Aerosol inspection method (1)

Quality requirements for aerosols: solution-type aerosols should be clear; droplets of emulsion-type aerosols should be evenly dispersed in the liquid medium; suspension-type aerosols should be fine powder and additives Fully mix and grind to make a stable suspension

(1) Total inspections per bottle

1.

(1) This law is applicable to the inspection of the total number of presses per bottle of quantitative aerosol

(2) The purpose of this inspection is to control the aerosol metering valve device and the total number of taps per bottle

2.

(1) Check in accordance with the methods under the relevant items of inhalation preparations (General Rules 0111), and the total number of times each bottle should meet the requirements

(2) Take 1 bottle of the test sample, remove the cap, press the valve, and the interval between each withdrawal is not less than 5 seconds

3.

4.

(1) Check 1 bottle.

(2) Check 1 bottle, and the total number of times of each bottle is less than the total number of presses marked on each bottle, and it is judged as non-compliance

5.

(1) Record the number of sprays of each bottle separately

(2) Record the total number of clicks for each bottle and the number of clicks for each bottle

(2) Inspection of uniformity of delivered dose

1.

2.

3.
Results and judgments are checked according to relevant methods, and compliance with requirements is judged as compliance with regulations
.

(3) Check the main drug content of each press

1.
Brief description

(1) This law is applicable to the inspection of the main drug content of each press of a quantitative aerosol
.

(2) The metered valve aerosol is administered with each tap.
The purpose of this inspection is to ensure the accuracy of the main drug content in each spray
.

2.
Method of operation

(1) Take a bottle of the test product, shake it fully, remove the cap, and spray for 5 times.
Wash the nozzle with the solvent specified for the species.
After it is fully dried, invert the bottle (vertical) and add a certain amount to absorb it.
In a suitable beaker of liquid, immerse the nozzle below the surface of the absorption liquid (at least 2.
5 cm)
.

(2) Unless otherwise specified, press and spray 10 or 20 times (note that the interval between each spray is 5 seconds and shake slowly), take out the medicine bottle, wash the inside and outside of the nozzle with absorbent, and combine the absorbent
.
Transfer to an appropriate volume bottle and dilute to the mark, shake well, and measure
.

(3) Measure according to the method under the content determination item of each variety, and divide the result obtained by the number of sampling injections (10 or 20 times), which is the average content of the main drug per press
.
The content of each main drug should be 80% to 120% of the labeled content of each main drug
.

3.
Matters needing attention Before spraying test, the sample to be tested should be fully shaken to make it even
.

4.
Results and Judgment

(1) Take 1 bottle of the test product and determine it according to the method under each category.
The average content of the main drug per press should be 80% to 120% of the labeled content, which is judged to meet the requirements
.

(2) If the average content of the main drug per press exceeds 80% to 120% of the labeled content, it will be judged as non-compliant
.

5.
Records and calculations

(1) Record the name of the washing solvent and absorbing liquid, the number of sprays, and the method of content determination
.

(2) Record the model of the analytical balance instrument used and the source and batch number of the reference substance
.

(3) The result obtained is divided by the number of sampling injections (10 times or 20 times), which is the average content of the main medicine per press
.

(4) Dose inspection of fine particles

1.
Brief description This method is applicable to the inspection of the fine particle dose of inhaled aerosols.
The purpose of this inspection is to control the drug particle size of inhaled aerosols
.

2.
Operation method Unless otherwise specified, inhalation sprays shall be inspected according to the aerodynamic characteristics of inhaled preparations (General Principle 0951), and shall be measured according to the specified devices and methods under each category.
Unless otherwise specified, The dose of fine particles should not be less than 15% of the labeled amount of the main drug content for each press
.

3.
The results and judgments shall be determined according to the methods under each category.
Unless otherwise specified, the dose of fine particles shall not be less than 15% of the labelled amount of each main drug
.
It was judged to be in compliance with the regulations
.

(5) Inspection of injection rate

1.
Brief description

(1) This law is applicable to the inspection of the injection rate of non-quantitative aerosols
.

(2) Non-quantitative valve aerosols are administered according to the length of the press-injection time.
The purpose of this inspection is to control the ejection of uniform droplets at a constant speed
.

2.
Method of operation

(1) Take 4 bottles of the test sample, remove the caps, shake them, separate/press the valve to spray for a few seconds, wipe clean, and accurately weigh them separately (W1)
.

(2) Immerse it in a constant temperature water bath (25°C±1°C) for 30 minutes, take it out, wipe it dry, and shake it evenly
.
Unless otherwise specified, press the valve separately and continuously and accurately spray for 5 seconds, wipe clean, and accurately weigh each (W2)
.

(3) Put it in a constant temperature water bath (25℃±1℃), repeat the operation 3 times according to the above method, and calculate the average spray rate (g/s) of each bottle
.

3.
Matters needing attention

(1) The spray speed should be uniform and the force should be consistent
.

(2) When weighing each bottle of aerosol, pay attention to the sequence of numbers
.

4.
Results and Judgment The average spray rate (g/s) of each bottle of 4 bottles of test samples shall be in accordance with the regulations under each category
.

5.
Records and calculations

(1) Record the analytical balance model and each weighing data
.

(2) Calculate each injection rate by the following formula
.

V=(W ₁ -W ₂ )/S.
.
.
.
.
.
.
.
.
.
(Equation 15-2)

In the formula, V is the rate of each injection (g/s); (W ₁ -W ₂ ) is the difference between the weight before and after the injection, that is, the weight (g) of the content of each injection; S is the duration of each injection
.

(3) A total of 4 measurements for each bottle, calculate the average spray rate (g/s) of each bottle
.

Related Links: Inspection Method of Chinese Medicine Sprays (2)