Chinese medicine ointment and cream inspection method

The quality requirements of ointments and creams: there should be no rancidity, odor, discoloration, hardening and other deterioration phenomena

(1) Granularity inspection

1.

2.

(1) Calibration of the eyepiece micrometer: calibrate according to the microscopic identification method (General Rules 2001)

(2) Measurement method: Check according to the particle size and particle size distribution measurement method (General Rule 0982 First Method Microscope Method)

(3) Suspended ointment: Take an appropriate amount of the test product, place it on the glass slide, and apply a thin layer.

3.

(1) When sampling directly, the sampling amount should be appropriate (about 0.

(2) For particles with irregular shapes, the maximum value is the size of the particle during measurement

4.

(1) Among the 3 smears examined under the microscope, if the number of particles larger than 180um is not detected, it is judged to meet the requirements

(2) If the number of particles larger than 180um is detected, it will be judged as non-compliance

5.

(1) Record the microscope model and the number of smears

(2) Record the number of particles larger than 180um

(2) Checking the quantity

1.

2.
The method of operation is in accordance with the minimum loading inspection method (general rule 0942)
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3.
The precautions are the same as the minimum loading inspection method
.

4.
Results and Judgment

(1) The filling and average filling of the contents of each container shall be in accordance with the minimum filling inspection method (gravity method or volumetric method), and the filling volume of each container shall not be less than the allowable minimum filling volume; and the average filling shall be If the quantity is not less than the marked quantity, it will be judged to meet the requirements
.

(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 volume and the volume per container (calculate the percentage based on the marked filling volume, and take three significant digits to judge the result
.

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

(3) Sterility inspection

Unless otherwise specified, ointments and creams used for burns or severe wounds shall be inspected according to the sterility inspection method (General Principle 1101) and shall meet the requirements
.

(4) Microbial limit inspection

Unless otherwise specified, ointments and creams shall be inspected according to the microbial limit of non-sterile products: microbial counting method (General Rule 1105) and control bacteria inspection (General Rule 1106) and non-sterile drug microbial limit standard (General Rule 1107) inspection, should Meet the regulations
.