solution injection

Emulsion type injection

Suspension injection

Divided into intravenous push injection and intravenous drip. Non-aqueous solutions and suspensions cannot be used, and the injections used must not add bacteriostatic agents.

The dosage is 1 to 5ml. Drugs that are too irritating should not be used.

Mainly aqueous solution, dosage 1~2ml

≤0.2ml, allergy test or disease diagnosis

The osmotic pressure and pH of the injection should be equal to those of the spinal fluid It does not contain particles, the amount does not exceed 10ml, and no inhibitors are allowed.

Intra-articular injection, intracardiac injection, acupoint injection, intra-synovial cavity injection

Mainly include soybean oil, sesame oil, tea oil and other vegetable oils

Evaluation index: alkali value, acid value, saponification value

Can be injected intravenously or intramuscularly However, when the concentration exceeds 10%, hemolysis or pain may occur.

It can be injected intravenously or intramuscularly. The commonly used concentration in mixed solvents is 10%-60%.

Commonly used concentrations are 1%-50%

It can be injected intravenously or intramuscularly, and the usual concentration is 1%-50%.

Commonly used concentration is 0.01%

ampoule

Vial

infusion bottle, infusion bag

Neck ampoule

powder ampoule

Pressurized air and water alternating jet washing method

Ultrasonic cleaning method

Drainage washing method

No-wash ampoules

Drying: 120℃～140℃ 2 hours

Sterilization: 180℃ dry heat sterilization for 1.5 hours

Sterile ampoules should be stored for no more than 24 hours

It refers to adding all the drugs to part of the prescription amount of solvent to form a concentrated solution, heating or refrigeration, filtering, and then diluting to the required concentration.

It is suitable for raw materials of poor quality and can filter out some impurities with low solubility.

It refers to adding the drug to all the solvents in the prescription amount to directly prepare it to the required concentration. then filter

This method is easy to operate and suitable for high-quality raw materials.

Osmotic pressure and blood isotonicity and isotonicity

The infusion dose is more than 100ml, the maximum is 1000ml, usually 500ml

Usually administered by intravenous drip

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

The time from preparation to sterilization of small-volume injections is generally controlled within 12 hours. The time from preparation to sterilization of infusion is within 4 hours

Replenish body water, electrolytes, and maintain acid-base balance in the body Example: sodium chloride injection, sodium bicarbonate injection, sodium lactate injection

For patients who cannot absorb nutrients orally Example: carbohydrate infusion, amino acid infusion, fat emulsion infusion

Regulate osmotic pressure in the body Examples: polysaccharides, gelatins, high molecular polymers

Infusions containing therapeutic drugs

For patients requiring blood purification treatment

Pickling method

Alkaline cleaning method

Direct water washing method

plastic bottle

plastic soft bag

No acid and alkali treatment is required, just use distilled water for dynamic rinsing without adding an isolation film. The temperature does not exceed 121°C, dry, sealed and ready for use

Use fresh pyrogen-free water for injection

Carefully clean preparation containers, filtration devices and delivery pipes

Clean immediately after use and sterilize regularly

Concentrated preparation method (multi-purpose)

Dilute method

It refers to the general term for pyrogenic substances that can cause abnormal increases in body temperature of warm-blooded animals and humans. It is an endotoxin produced by microorganisms such as bacteria. Pyrogens produced by Gram-negative bacilli and molds have the strongest pyrogenic ability.

heat resistance

Filterability

adsorption

water soluble

non-volatile

other

Water for Injection

Raw materials

production process

Containers, utensils, pipes, devices

Infusion set

high temperature method

Acid-base method

adsorption method

Distillation

gel filtration

reverse osmosis method

Ultrafiltration

other

Sterile materials to be packaged have poor fluidity

Strictly control the entire production process of sterile packaging products to prevent contamination

Sterile Practice and Environment

Prevent drugs from decomposing due to high heat and dryness

The product is loose and porous and can be quickly dissolved after adding water.

Low moisture content, can remove 95% to 99% of moisture

Less chance of contamination

Accurate dosage and excellent appearance

Solvents cannot be chosen arbitrarily

Requires special equipment and high cost

Solution preparation, sterile filtration, sterile dispensing

Down to 10℃~20℃ below the eutectic point

Divided into quick freezing and slow freezing

Set the condenser temperature to -45℃, evacuate (0.1mmHg), turn off the freezer, and slowly raise the temperature to about -20℃

One time sublimation method

Repeated pre-freezing sublimation method

Continue to heat up to 0℃ or room temperature

Seal immediately after freeze drying

The liquid layer is too thick, the heat supply is insufficient, the vacuum is insufficient, and the condenser temperature is too high.

Incomplete pre-freezing and heating too fast

Solution: The pre-freezing temperature should be 10°C to 20°C below the eutectic point, and the heating temperature should not exceed the eutectic point.

Products with high viscosity are prone to

Solution: Add filler, repeat pre-freezing and sublimation method