Inspection Method of Chinese Medicine Pills (2)

(3) Checking the difference in loading

1.

2.

(1) Take 10 bags (bottles) of the test sample, weigh them separately, open the seal, pour out the contents, and then weigh the weight of each empty packaging bag (bottle) separately to obtain each bag (bottle) The weight of the contents (load quantity).

(2) Compare the volume of each bag (bottle) with the labeled volume

3.

(1) Multi-dose packaged pills marked by weight will not be checked for differences in filling quantities

(2) Do not directly touch the test product with your fingers during the weighing process

4.

(1) Comparing the volume of each bag (bottle) with the labeled volume, according to the provisions of Table 15-16, none of them exceed the limit of the difference in the volume, or exceed the limit of the difference in the volume by no more than 2 bags (bottles), and both Those that do not exceed the limit of 1 times the difference in loading quantity shall be judged to comply with the regulations

Table 15-16 Limits of the difference in the quantity of single-dose packaged pills

(2) If more than 2 bags (bottles) exceed the limit of the difference in filling quantity, or if the difference exceeds the limit of filling quantity not more than 2 bags (bottles) but one bag (bottle) exceeds the limit of filling quantity by 1 time, both It was judged not to meet the regulations

5.

(1) Record the model of the analytical balance

(2) data is recorded for each weighing and the like

(3) Calculate the weight of the contents of each bag (bottle)

(4) Calculate the allowable loading range based on the indicated loading volume

(4) Checking the quantity

1.
Brief description This law is applicable to the inspection of the quantity of multi-dose packaged pills indicated by weight
.
The purpose of this inspection is to control the minimum amount of pills
.

2.
Method of operation

(1) Multi-dose packaged pills marked by weight shall be operated in accordance with the minimum filling inspection method (gravimetric method) (General Rule 0942)
.

(2) Take 5 test samples (with a labeling capacity of more than 50g, take 3), remove the outer cover and label, clean and dry the outer wall of the container with a suitable method, accurately weigh them, remove the contents, and use the appropriate container The solvent is washed and dried, and then the weight of the empty container is accurately weighed, and the volume and average volume of the contents of each container are calculated
.

3.
Matters needing attention

(1) In the two weighings of each test product, attention should be paid to the sequence of numbers and the matching of empty containers
.

(2) Do not directly touch the test product with your fingers during the weighing process
.

(3) For multi-dose packaged pills indicated by the number of pills, the filling quantity is not checked
.

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 (gravimetric method) (General Rule 0942).
The filling volume of each container shall not be less than the minimum allowable filling volume and the average filling volume shall be If the quantity is not less than the marked quantity, it will be judged to meet the requirements
.
If one container does not meet the requirements, take another 5 (3 for 50g or more) for retest
.
All the results of the retest meet the requirements, but they can still be judged as in compliance
.

(2) The average filling quantity and the filling quantity of each container (calculate the percentage according to the marked filling quantity), and the result shall be judged by three significant figures
.

5.
Records and calculations

(1) Record the model of the analytical balance
.

(2) Record the weighing data of the contents of each container, the weight of each test product and the weight of its own empty container
.

(3) Divide the total volume of each container by 5 (or 3) to get the average volume
.

(4) Calculate the volume and average volume of the contents of each container, and calculate the minimum allowable volume
.

(5) Dissolution time limit inspection

1.
Brief description

(1) This law is applicable to the inspection of the dissolution time limit of pills
.
After oral administration, the pill needs to be dissolved and dissolved before it can be absorbed by the body to achieve the purpose of treatment.
The purpose of this inspection is to control the quality of the product and ensure the efficacy
.

(2) Dissolution means that the solid preparations dissolve completely within the inspection time limit and pass through the screen
.

(3) Unless otherwise specified, the dissolution time limit of Dami Pills and pills that are crushed, chewed, or dispersed with boiling water, rice wine, etc.
, are not checked, and other pills should be checked for dissolution time limit
.

2.
Method of operation

(1) The inspection instrument used is a disintegration instrument.
For details of the instrument structure and operation method, please refer to the third section "IV.
Disintegration time limit inspection method"
.

(2) Hang the hanging basket on the metal bracket through the stainless steel shaft at the upper end, immerse it in a 1000ml beaker, and adjust the position of the hanging basket so that the screen is 25mm away from the bottom of the beaker when it is lowered.
The beaker contains a temperature of 37℃±1℃.
Water, adjust the height of the water level so that the screen is 15mm below the water surface when the hanging basket is raised
.

(3) Take 6 pellets of the test product, select the hanging baskets with the appropriate aperture screen according to Table 15-17, put them in the glass tubes of the hanging basket, add 1 pellet to each tube, according to the disintegration time limit inspection method (General Rule 0921 ) The method under the tablet item is checked with a baffle, and the drop pill is not checked with a baffle
.
During the operation, if the test product adheres to the baffle to prevent inspection, another 6 pellets of the test product should be taken for inspection without the baffle
.
All the above inspections should pass through the screen within the specified time
.
If there are fine particles that have not passed through the screen, but have been softened and have no hard cores, they can be regarded as conforming to the regulations
.

If one droplet cannot dissolve completely, another 6 droplets should be taken for re-testing, and all of them should meet the requirements
.
Gelatin-based dripping pills can be tested in artificial gastric juice
.

Table 15-17 Selection of the aperture of the basket screen

(4) The inspection of enteric-coated tablets under the inspection method of disintegration time limit of wax pellets (General Rule 0921) tablets shall meet the requirements
.
First check in hydrochloric acid solution (9→1000) for 2 hours, each pill shall not have cracks, disintegration or softening; continue to take out the hanging basket, wash with a small amount of water, add a baffle to each tube, and then follow the above method Check in phosphate buffer (pH 6.
8), all should be disintegrated within 1 hour
.
If one tablet fails to disintegrate completely, another 6 pills should be taken for re-testing, all of which should meet the requirements
.

3.
Matters needing attention

(1) During the test, the water temperature (or medium temperature) in the beaker should be kept at 37℃±1℃
.

(2) If the test product adheres to the baffle during the operation to prevent inspection, another 6 pellets of the test product should be taken for inspection without the baffle
.

(3) After the test, the inner wall of the glass tube, the screen, the baffle, etc.
of the hanging basket should be cleaned, and the water or the specified medium should be replaced
.

4.
Results and Judgment

(1) Take 6 pills of the test product, which can all dissolve and pass through the sieve within the time limit specified in Table 15-18; or if there are fine particles that have not passed through the sieve, but have been softened and have no hard cores , All were judged to be in compliance with the regulations
.

(2) Take 6 pills of the test product.
If 1 pill or more cannot be completely dissolved within the prescribed time limit and cannot pass through the screen, it will be judged as non-compliance
.

(3) The wax pellets were inspected in hydrochloric acid solution (9→1000) for 2 hours.
There were no cracks, dissolution or softening in the 6 pellets; all of the wax pellets were dissolved within 1 hour in phosphate buffer (pH 6.
8), and it was judged as Meet the regulations, otherwise it will be judged as non-compliance
.

Table 15-18 Pills dissolution time limit inspection

5.
Record

(1) type recording apparatus, pill type, test conditions, the mesh aperture, scattered dissolution time
.

(2) If it does not dissolve within the specified time limit, the extended time and the number of pellets that do not meet the requirements and phenomena should be recorded
.

(6) Microbial limit inspection

Unless otherwise specified, the pill shall be inspected according to the microbial limit of non-sterile products; the microbial enumeration method (General Rule 1105) and the inspection of controlled bacteria (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements
.

Related Links: Inspection Method of Chinese Medicine Pills (1)