First, the English abbreviation of auxiliary materials
MC: Methyl cellulose
EC: ethyl cellulose
HPC: hydroxypropyl cellulose
HPMC: hydroxypropyl methylcellulose
CAP: Cellulose acetate phthalates
HPMCP: hydroxypropyl cellulose phthalates
HPMCAS: hydroxypropyl methyl cellulose acetate succinate
Cmc-na: Sodium carboxymethyl cellulose
MCC: Microcrystalline cellulose
PVP: Povidone
PEG: polyethylene glycol
PVA: Polyvinyl alcohol
Cms-na: Sodium carboxymethyl starch
PVPP: Cross-linked povidone
CCNa: crosslinked sodium carboxymethyl cellulose
Two, the use of some auxiliary materials
1. Lactose: tablet: filler, especially powder direct tablet filler; Injection: lyophilized protectant
2. Microcrystalline cellulose: tablet: powder directly pressed tablet filler; “Dry adhesive”; Tablets containing 20% microcrystalline cellulose act as disintegrators
3. Methyl cellulose: tablet: adhesive; Suspension agent: suspension aid; Slow (controlled) release preparation: hydrophilic gel skeleton material (weak)
4 sodium carboxymethyl cellulose: tablets: adhesive; Suspension agent: suspension aid; Slow (controlled) release preparation: hydrophilic gel skeleton material
5. Ethyl cellulose: tablet: adhesive (insoluble in water); Slow (controlled) release preparation: skeleton material or membrane controlled material; Solid dispersion: insoluble carrier material
6 hydroxypropyl cellulose: tablet: adhesive, film coating material; Suspension agent: suspension aid; Slow (controlled) release preparation: hydrophilic gel skeleton material, microporous membrane coated sheet pore-inducing agent
7. Hydroxypropyl methyl cellulose (hydroxypropyl methyl cellulose) : tablet: adhesive, film coating material; Suspension agent: suspension aid; Slow and controlled release preparation: hydrophilic gel skeleton material, microporous membrane coated sheet pore-inducing agent
8. Cellulose acetate phthalates: enteric material
9. Hydroxypropyl cellulose phthalates: enteric material
10. Hydroxypropyl cellulose acetate succinate: enteric material
11. Polyvinyl phthalate (PVAP) : enteric material
12. Styrene Maleic acid copolymer (StyMA) : intestinal soluble material
13. Acrylic resin (enteric type I, II, III), Eudragit L, Eudragit S (sometimes Eudragit L100 or Eudragit S 100) : enteric material
14.Eudragit RL, Eudragit RS: : Insoluble carrier material
15.Eudragit E (equivalent to acrylic IV) : gastric soluble polymer material
16. Cellulose acetate: water insoluble material, can be used for coating or preparation of osmotic pump tablets
17. Polyvinylpyrrolidone (povidone PVP) : tablets: adhesives; Tablet: gastric soluble film coating material; Pellets: nifedipine pellets (solid dispersion); Suspension agent: suspension aid;
Solid dispersion: water-soluble carrier material; Slow (controlled) release preparation: hydrophilic colloid skeleton material; Slow (controlled) release preparation: pore-inducing agent in microporous membrane coated tablets
18. Polyvinyl alcohol: film agent: film forming material, suspension aid
19. Sodium carboxymethyl starch: tablet: disintegrating agent
20. Cross-linked povidone: Tablet: disintegrant
21. Crosslinked sodium carboxymethyl cellulose: tablet: disintegrating agent
22. Low-substituted hydroxypropyl cellulose: Tablet: disintegrant
23. Polylactic acid: biodegradable polymer material, used for the preparation of microspheres, nanoparticles, etc
24. Glycerol (sorbitol propylene glycol acts more closely to glycerol)
Liquid preparations: solvent, injection solvent, suspension aid, moisturizer
Plasticizer in capsule and coating material
Ointments, transdermal delivery systems: penetration promoters
Increase the wettability of hydrophobic drugs, osmotic pressure regulator in intravenous fat emulsion
Glycerin gelatin (for ointments, suppositories, solid dispersions)
25. Glycerin gelatin
Dropping pills: water-soluble matrix
Suppository: water-soluble matrix
Ointment: Water soluble matrix
26. Sodium dodecyl sulfate (anionic surfactant)
Emulsions, ointments: emulsifiers
Wetting agent for solid preparations/lubricant for tablets
solubilizer
27. Polyethylene glycol (PEG)
Tablets: Water-soluble lubricant (PEG 4000, 6000)
Tablet: Plasticizer in film coating prescription
Capsule: Soft capsule non-oily liquid medium (PEG 400)
Dropping pills: Water-soluble matrix (PEG 4000, 6000,9300)
Suppository: suppository matrix
Aerosol: Latent solvent (PEG 400, 600)
Injection: Solvent (PEG 400, 600)
Liquid preparation: Solvent (PEG 400, 600)
Solid dispersion: carrier
Slow (controlled) release preparation: pore-inducing agent in microporous membrane coated tablets
Percutaneous absorption preparation: transdermal absorption enhancer
28. Poloxam (” zwitterionic “surfactant) A careful comrade noticed a discrepancy here, now corrected to” Poloxam “non-ionic surfactant, not zwitterionic surfactant!
Solid dispersion carrier, suppository matrix, emulsifier for injection or infusion
A summary of antiseptic and bacteriostatic agents
Hydroxyl benzene ester (neper gold), benzoic acid, sodium benzoate, sorbic acid, benzalkonium bromide (new clean out), benzalkonium chloride (jie er die), chlorhexidine acetate, benzyl alcohol (local pain) at the same time, cross-linked with tertiary butyl alcohol (local pain) at the same time, nitrobenzene, mercury, thimerosal, disinfection net, ortho-phenyl phenol, phenoxyethanol, eucalyptus oil, cinnamon oil, peppermint oil, etc.
Four, sterilization method
1/ Glucose injection, fat emulsion for intravenous injection, dextran, sodium chloride infusion, rubber plug and other hot pressing sterilization;
2/ Vitamin C injection, procaine hydrochloride injection, cortisone acetate injection, chloramphenicol eye drops were sterilized by circulating steam;
3/ Injection oil, grease matrix, ampoule using dry heat sterilization method;
4/ Asepsis room air, operating table surface: ultraviolet sterilization method or gas fumigation method;
5/ Hand, aseptic equipment: chemical sterilization method
6/ Insulin injection and other biological products: filtration sterilization method
V. Related equations
1. Noyes-whitney equation: describes the dissolution rate of solid drugs.
2. Critical relative humidity of the mixture 
hygroscopicity of P68 powder)
3. Replacement price suppository P87)
4.Poiseuile formula: describe the influencing factors of filtration (injection P124)
5. Calculation formula of isotonic regulation by freezing point lowering method injection P156)
6. Calculation of HLB value of mixed surfactant liquid P178)
Relevant preparation technology
1. Microcapsule: condensation method (single, complex), solvent-non-solvent method, changing temperature method, liquid drying method, spray drying method, spray condensation method, air suspension method, interface condensation method, radiation crosslinking method
2. Inclusion compound: saturated aqueous solution method, grinding method, freeze drying method, spray drying method
3. Solid dispersions: melting method, solvent method, solvent – melting method, solvent – spray drying method, grinding method
4. Liposomes: injection method, thin film dispersion method, ultrasonic dispersion method, reverse phase evaporation method, freeze drying method
5. Microspheres: emulsification – curing method, spray drying method, liquid drying method
6. Nanoparticles: micellar polymerization, emulsion polymerization, interfacial polymerization, liquid drying method
7. Pellet: boiling granulation method, spray granulation method, coating pot method, extrusion sphericity method, centrifugal projectile method, liquid drying method
8 suppository: hot melt method, cold pressing method, kneading method
9. Ointment: grinding method, melting method, emulsification method
10 film agent: homogenized slurry flow film forming method, pressure-melting film forming method, composite film making method
Seven, representative accessories
1. Microcapsule: gelatin – Arabic gum
2. Inclusion compound: cyclodextrin
3. Solid dispersion: PEG, PVP
4. Liposomes: phospholipid-cholesterol
5. Microspheres: gelatin, albumin, PLA, etc
6. Suppository: cocoa butter
7. Ointment: Petroleum jelly, etc
8 film agent: PVA
Eight, a few time
1. The sterilized ampoule shall be left for no more than 24 hours;
2. Storage of water for injection shall not exceed 12 hours;
3. Sterilization of general injections shall be completed within 12 hours after potting;
4. Infusion and solution preparation shall be completed within 4 hours of sterilization
9. Quality inspection items related to pharmaceutical preparations
1. Tablets: appearance characteristics; Slice weight difference; Hardness and brittleness; Disintegrating degree; Dissolution or release; Uniformity of content
2. Dispersing agent: uniformity; Moisture. Loading quantity difference; Health examination; Granularity inspection
3. Granule: appearance; Particle size; Dry weight loss; Melt; The load difference
4. Capsule: appearance; Moisture. Loading quantity difference; Disintegration and dissolution.
5. Dropping pills: weight difference; Dissolution time limit inspection, etc.
6. Suppository: appearance; Difference in weight; Melting time limit; Melting point range; In vitro dissolution test and in vivo absorption test
7. Plaster: particle size; The load; Microbial limit; Main drug content; Physical properties; Stimulus; Stability; Release, penetration and absorption of drugs in ointment.
8. Transdermal patches: weight difference; Area difference; Uniformity of content; Release degree, etc.
10. Different definitions
1. Micro capsule: it is a tiny capsule formed by wrapping a solid or liquid drug (called capsule core) in a natural or synthetic polymer material (called capsule material). 1-5000 microns
2. Pellet: refers to the spherical entity with a diameter less than 2.5mm composed of drugs and excipients.
3. Microsphere: a skeleton-type microscopic spherical entity formed by dissolving or dispersive drugs in the framework of polymer materials, with a particle size usually between 1 and 250μm.
4. Nanoparticles: solid colloidal particles composed of polymeric substances, with particle size in the range of 10 ~ 1000nm.
5. Dropping pill agent: refers to solid or liquid drugs and appropriate substances (generally known as matrix) heating melting mix, drop into miscible condensate, contraction condensation and made of small pellet preparation.
Post time: Sep-09-2022