion matrix for skin without greasy feeling
Disadvantages: easily damaged by acid, alkali, calcium, magnesium ions or other electrolytes. Avoid with cationic drugs: sulfuric acid
prescription:
Stearic acid 100g
Castor oil 100g
Liquid paraffin 100g
Triethanolamine 8g
Glycerin 40g
Distilled water 452g
Application: Cream 2 Multi-valent soap: (W/O emulsion type matrix)
Calcium, magnesium, zinc, aluminum oxide + fatty acid multivalent soap.
Features: Dissociation is small, hydrophilic is less than monovalent soap, strong lipophilic, HLB<6, easy to form, stable high.
prescription:
Stearic acid 12.5 g
Monostearic acid glyceride 17.0g
Bee wax 5.0g
Ground wax 75.0g
Liquid paraffin 410.0ml
White Vaseline 67.0g
Aluminum bis-stearate 10.0g
Calcium hydroxide 1.0g
Hydroxyethyl ester 1.0g
Distilled water 401.5ml
Method: The oil phase is melted at 85 ° C + water phase (85 ° C) while stirring.
3 fatty alcohol sodium sulfate:
Sodium decyl sulfate:
Properties: Anionic emulsifier, commonly used amount: 0.55~2%, suitable pH value is 6~7, not <4,>8.
Compatibility: often combined with other W/O type emulsifiers. Adding 1.5% to 2% sodium chloride can lose its emulsification.
prescription:
Stearyl alcohol 220 g
Sodium lauryl sulfate 15g
Monostearic acid glyceride 17.0g
White Vaseline 250g
Hydroxymethyl 0.25g
Hydroxypropyl propyl ester 0.15g
Propylene glycol 120 g
Distilled water added to 1000 g
Method: The oil phase is melted at 75 ° C + water phase (75 ° C) while stirring.
4 high-grade fatty alcohols and polyol esters:
? Advanced fatty alcohol:
Melting point Water-soluble use Cetyl alcohol 45~50°C Insoluble in O/W emulsion matrix, increasing stability and viscosity Octadecyl alcohol 56~60°C Insoluble can increase Vaseline water absorption
? Sodium lauryl sulfate
Uses: O / W emulsion emulsifier dosage: 0.5% ~ 2%
Irritating: smaller
HLB value: 40
Compatibility: It can be compatible with acid-base drugs, Ca and Mg ions, and avoids cationic drug ligands.
5 polyoxyethylene ether derivatives (3) water-soluble matrix:
Features: release drug faster, no greasy feeling, easy to spread, no irritation, can absorb tissue exudate.
Uses: It is used for moisturizing, smashing wounds, facilitating the elimination of secretions, and also for the matrix of mucosal mucosa or oil-proof protective ointment.
Disadvantages: poor lubrication, where water is easy to evaporate and mildew.
? Glycerin gelatin:
Method: gelatin 1~3% + glycerol 10~30% + finished water.
Features: Form a layer of protective end, teach comfort when using.
? Cellulose derivatives:
MC: Soluble in cold water.
CMC: It is hot and cold, and its CMC-Na and heavy metal ions cannot be liganded.
? PEG class:
Common molecular weight: 300~6000
Liquid waxy solid
Features: Soluble in water, easy to exudate mixed and easy to wash, stable in nature, not easy to mold.
Third, the preparation and examples of ointments
1. Method of drug addition:
1 Substrate soluble in the drug: oil-soluble drug oil phase; water-soluble drug aqueous phase.
2 Insoluble drugs: The drug is pulverized into fine powder (paste) and mixed evenly.
3 low-dose drugs: equal amount of addition.
4 Semi-solid viscous drug: mixed directly with the matrix + lanolin + Vaseline 5 Coexistence of volatile, eutectic components: directly mixed with the matrix.
6 oxidative hydrolysis drugs:
2. Preparation:
1 Research and method: semi-solid + liquid
Drug + part of the matrix (or liquid) fine paste to add the remaining matrix
Check for no graininess.
2 fusion method: matrix matrix with higher melting point, melt filtration + drug mixture and condensation
3 emulsification method:
Oil-soluble matrix melting filter
Water soluble drug + aqueous solution heating (80 ° C)
+ drug agitation condensation
3. Example: (376 pages)
Zinc Oxide Ointment:
Zinc oxide 15g
Vaseline 85g
Method: Take zinc oxide in the mortar, add a little Vaseline, and slowly add the remaining Vaseline.
Usage and Dosage: topical, skin astringent.
Fourth, the quality assessment of ointment:
1. Determination of the content of the main drug:
2. Determination of physical properties: melting point, pH, physical appearance, viscosity.
3. Irritating:
4. Stable type:
5. Determination of drug release, penetration and absorption:
5. Packaging and storage of ointment:
1. Packing: ointment tube (tin, aluminum, plastic); plastic box.
2. Packaging equipment: automatic device. Rolling tail, boxing linkage.
3. Storage: Keep away from light and cool, and the temperature should not be too high or too low.
Six, paste:
1. Concept: A topical semi-solid preparation containing more than 25% solid drug.
2. Function characteristics: by convergence, anti-inflammatory, absorption of secretions and so on.
3. Uses: subacute and chronic inflammation.
4. Example:
Gentian violet gentian violet paste 1g
Glycerin 10ml
Zinc oxide 15g
Starch 15g
Anhydrous lanolin 20g
Vaseline 100g
Method: lanolin + Vaseline melting (about 60 ° C)
Zinc oxide starch sieving + gentian violet glycerol solution is stirred without water droplets condensed into a paste.
Seven, tincture:
1. Concept: A soft mud-like preparation prepared by mixing a main drug with an excipient, and not sloping the container so as not to flow out.
2. Excipients: flour, starch, licorice powder, linseed powder, syrup, vegetable oil, etc.
3. Method: Mix the fine powder in the main medicine container and mix it with a small amount of water.
Add excipients and appropriate amount of liquid to make a uniform paste.
4. Usage: Oral
5. Example:
Antidiarrheal prescription bismuth nitrate 20g
Capric acid protein 10g
Starch and water amount Usage and use: Horse once sputum, treatment of diarrhea.
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