Aerosol inspection method (2)

(6) Inspection of total discharge

1.

(1) This law applies to the inspection of the total amount of non-quantitative aerosol spray

(2) The purpose of this inspection is to control the non-quantitative valve aerosol device and the amount that can be sprayed

2.

(1) Take 4 bottles of test samples, remove the caps, and accurately weigh them respectively (W1)

(2) Shake the test product evenly, in a fume hood, press the valve to spray continuously into a 1000ml or 2000ml conical flask that has added an appropriate amount of absorption liquid until the spray is exhausted, wipe it off, and accurately weigh each ( W2)

3.

(1) The liquid medicine must be sprayed out, otherwise, the total sprayed amount will be affected

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

4.

5.

(1) Record the model of the analytical balance

(2) Record the weighing data of each bottle before and after spraying (4 bottles in total)

(3) Calculate the spray volume of each bottle according to the following formula

W=W ₁ -W ₂ .

In the formula, W is the total amount of spraying per bottle; W1 is the weight before spraying; W2 is the weight after spraying

(7) Inspection of each spray volume

1.

(1) This law is applicable to the inspection of each spray volume of a quantitative aerosol
.
The purpose of this inspection is to control the accuracy of each spray volume
.

(2) For aerosols that are inspected for the uniformity of the delivered dose per press, the inspection of the volume per press is no longer required
.

2.
Method of operation

(1) Take 4 bottles of the test sample, remove the caps, press the valve to spray several times in the container, wipe clean, accurately weigh (W1), press the valve to spray once, wipe clean, and then weigh accurately Set (W2)
.
The difference between the two weights before and after is 1 spray volume
.

(2) Measure 3 spray volumes continuously according to the above method
.

(3) Press the valve to spray continuously (10 times) regardless of weight, with an interval of 5 seconds each time, and then measure 4 spray volumes continuously according to the above method
.

(4) Regardless of weight, press the valve for continuous injection (10 times)
.
Each interval is 5 seconds, and then 3 spray volumes are measured continuously according to the above method
.

(5) Calculate the average of 10 spray volumes per bottle
.
Unless otherwise specified, it should be 80% to 120% of the marked spray volume
.

3.
Matters needing attention During the spraying process, pay attention to shaking and then press the valve to ensure that each spray is full
.

4.
Results and Judgment

(1) Inspect 4 bottles, and the average value of each spray volume of 10 spray volume per bottle is 80%～120% of the marked spray volume, and it is judged as conforming to the regulations
.

(2) If the average spray volume of one bottle exceeds the range of 80%～120% of the marked spray volume, it is judged as non-compliance
.

5.
Records and calculations

(1) Record the 10 sprays of each bottle separately
.

(2) Record the marked spray volume of each bottle
.

(3) Calculate the average of 10 spray volumes per bottle and compare with the marked spray volume
.

(8) Particle size inspection

1.
Brief description

(1) This law is applicable to the inspection of suspension aerosols for inhalation of traditional Chinese medicine
.
If the dosing of fine particles is not carried out, a particle size inspection should be performed
.

(2) The purpose of this inspection is to control the particle size of the suspension aerosol for inhalation
.

2.
Method of operation

(1) Take a bottle of the test product, shake it fully, remove the cap, test spray several times, and wipe dry
.

(2) Take a clean and dry glass slide and spray it once at a distance of 5 cm from the nozzle vertical direction.
Carefully rinse the spray on the glass slide with about 2ml of carbon tetrachloride , absorb the excess carbon tetrachloride, and wait for it to dry.
Cover with a cover glass, displace and inspect under a 400x microscope with a micrometer, move up and down, left and right, check 25 fields of view, and count
.

(3) The average drug particle size should be less than 5um, and the particle size greater than 10um should not exceed 10 particles
.

3.
Matters needing attention

(1) Carefully rinse the spray on the glass slide with carbon tetrachloride so as not to wash away the particles
.

(2) If the suspension type aerosol for inhalation of traditional Chinese medicine is not subject to the dosing of fine particles, the particle size should be checked
.

4.
Results and Judgment

(1) Examine 25 fields of view under a microscope.
If the average drug particle size is less than 5um, and the particle size greater than 10um does not exceed 10 particles, it is judged to meet the requirements
.

(2) The average drug particle size is below 5um, but the particles larger than 10um exceed 10 particles
.
It was judged not to meet the regulations
.

5.
Record and calculate the microscope model and the number of particles of the test sample
.

(9) Checking the quantity

1.
Brief description This law is applicable to the inspection of non-quantitative aerosols.
The purpose of this inspection is to ensure the accuracy of the dosage
.

2.
The method of operation is in accordance with the minimum loading inspection method (general rule 0942)
.

3.
The precautions are the same as the minimum loading inspection method
.

4.
Results and Judgment

(1) The filling quantity and average filling quantity of the contents of each container, according to the minimum filling quantity inspection method, the filling quantity of each container shall not be less than the allowable minimum filling quantity; and the average filling quantity shall not be less than the marked filling quantity , It was judged to be in compliance with the regulations
.

(2) If one container does not meet the requirements, take another 5 (3 for 50ml or more) for retest
.
All the results of the retest meet the requirements, but they can still be judged as in compliance
.

(3) The average filling quantity and the filling quantity of each container are calculated according to the label filling quantity to calculate the percentage of the label filling quantity, and the result shall be judged with three significant figures
.

5.
Records and calculations are the same as the minimum loading inspection method
.

(10) Sterility inspection

Unless otherwise specified, aerosols used for burns, severe wounds or clinically necessary sterility shall be checked according to the sterility inspection method (General Principle 1101) and shall meet the requirements
.

(11) Microbial limit inspection

Unless otherwise specified, aerosols shall comply with the microbiological limit inspection method: microbial counting method (General Rule 1105) and control bacteria inspection (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) inspection should meet the requirements
.