1. Definition and classification: refers to sterile solutions, emulsions or suspensions made of drugs injected into the body, as well as sterile powders or concentrated solutions prepared into solutions or suspensions before use.

Classification by decentralized system:

1, solution injection

2. Suspension injection

3. Opaque injection

4. Sterile powder for injection

Second, the characteristics of injection: rapid and reliable action, suitable for patients who are not suitable for oral administration, and play a local positioning role.

Three. Quality requirements of Kyrgyzstan for injection:

1, sterile

2, no pyrogen

Step 3 be clear

4. Safety

5. ph value: 4-9;

6. Osmotic pressure

Four. Administration route by injection:

1, vein

2. Spinal cavity

3. muscular

4, subcutaneous 1-2ml

5, intradermal

Solvents and additives for injection

1. Water for injection: According to the pharmacopoeia, the water obtained by redistilling distilled water or deionized water has no pyrogen. Endotoxin < 0.5eu, ph 5.0-7.0.

Pyrogen: Endotoxin produced by microorganisms is a compound composed of phosphate, lipopolysaccharide and protein. Lipopolysaccharide has strong pyrogen activity.

1, high temperature injury

Step 2 be adsorbed

Step 3 filter

4, non-volatile

5. Damaged by strong acid, strong alkali and strong oxidant.

Preparation method of wat for injection:

1. distillation method: the legal method in China is to use distilled water or deionized water once, that is, purified water. Small-scale production: tower distiller; Mass production: multi-effect distiller

2. Reverse osmosis: simple equipment, saving energy and cooling water. Included in the United States Pharmacopoeia.

2. Oil for injection: Sesame oil, soybean oil and tea oil should be protected from light. It should be odorless and rancid, its color should not be darker than that of Huang 6, and it should be clear at 10℃. Meet the iodine value, acid value and deterioration value.

Three. Other solvents for injection:

1, water-soluble non-aqueous solvents: ethanol, glycerol, 1, 2 propylene glycol, peg300 and PEG 400 are generally.

2. Surfactants: Tween 80, poloxamer 188, lecithin, as solubilization, wetting and emulsification.

3. suspending agents: gelatin, mc, cmc-na, used for suspension injection.

4. Additives for delaying oxidation: sodium metabisulfite (acidic), sodium bisulfite (neutral), sodium thiosulfate (alkaline), edta and co2.

5. Isotonic regulators: sodium chloride and glucose.

6. Local analgesics: benzyl alcohol and trichlorotert-butanol.

7. bacteriostatic agent: benzyl alcohol, trichlorotert-butanol, thiomersal, vein and spine should not be added with bacteriostatic agent > 5ml at a time.

8. Others: stabilizers, fillers and protectants.

Preparation of injection

1. Technological process and environmental requirements of injection: 1, sterile and pyrogen-free; 2. clarity.

2. Container and handling of injection: acid and alkali resistance, neutrality, low expansion coefficient, low melting point, easy melting and easy sealing. Glass container treatment:

1, ampoule: acid resistance, alkali resistance, neutral test, China stipulates the use of easy-to-break ampoules with notched color points. Washing: Steam the bottle and inject 100℃ pure water for 30 min to improve the chemical stability. ① Water-throwing washing method: less than 5ml② Pressurized air-water jet washing method: 10ml or more; ③ Drying or sterilization: generally, it is dried in an oven at 120- 140℃ and electrically heated in an infrared tunnel oven; Sterility: 180℃ dry heat