Test Center 1. Patch
1. Skeleton material
Such as hydrophobic polysiloxane, hydrophilic polyvinyl alcohol
2. Controlled release film material
(1) The polymer materials used as homogeneous membranes are:
Ethylene-vinyl acetate copolymer, polysiloxane, etc.
(2) Polymer materials used as microporous membranes are:
Polypropylene stretch microporous membrane, etc.
3. Pressure sensitive adhesive
Polyisobutene, polyacrylic acid, silicone rubber
4. Backing materials, anti-stick materials and drug store materials
(1) Backing materials: multi-layer composite aluminum foil, polydiethyl terephthalate, high-density polyethylene, polystyrene, etc
(2) Anti-stick materials: polyethylene, polystyrene, polypropylene, etc.
(3) Drug library materials: carbomer, hypromellose (HPMC), polyvinyl alcohol (PVA), etc
Test center 2. Liquid preparation for skin administration
1. Liniment
A liniment is a liquid preparation made of ethanol, oil or suitable solvent for rubbing the skin without breakage
2. Coating
Refers to a water-based or oily solution, emulsion, suspension containing apies of raw materials, for use before use with disinfectant gauze or cotton balls and other soft materials dipped in the skin or oral and laryngeal mucosa of the liquid preparation
3. Film coating agent
Refers to the active pharmaceutical ingredient dissolved or dispersed in a solvent containing a membrane material, coated with the affected area to form a film of external liquid preparations
4. Lotion
Liquid preparation for cleaning or applying non-broken skin or cavities
Formula:
The liniment should be rubbed and the coating should be made of cotton yarn. Coated into a film, lotion cavity brush.
Test center 3. Aerosol
1. Quality requirements of aerosol
(1) The projectile agent is a suitable low boiling point liquid;
(2) Aerosols for burns, wounds and ulcers should be sterile;
(3) The aerosol should be stored in a cool and dark place to avoid exposure, heat and impact.
2. Ejection agent of aerosol
(1) Hydrofluoroalkaffes
Mainly HFA-134a (tetrafluoroethane) and HFA-227 (heptafluoropropane)
Most of the inhalation aerosols currently marketed worldwide are ejectionants of hydrofluoroalkanes
(2) Hydrocarbons: propane, n-butane and isobutane
(3) Compressed gases: carbon dioxide, nitrogen, nitric oxide, etc
Test center 4.Ophthalmic preparations
1. Quality requirements for ophthalmic preparations
Eye drops, eyewashes and intraocular injection solutions should be isotonic with tears;
Multi-dose ophthalmic preparations should generally be added to appropriate bacteriostatic agents;
The filling amount of eye drops per container shall not exceed 10ml;
The amount of eyewash per container should not exceed 200ml;
Ophthalmic preparations should be stored tightly protected from light and can be used for up to 4 weeks after activation.
2. Additional agent for adjusting pH
Phosphate buffer, boric acid buffer, borate buffer
3. Additional agent for regulating osmotic pressure
Sodium chloride, glucose, boric acid, borax, etc
4. Bacteriostatic agent
Trichloro-tert-butanol, mixture of methylparaben and propyl ester, benzohydroxylamine chloride, phenylmercury nitrate, thiomersal
5. Additional agent to adjust viscosity
Methylcellulose, polyethylene glycol, povidone, polyvinyl alcohol, etc
Test center 5. Suppositories
1. The oily matrix of the suppository
Natural: Cocoa soy fat.
Semi-synthetic or fully synthetic: cocoate, palmitate, mixed fatty acid glycerides.
2. Suppository water-soluble matrix
Glycerol gelatin;
Polyethylene glycol (PEG) :P EG1000, 4000, 6000;
Polosham.
3. Additives
(1) Surfactants
(2) Antioxidants: tert-Butyl hydroxyanisole (BHA), 2,6-di-tert-butyl-p-methylphenol (BHT), gallates, etc
(3) Preservative: paraben
(4) Hardening agents: such as white wax, cetyl alcohol, stearic acid, carnauba wax, etc
(5) Thickener: hydrogenated castor oil, monostearate glycerides, aluminum stearate, etc
(6) Absorption accelerator: non-ionic surfactants, etc