solution injection

Emulsion type injection

Suspension injection

I. Overview

2. Classification

Intravenous injection (injection volume is generally 5-50ml)

Intravenous drip (also called large infusion)

Most of them are aqueous solutions; oil solutions and suspensions/emulsions can easily cause capillary embolism and are generally not suitable for intravenous injection. However, particulate dispersion systems such as emulsions, nanoparticles, and liposomes with particle sizes <1um can also be used for intravenous injection.

The injection dose is generally 1-5ml

Aqueous solutions, oil solutions, suspensions and emulsions are available for intramuscular injection

The general dosage is 1-2ml;

Mainly aqueous solution

Commonly used for allergy testing or disease diagnosis such as: penicillin skin test, diphtheria diagnostic toxin, etc.

For poorly soluble drugs, injection oil can be used as the solvent

Common injection oils mainly include soybean oil, sesame oil, tea oil and other vegetable oils;

Important indicators for evaluating the quality of injection oil - iodine value, saponification value, acid value

Solvent polarity can be adjusted to increase the solubility of poorly soluble drugs

If the ethanol concentration exceeds 10%, injection administration may cause hemolysis or pain.

Aseptic production process

terminal sterilization process

The pH strives to be close to body fluids, and the osmotic pressure is as isotonic as possible with blood;

The infusion dose is more than 100ml

Aqueous injection

intravenous drip

General injections do not require or have hemodynamic properties

No bacteriostatic agents, solubilizers, analgesics or other additives may be added to the infusion.

From configuration to sterilization should be completed within 4 hours

electrolyte infusion

acid-base balance infusion

Function: Used to provide nutrients such as sugar, fat, amino acids, trace elements, and vitamins. It is mainly used for patients who cannot absorb nutrients orally.

Function: Used to regulate osmotic pressure in the body.

For patients requiring blood purification treatment.

Pickling method

Alkaline cleaning method

Direct water washing method

plastic bottle

plastic soft bag

It is suitable for use when the quality of the raw materials is good, the concentration of the liquid medicine is not high, and the volume of liquid preparation is not too large.

Pyrogen: refers to the general term for heating substances that can cause an abnormal increase in body temperature of warm-blooded animals and humans. It is an endotoxin produced by bacteria and other microorganisms. Pyrogens produced by Gram-negative bacilli and fungi have the greatest heat-generating ability. powerful.

Lipopolysaccharide is the major component of endotoxins

1. Heat resistance

2. Filterability

3. Adsorption

4. Water solubility

5. Non-volatile

6. Others (can be destroyed by strong acids, strong bases and strong oxidants)

(1) Water for injection

(2) Raw and auxiliary materials

(3) Production process

(4) Containers, utensils, pipes and devices

(5) Infusion equipment

(1) High temperature method

(2) Acid-base method

(3) Adsorption method

(4) Distillation method

(5) Gel filtration method

(6) Reverse osmosis method

(7) Ultrafiltration method

(8) Other methods