Inspection method of Chinese medicine spray (1)

The quality requirements of sprays: the liquid of solution sprays should be clear; the droplets of emulsion sprays should be evenly dispersed in the liquid medium; suspension sprays should be thoroughly mixed with fine powders and additives , Grind and make a stable suspension

In addition to meeting the requirements of aerosols, inhalation sprays should also meet the requirements of inhalation preparations (General Rules 0111); nasal sprays should meet the requirements of nasal preparations (General Rules 0106) in addition to meeting the requirements of aerosols.

In addition to the inspection items specified under each category of sprays, multi-dose quantitative sprays check the total spray times per bottle, quantitative sprays check each spray volume, each spray main drug content, quantitative inhalation spray, suspension type and Emulsion quantitative nasal sprays should be checked for the uniformity of the delivered dose.

(1) Check the total number of sprays per bottle

1.

(1) This law is applicable to the inspection of the total number of sprays per bottle of multi-dose quantitative sprays

(2) The purpose of this inspection is to control the metering valve spray device and the total spray times per bottle

2.

(1) Take 4 bottles of the test sample, remove the caps, shake them fully, press the valves in a fume hood and spray continuously into the 1000ml or 2000ml conical flasks that have been added with the appropriate amount of absorption liquid, pay attention to the interval of 5 seconds between each spray And shake slowly until the spray is exhausted

(2) Calculate the number of sprays of each bottle separately, and the total number of sprays of each bottle shall not be less than the total number of sprays indicated on it

3.

4.

(1) Check 4 bottles.

(2) If the total number of sprays for one or more bottles is less than the total number of sprays for each bottle, it will be judged as non-compliant

5.

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

(2) Record the total number of sprays per bottle and the number of sprays marked on each bottle

(2) Inspection of each spray volume

1.
Brief description

(1) This law is applicable to the inspection of each spray volume of quantitative sprays
.

(2) The purpose of this inspection is to control the accuracy of each spray volume
.

(3) For sprays that are inspected for the uniformity of the main drug content or delivered dose per spray, the spray volume per spray is no longer checked
.

2.
Method of operation

(1) Take 4 bottles of the test sample, remove the cap, press the valve to spray several times in the container, wipe clean, accurately weigh, and then spray 3 times continuously, wipe clean after each spray, accurately weigh , Calculate each spray volume
.

(2) Spray 10 times continuously, wipe clean, and weigh accurately
.

(3) Then measure the spray volume for 3 times according to the above method, continue to spray 10 times, and measure the spray volume for 4 more times according to the above method
.

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

3.
Matters needing attention During the spraying process, please press the valve after shaking to ensure one spray every time
.

4.
Results and Judgment

(1) Check 4 bottles, 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 label 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
.
Compare with the indicated spray volume
.

(3) Check the main medicine content of each spray

1.
Brief description

(1) This law is applicable to the inspection of the main drug content of each spray of quantitative sprays
.

(2) The dosing of quantitative valve sprays is based on each spray.
The purpose of this inspection is to ensure the accuracy of the main drug content in each spray
.

(3) For sprays that require the determination of the uniformity of the delivered dose, the determination of the main drug content per spray is generally no longer required
.

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 main drug content per injection
.
The content of the main drug in each spray should be 80% to 120% of the labeled content
.

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 spray 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 spray 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 or 20 times), which is the average main drug content per injection
.

Related links: Chinese medicine ointment, cream inspection method