Inspection Method of Chinese Medicine Tablets

1.

Regarding the quality requirements of tablets, the appearance should be complete and clean, the color should be uniform, and the hardness should be appropriate.

(1) Weight difference check

1.

2.

(1) Take 20 pieces of the test product, accurately weigh the total weight, and obtain the average piece weight

(2) From the 20 pieces of test samples whose total weight has been weighed, take out one piece in turn with tweezers, and accurately weigh each piece separately

(3) The weight of each tablet is compared with the labeled tablet weight (the tablet without a labeled tablet weight is compared with the average tablet weight)

3.

(1) Sugar-coated tablets should be checked for the difference in core weight before coating, and can be coated only after they meet the requirements

(2) The weight difference of film-coated tablets should be checked after coating

(3) Other coated tablets (such as enteric coated tablets and those coated with talc, Indigo Naturalis, cinnabar, ocher, etc.

(4) Avoid direct contact with the test product with your fingers during the weighing process

(5) The tablets that have been taken out shall not be put back into the original packaging container of the test product

(6) For tablets whose content uniformity is required to be inspected, the weight difference inspection is generally no longer required

4.

(1) The weight of each tablet is compared with the average tablet weight (for tablets without content determination or Chinese medicine tablets with labeled tablet weight, the weight of each tablet should be compared with the labeled tablet weight), according to the provisions of Table 15-1, exceeding The weight difference limit shall not be more than 2 pieces, and one piece shall not exceed the limit by 1 time

Table 15-1 Limits of difference in tablet weight

(2) If the weight difference limit is exceeded by more than 2 pieces, or the weight difference limit is not more than 2 pieces, but one piece exceeds the weight difference limit by 1 time, it will be judged as non-compliance
.

5.
Records and calculations

(1) Record the model of the balance
.

(2) Record the data of each weighing
.

(3) Calculate the allowable film weight range based on the indicated film weight or average film weight
.

(2) Disintegration time limit inspection

1.
Brief description

(1) The disintegration time limit means that the oral solid preparations disintegrate, dissolve or break into granules within the inspection time limit, and pass through a screen
.

(2) This law is applicable to the inspection of the disintegration time limit of tablets
.
After the tablet is taken orally, it needs to be disintegrated and dissolved before it can be absorbed by the body to achieve the purpose of treatment
.

(3) Except for chewable tablets, the disintegration time limit is not checked; for vaginal tablets, the disintegration time limit is checked; other tablets should be checked for disintegration time limit
.

(4) Unless otherwise specified, the inspection shall comply with the requirements in accordance with the Disintegration Time Limit Inspection Law (General Rule 0921)
.

2.
Method of operation

(1) Disintegration instrument: For details of the instrument structure and operation method, please refer to the third section "IV.
Disintegration time limit inspection method" (General Rule 0921)
.

(2) Oral ordinary tablets: Take 6 tablets of the test product, put them into the glass tubes of the above hanging basket, add 1 tablet to each tube, add a baffle, and start the disintegrator for inspection
.
All should be disintegrated within the prescribed time limit
.
If the sample to be tested adheres to the baffle, another 6 pieces should be taken, without the baffle, check according to the above device and method, and it should meet the requirements
.
If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements
.

Raw medicinal powder tablets: All tablets should be completely disintegrated within 30 minutes
.

Extract (semi-extract) tablets: All tablets should be completely disintegrated within 1 hour
.

Sugar-coated tablets: All tablets should disintegrate within 1 hour
.

Film-coated tablets: Check according to the above device and method, and can be changed to check in hydrochloric acid solution (9→1000)
.
All tablets should all disintegrate within 1 hour
.
If the test product adheres to the baffle, another 6 pieces shall be taken, and the inspection shall be carried out according to the above method without the baffle, and shall meet the requirements
.
If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements
.

Enteric-coated tablets: According to the above-mentioned device and method, check without baffle
.
First check in the hydrochloric acid solution (9→1000) for 2 hours, each piece shall not have cracks, disintegration or softening; after taking out the hanging basket, washing with a small amount of water, adding baffles to each pipe, and then in accordance with the above method Check in phosphate buffer (pH 6.
8)
.
All should disintegrate within 1 hour
.
If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements
.

(3) Buccal tablets: Take 6 tablets of the test product and check according to the above-mentioned device and method.
All tablets should not disintegrate or melt within 10 minutes
.
If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements
.

(4) Effervescent tablet: Take 1 tablet of the test product and place it in a 250ml beaker.
The beaker contains 200ml of water.
The water temperature is 20±5℃.
Many bubbles are released.
When the gas around the tablet or fragments stops escaping , The tablet should be dissolved or dispersed in water, without agglomerated particles remaining
.
Unless otherwise specified, 6 tablets shall be inspected by the same method, and each tablet shall disintegrate within 5 minutes
.
If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements
.

(5) Vaginal tablets: Operate in accordance with the "Melting Time Limit Inspection Method" (General Rule 0922).
Take 3 test samples and place them in the suppository inspection device (the hook end of the metal frame hook should be down and upside down.
On the metal disc on the top of the container, the device is covered with a glass plate for inspection
.
All should be dissolved or disintegrated within 30 minutes
.
If one tablet cannot be completely melted or disintegrated, another 3 tablets should be taken for re-testing, all of which should meet the requirements
.

Generally, the disintegration time limit inspection is no longer required for tablets that require the inspection of dissolution and release
.

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 test samples 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) For tablets that require the inspection of dissolution, release or uniformity of dispersion, the disintegration time limit inspection is generally no longer required
.

4.
Results and Judgment

(1) Take 6 tablets of the test product, which can all disintegrate and pass through the screen within the time limit specified in Table 15-2; for tablets containing medicinal extracts, resins, oils, or a large amount of gelatinized starch, if any Part of the particles that fail to pass through the screen, but have been softened and have no hard core, are judged to meet the requirements
.

(2) Take 6 pieces of the test product, and if one or more pieces cannot be completely disintegrated within the prescribed time limit, and cannot pass through the screen, it will be judged as non-compliance
.

(3) When the enteric-coated tablet is inspected in a hydrochloric acid solution (9→1000), if cracks, disintegration or softening are found, it is judged as non-compliant
.

(4) Three vaginal tablets of the test product should be completely melted or disintegrated within 30 minutes and passed through the perforated metal disc, or if only a small amount of soft mass without hard core remains, it is judged to meet the requirements ; otherwise judged as non-compliant
.

(5) Take 6 tablets of the test product, each tablet should not disintegrate or melt within 10 minutes
.

Table 15-2 Time limit inspection of tablet disintegration

5.
Record

(1) type recording apparatus, the type of tablets, solvent, temperature, and time disintegration
.

(2) If it does not disintegrate within the specified time limit, the extended time and the number of non-compliant pieces and phenomena shall be recorded
.

(3) Inspection of foaming volume

1.
Brief description This method is used to check the foaming volume of solid preparations such as vaginal effervescent tablets under specified conditions
.

2.
Operation method Unless otherwise specified, take 10 25ml test tubes with stopper (inner diameter 1.
5cm, if the tablet diameter is larger, the inner diameter can be changed to 2.
0cm), add a certain amount of water according to the regulations in Table 15-3 , Put in a 37℃±1℃ water bath for 5 minutes, put one piece of test product into each tube, observe the volume of the maximum foaming volume within 20 minutes, the average foaming volume shall not be less than 6ml, and the volume of less than 4ml shall not exceed 2 Slices
.

Table 15-3 Checking the amount of tablet foaming and adding water

3.
Matters needing attention

(1) The test tube with stopper scale should be clean, dry and free of water droplets on the inner wall
.

(2) During the test, the water temperature in the test tube with stopper should be kept at 37℃±1℃
.

4.
Results and Judgment

(1) If the average foaming volume of 10 pieces is not less than 6ml, and less than 4ml does not exceed 2 pieces, they are all judged to meet the requirements
.

(2) If the average foam volume of 10 pieces is less than 6ml, or less than 4ml in 10 pieces and more than 2 pieces, it will be judged as non-compliance
.

5.
Record the solvent, temperature, time and foam volume
.

(4) Dispersion uniformity inspection

The dispersible tablets are inspected according to the following methods and should meet the requirements
.

Using a disintegration time limit inspection device, the inner diameter of the sieve of the stainless steel wire mesh is 710um, and the water temperature is 15～25℃; 6 pieces of the test sample should be taken within 3 minutes and all should be disintegrated and passed through the sieve
.

(5) Microbial limit inspection

Unless otherwise specified, use non-monomeric tablets derived from animals, plants, minerals, mucous membranes or skin inflammations or cavities and other topical tablets (such as oral patches, topical soluble tablets, vaginal tablets, vaginal effervescent tablets) ), according to the microbial limit inspection of non-sterile products: the microbial counting method (General Rule 1105) and the control bacteria inspection method (General Rule 1106) and the microbiological limit standard of non-sterile drugs (General Rule 1107) shall meet the requirements
.